Self-help Cognitive Behavioral Therapy Research Articles

Web-based guided self-help cognitive behavioral therapy-enhanced versus treatment as usual for binge-eating disorder: a randomized controlled trial protocol.

Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time while experiencing a loss of control. Cognitive behavioral therapy-enhanced (CBT-E) is a recommended treatment for binge-eating disorder and is typically offered through 20 sessions. Although binge-eating disorder is highly responsive to CBT-E, the cost of treating these patients is high. Therefore, it is crucial to evaluate the efficacy of low-intensity and low-cost treatments for binge-eating disorder that can be offered as a first line of treatment and be widely disseminated. The proposed noninferiority randomized controlled trial aims to determine the efficacy of web-based guided self-help CBT-E compared to treatment-as-usual CBT-E. Guided self-help will be based on a self-help program to stop binge eating, will be shorter in duration and lower intensity, and will require fewer therapist hours. Patients with binge-eating disorder (N = 180) will be randomly assigned to receive guided self-help or treatment-as-usual. Assessments will take place at baseline, mid-treatment, at the end of treatment, and at 20- and 40-weeks post-treatment. Treatment efficacy will be measured by examining the reduction in binge-eating days in the previous 28 days between baseline and the end of treatment between groups, with a noninferiority margin (Δ) of 1 binge-eating day. Secondary outcomes will include full remission, body shape dissatisfaction, therapeutic alliance, clinical impairment, health-related quality of life, attrition, and an economic evaluation to assess cost-effectiveness and cost-utility. The moderators examined will be baseline scores, demographic variables, and body mass index. It is expected that guided self-help is noninferior in efficacy compared to treatment-as-usual. The proposed study will be the first to directly compare the efficacy and economically evaluate a low-intensity and low-cost binge-eating disorder treatment compared to treatment-as-usual. If guided self-help is noninferior to treatment-as-usual in efficacy, it can be widely disseminated and used as a first line of treatment for patients with binge-eating disorder. The Dutch trial register number is R21.016. The study has been approved by the Medical Research Ethics Committees United on May 25th, 2021, case number NL76368.100.21.

Efficacy of internet-based self-help cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia symptoms among adults with sub-threshold insomnia symptoms: a randomized controlled trial

Efficacy of internet-based self-help cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia symptoms among adults with sub-threshold insomnia symptoms: a randomized controlled trial

A comparison of the effectiveness of cognitive behavioural interventions based on delivery features for elevated symptoms of depression in adolescents: A systematic review.

Depression is a public health problem and common amongst adolescents. Cognitive behavioural therapy (CBT) is widely used to treat adolescent depression but existing research does not provide clear conclusions regarding the relative effectiveness of different delivery modalities. The primary aim is to estimate the relative efficacy of different modes of CBT delivery compared with each other and control conditions for reducing depressive symptoms in adolescents. The secondary aim is to compare the different modes of delivery with regard to intervention completion/attrition (a proxy for intervention acceptability). The Cochrane Depression, Anxiety and Neurosis Clinical Trials Register was searched in April 2020. MEDLINE, PsycInfo, EMBASE, four other electronic databases, the CENTRAL trial registry, Google Scholar and Google were searched in November 2020, together with reference checking, citation searching and hand-searching of two databases. Randomised controlled trials (RCTs) of CBT interventions (irrespective of delivery mode) to reduce symptoms of depression in young people aged 10-19 years with clinically relevant symptoms or diagnosis of depression were included. Screening and data extraction were completed by two authors independently, with discrepancies addressed by a third author. CBT interventions were categorised as follows: group CBT, individual CBT, remote CBT, guided self-help, and unguided self-help. Effect on depressive symptom score was estimated across validated self-report measures using Hedges'g standardised mean difference. Acceptability was estimated based on loss to follow-up as an odds ratio. Treatment rankings were developed using the surface under the cumulative ranking curve (SUCRA). Pairwise meta-analyses were conducted using random effects models where there were two or more head-to-head trials. Network analyses were conducted using random effects models. Sixty-eight studies were included in the review. The mean age of participants ranged from 10 to 19.5 years, and on average 60% of participants were female. The majority of studies were conducted in schools (28) or universities (6); other settings included primary care, clinical settings and the home. The number of CBT sessions ranged from 1 to 16, the frequency of delivery from once every 2 weeks to twice a week and the duration of each session from 20 min to 2 h. The risk of bias was low across all domains for 23 studies, 24 studies had some concerns and the remaining 21 were assessed to be at high risk of bias. Sixty-two RCTs (representing 6435 participants) were included in the pairwise and network meta-analyses for post-intervention depressive symptom score at post-intervention. All pre-specified treatment and control categories were represented by at least one RCT. Although most CBT approaches, except remote CBT, demonstrated superiority over no intervention, no approaches performed clearly better than or equivalent to another. The highest and lowest ranking interventions were guided self-help (SUCRA 83%) and unguided self-help (SUCRA 51%), respectively (very low certainty in treatment ranking). Nineteen RCTs (3260 participants) were included in the pairwise and network meta-analyses for 6 to 12 month follow-up depressive symptom score. Neither guided self-help nor remote CBT were evaluated in the RCTs for this time point. Effects were generally attenuated for 6- to 12-month outcomes compared to posttest. No interventions demonstrated superiority to no intervention, although unguided self-help and group CBT both demonstrated superiority compared to TAU. No CBT approach demonstrated clear superiority over another. The highest and lowest ranking approaches were unguided self-help and individual CBT, respectively. Sixty-two RCTs (7347 participants) were included in the pairwise and network meta-analyses for intervention acceptability. All pre-specified treatment and control categories were represented by at least one RCT. Although point estimates tended to favour no intervention, no active treatments were clearly inferior. No CBT approach demonstrated clear superiority over another. The highest and lowest ranking active interventions were individual CBT and group CBT respectively. Pairwise meta-analytic findings were similar to those of the network meta-analysis for all analyses. There may be age-based subgroup effects on post-intervention depressive symptoms. Using the no intervention control group as the reference, the magnitudes of effects appear to be larger for the oldest age categories compared to the other subgroups for each given comparison. However, they were generally less precise and formal testing only indicated a significant difference for group CBT. Findings were robust to pre-specified sensitivity analyses separating out the type of placebo and excluding cluster-RCTs, as well as an additional analysis excluding studies where we had imputed standard deviations. At posttreatment, all active treatments (group CBT, individual CBT, guided self-help, and unguided self-help) except for remote CBT were more effective than no treatment. Guided self-help was the most highly ranked intervention but only evaluated in trials with the oldest adolescents (16-19 years). Moreover, the studies of guided self-help vary in the type and amount of therapist support provided and longer-term results are needed to determine whether effects persist. The magnitude of effects was generally attenuated for 6- to 12-month outcomes. Although unguided self-help was the lowest-ranked active intervention at post-intervention, it was the highest ranked at follow-up. This suggests the need for further research into whether interventions with self-directed elements enable young people to maintain effects by continuing or revisiting the intervention independently, and whether therapist support would improve long-term outcomes. There was no clear evidence that any active treatments were more acceptable to participants than any others. The relative effectiveness of intervention delivery modes must be taken into account in the context of the needs and preferences of individual young people, particularly as the differences between effect sizes were relatively small. Further research into the type and amount of therapist support that is most acceptable to young people and most cost-effective would be particularly useful.

P158: Efficacy of a self-help cognitive-behavioral therapy (GSH-CBT) guided by lay providers for generalized anxiety disorder (GAD) in older adults: preliminary results

Background:Only a small proportion of older adults with generalized anxiety disorder (GAD) seek professional help. One reason is the lack of access to mental health professionals licensed to provide psychotherapy. One way to improve access to psychotherapy is through guided self- help (GSH). GSH based on the principles of cognitive-behavior therapy (GSH-CBT) can be guided by trained lay providers (LPs). The purpose of this poster is to report preliminary results from a multisite randomized controlled trial testing the efficacy of a GSH-CBT guided by LPs for GAD in older adults.Methods:The sample included 150 participants (≥ 60 years old) with a diagnosis of threshold or subthreshold GAD randomly assigned to: 1) GSH-CBT guided by LPs (n = 75) or 2) waiting list (n = 75). The GSH-CBT lasted 15 weeks. Participants used a manual presenting weekly reading and at-home exercises. They also received weekly support calls (30 minutes maximum) by LPs (undergraduate psychology students) supervised by psychologists. Repeated-measures regression models were used to compare changes in the groups before and after 15 weeks on three outcomes: severity of GAD symptoms (Generalized Anxiety Disorder 7-item; GAD-7), tendency to worry (Penn State Worry Questionnaire; PSWQ), and level of anxiety (Geriatric Anxiety Inventory; GAI).Results:At the first assessment, both groups were similar in terms of age, sex, level of education, marital status, occupation, and did not differ significantly on outcomes. The GSH- CBT group decreased significantly on all three outcomes (GAD-7: -4.8, 95% CI [-5.7, -3.8], PSWQ: -11.7; 95% CI [-13.6, -9.9], GAI: -5.3 95% CI [-6.5, -4.1]) while the waiting list group remained stable over 15 weeks (GAD-7: -0.3, 95% CI [-1.2, 0.6], PSWQ: 0.7; 95% CI [-1.2, 2.5], GAI: -0.7 95% CI [-1.9, -0.5]).Conclusions:GSH-CBT guided by LPs appears to be an effective intervention for reducing severity of GAD symptoms, tendency to worry, and level of anxiety in older people with GAD. Further analyses will be conducted to test whether the intervention differs in efficacy between participants with a threshold vs. subthreshold GAD. The maintenance of long-term gains (6 and 12 months after the intervention) will also be tested.

Evaluating dietary restriction as a maintaining factor in binge-eating disorder.

Prominent theories of binge-eating (BE) maintenance highlight dietary restriction as a key precipitant of BE episodes. Consequently, treatment approaches for eating disorders (including binge-eating disorder; BED) seek to reduce dietary restriction in order to improve BE symptoms. The present study tested the hypothesis that dietary restriction promotes BE among 112 individuals with BED. Participants completed a 7-day ecological momentary assessment (EMA) protocol before and after completing 17 weeks of either Integrative Cognitive-Affective Therapy or guided self-help cognitive behavioral therapy. Analyses examined whether dietary restriction on 1 day of the baseline EMA protocol predicted risk for BE later that same day, and on the following day. Changes in dietary restriction over the course of treatment were also evaluated as a predictor of change in BE from pre-treatment to post-treatment. Baseline dietary restraint was examined as a moderator of the above associations. Dietary restriction did not predict BE later the same day, and changes in restriction were not related to changes in BE across treatment, regardless of baseline dietary restraint levels. Restriction on 1 day did predict increased BE risk on the following day for individuals with higher levels of dietary restraint, but not those with lower levels. These findings challenge the assumption that dietary restriction maintains BE among all individuals with BED. Rather, results suggest that dietary restriction may be largely unrelated to BE maintenance in this population, and that reducing dietary restriction generally does not have the intended effect on BE frequency.

A pilot trial of an online guided self-help cognitive behavioral therapy program for bulimia nervosa and binge eating disorder in Japanese patients

BackgroundThe purpose of this study was to develop an internet-based Guided Self-Help CBT (iGSH-CBT) for Bulimia Nervosa (BN) / Binge Eating Disorder (BED) for Japanese patients and to test its feasibility.MethodsA single-arm feasibility study. After baseline assessment, patients underwent a 16-week iGSH-CBT program, our Japanese adaption of the European-based Salut BN program. During the treatment period, weekly email support from trained counselors was provided. Evaluations were performed at baseline, after 8 weeks, at the end of the 16-week intervention, and at 2 months after treatment had ended. The primary outcome measure was the change in the weekly frequency of objective binging. Secondary outcomes were the change in the weekly frequency of objective purge episodes, responses on self-report questionnaires of the frequencies of binging and purging, psychopathological characteristics of eating disorders found on BITE, EDE-Q, EDI-2, HADS and EQ-5D, measurements of motivation, and completion of intervention (vs. dropout).ResultsParticipants were 9 female outpatients with BN (n = 5) or BED (n = 4), of whom 8 (88.9%) attended the assessment at the end of the 16-week intervention. Mean age was 28 years (SD = 7.9). Percent change of the weekly frequency of objective binging was -4.40%, and at the end of the 16-week intervention 25% of the participants had achieved symptom abstinence.ConclusionsNo adverse events were observed during the treatment period and follow-up, and the implementation and operation of the program could be performed without any major problems, confirming the feasibility of iGSH-CBT for BN and BED for Japanese patients. Although no significant change was observed in the weekly frequency of objective binging, the abstinence rate from bulimic behaviors of those who completed the assessments was 25.0% at the end of treatment, and the drop-out rate was 11.1%. iGSH-CBT may be an acceptable and possibly even a preferred method of CBT delivery for Japanese patients with BN or BED, and our Japanese adaptation of Salut BN seems feasible.Trial registrationUMIN, UMIN000031962. Registered 1 April 2018 - Retrospectively registered, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000036334

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3)

BackgroundThe National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training.MethodsThis study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation.DiscussionIf the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK’s National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated.Trial registrationCurrent Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Long-Term Efficacy of Internet-Based Cognitive Behavioral Therapy Self-Help Programs for Adults With Depression: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Depression is a worldwide mental disorder and a leading cause of disability. Many people with depression do not want to take medication or have the motivation to seek psychotherapy treatment for many reasons. Guided internet-based self-help programs may be a promising solution for addressing these issues. This kind of intervention has proven to be effective in reducing depression symptoms on a short-term scale. However, as treatment often is a long-term rehabilitation process, it is important to examine not only the short-term effects of internet-based cognitive behavioral therapy (iCBT) self-help treatment but also the follow-up or long-term efficacy of this kind of intervention. This systematic review and meta-analysis aimed to identify studies that examined follow-up data ≥8 weeks after posttreatment measurements and thereby examined the long-term efficacy of iCBT self-help programs with minimal weekly guidance for people with depression. It aimed to analyze the long-term efficacy of iCBT treatments compared to control conditions as well as long-term efficacy within the iCBT treatment conditions. Additionally, it aimed to conduct subgroup analyses according to the follow-up time points for each outcome. Finally, it examined long-term improvements in quality of life. The Cochrane Collaboration Depression, Anxiety, and Neurosis Controlled Trials Register (CCDANCTR), grey literature, reference lists, and correspondence were used to search for published and unpublished randomized controlled trials (RCTs) that reported the long-term or follow-up efficacy of computer-based or iCBT self-help treatments for depression with minimal guidance of up to 10 min/wk. The search took place between 2015 and 2022 (October). The search resulted in a total of 2809 study abstracts, of which 15 studies (with 17 samples) met all inclusion criteria and were included in the long-term analysis. The results showed that the depression outcomes of all follow-up time points together in the treatment conditions were favored over the control conditions with a medium effect size of 0.43 (n=1689 participants; 9 RCTs; standardized mean difference [SMD] -0.43, 95% CI -0.67 to -0.20; P<.001). The analysis of long-term efficacy within the iCBT treatment conditions showed that the follow-up outcomes of the treatment groups were favored over the posttreatment outcomes with a small effect size of 0.20 (n=2196 participants; 17 RCTs; SMD 0.20, 95% CI 0.07-0.49; P=.003). Findings for improving quality of life also showed that the iCBT conditions were favored over the control conditions with a small effect size of 0.19 (n=1345 participants; 3 RCTs; SMD 0.19, 95% CI 0.08-0.30; P<.001). This systematic review and meta-analysis found that iCBT self-help interventions had a superior long-term efficacy for individuals with depressive symptoms compared to control groups. The within-group analysis of iCBT treatment conditions also showed statistically significant improvements in reducing depressive symptoms at follow-up compared to posttreatment measurements.

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2)

BackgroundAndrogen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT.MethodsMANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6–8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team’s experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed.DiscussionMANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice.Trial registrationISRCTN reference 58720120. Registered 13 December 2022

0365 The Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia, Fatigue, and Quality of Life in Cancer Patients

Abstract Introduction The emotional, psychological and financial challenges of a cancer diagnosis profoundly affect patients and contribute to sleep difficulties. Insomnia affects 31%-54% of those newly diagnosed or undergoing treatment, and persists up to 5 years after treatment for cancer. Cognitive behavioral therapy (CBT) for insomnia is effective for sleep and insomnia outcomes, with no difference in outcomes for in-person or self-help CBT. Trials of digital CBT (dCBT) have recruited breast cancer survivors from Denmark and past pilot work did not identify statistically significant effects for fatigue and quality of life in US cancer survivors with insomnia. This study examined the effectiveness of a fully automated digital therapeutic (Sleepio) for improving insomnia, fatigue, and quality of life in patients with cancer from the US, UK, and Australia. Methods This is a secondary analysis of participants (n=70) with insomnia who self-reported a cancer diagnosis before randomization in a large effectiveness trial of dCBT for insomnia. Participants were randomized to receive either dCBT or a sleep hygiene education control. Insomnia (SCI-8), fatigue (FFS), and global health-related quality of life (PROMIS-10) were evaluated at baseline, 8-weeks post treatment and 24-weeks follow-up. Effect estimates are mean group differences, adjusted for baseline scores estimated using regression models. Results Digital CBT was superior to control for reducing symptoms of insomnia and fatigue at both post-treatment and follow-up (all p&amp;lt; 0.05). For the dCBT group, global PROMIS-10 scores were improved, although not significantly, at post-treatment (p=0.076), but were significantly higher at follow-up (p&amp;lt; 0.05). Conclusion Digital CBT was effective for reducing symptoms of insomnia and fatigue in patients with cancer and results were maintained after five and a half months. Significant improvements in global health-related quality of life scores at follow-up suggest effects extend beyond improvements to sleep. Findings may benefit patients with cancer as dCBT may provide scalable access to an effective treatment without contraindications. Further research is needed to understand the mechanisms and value of improving sleep in those with cancer and sleep difficulty. Support (if any) Big Health Inc.

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy–Enhanced for Binge Eating Disorder: Randomized Controlled Trial

Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to increase their access to specialized treatment. Guided self-help cognitive behavioral therapy-enhanced (CBT-E) may have great advantages for patients if its efficacy can be established. The aim of this study was to examine the efficacy of guided self-help CBT-E compared with that of a delayed-treatment control condition. A single-blind 2-arm randomized controlled trial was designed to evaluate guided self-help CBT-E according to an intention-to-treat analysis. A total of 180 patients were randomly assigned to guided self-help CBT-E (n=90, 50%) or the delayed-treatment control condition (n=90, 50%) for which guided self-help CBT-E was provided after the initial 12-week delay. The primary outcome was reduction in binges. The secondary outcome was full recovery at the end of treatment, as measured using the Eating Disorder Examination during the last 4 weeks of treatment. A linear mixed model analysis was performed to compare treatment outcomes at the end of treatment. A second linear mixed model analysis was performed to measure between- and within-group effects for up to 24 weeks of follow-up. The Eating Disorder Examination-Questionnaire and clinical impairment assessment were conducted before and after treatment and during follow-up. In addition, dropout rates were assessed in both conditions. During the last 4 weeks of treatment, objective binges reduced from an average of 19 (SD 16) to 3 (SD 5) binges, and 40% (36/90) showed full recovery in the guided self-help CBT-E group. Between-group effect size (Cohen d) was 1.0 for objective binges. At follow-up, after both groups received treatment, there was no longer a difference between the groups. Of the 180 participants, 142 (78.9%) completed treatment. The overall treatment dropout appeared to be associated with gender, level of education, and number of objective binges at baseline but not with treatment condition. This is the first study to investigate the efficacy of guided self-help CBT-E. Guided self-help CBT-E appeared to be an efficacious treatment. This study's findings underscore the international guidelines recommending this type of treatment for binge eating disorder. Netherlands Trial Registry (NTR) NL7994; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7994. RR2-10.1186/s12888-020-02604-1.

Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression

Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH. This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021. Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related. In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services. isrctn.org Identifier: ISRCTN13495752.

The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children

BackgroundGlobally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care.MethodsThis 4-year randomised controlled trial will involve 600 children (aged 9–16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model.DiscussionTreating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group.Trial registrationThis clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Efficacy of computer- and/or internet-based cognitive-behavioral guided self-management for depression in adults: a systematic review and meta-analysis of randomized controlled trials

BackgroundDepression is a worldwide disease. CBT-based self-help treatment allows patients with mild to moderate depression symptoms to improve their depression or to bridge the waiting- or pandemic period until they receive further clinical treatment.ObjectiveThis systematic review and meta-analysis aims to explore the efficacy, acceptability and improvement in quality of life of computer-delivered and/or internet-based CBT self-help interventions with minimal guidance (up to 10 min) for depression. The second aim was to compare the effectiveness of reducing depression symptoms at post-treatment of treatment by the type of minimal guidance: (1) e-mail, (2) telephone calls, (3) e-mail and telephone together, or (4) face-to-face.MethodsThe Cochrane depression, anxiety, and neurosis review group’s specialized register electronic searches, grey literature, reference lists and correspondence were used to search for published and unpublished RCTs that reported efficacy of computer- and/or internet-based CBT self-help treatments for depression with minimal guidance up to 10 min per week. Methodological quality of included studies was evaluated with Cochrane Collaboration tools for assessing risk of bias. The meta-analysis was accomplished using the RevMen software.ResultsIn total, 2809 study abstracts were checked for eligibility. Out of these, 19 studies (21 samples) with a total of 3226 participants were included. The results showed that concerning efficacy, the treatment group is superior to the control group with a medium to large effect size of 0.65. Also, treatment groups with combined guidance by e-mail and telephone calls together had greater effects (SMD -0.76) than groups with other types of minimal guidance (guided by e-mail SMD -0.63; guided face to-face SMD – 0.66; guided by telephone calls SMD -0.49). Findings showed also, that iCBT with minimal guidance had small but statistically significant effect size of 0.28 in improving quality of life. Moreover, there were higher drop-out rates in the treatment condition (RR 1.36) than in the control groups.ConclusionsThe results of this meta-analysis support the efficacy of computer- and/or internet-based CBT self-help programs with minimal weekly guidance up to only 10 min for improving depression symptoms at post-treatment for adults.In addition, the results are pointing towards two practical implications. Firstly, depressed persons can use self-help treatment with minimal guidance at home to improve their symptoms or to bridge the waiting time – or pandemic period – before they receive professional face-to-face treatment. Secondly, it can help clinicians to make the decision about using CBT-based self-help treatments for patients that do not need urgent professional treatment, or to combine it with face-to-face therapy.

Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial

BackgroundThe long-standing view that auditory verbal hallucinations (AVH) or hearing voices is a sign of schizophrenia has been challenged by research demonstrating that they lie on a continuum ranging from normal to pathological experience related to distress and need for care. Hearing voices is more prevalent in adolescence than in later life, and hearing voices during adolescence indicates a risk for severe psychopathology, functional impairments, and suicide later in life. While there is increasing evidence for the efficacy of cognitive behavioral therapy for voices (CBTv) in adults with schizophrenia, research on psychological treatments for youth with distressing voices has been scarce. The aim of the current study is to examine the efficacy of CBTv, delivered using smartphone-based Ecological Momentary Assessment Intervention (EMI) in a transdiagnostic sample of youth.MethodsThis is a superiority randomized controlled trial comparing 8 weeks of CBTv-based EMI in addition to treatment as usual (TAU) versus TAU only. TAU covers both no treatment and any form of psychiatric/psychological treatment. In the EMI condition, participants will be prompted twice a day to complete an EMA survey, and receive one intervention proposal per assessment. One-hundred fifty-four youth aged 14–25 years with distressing voices will be recruited from psychiatric clinics, local private practices, internet forums, and advertisements in print and social media. Before and after the intervention phase, participants will undergo a 9-day EMA. Single-blinded assessments will be conducted at baseline (T0) and at 3-month (T1) and 6-month (T2) follow-up. The primary outcome is the distress dimension of the Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales at T1. Secondary outcomes include perceived hostile intention, power, and dominance of voices, passive, aggressive, and assertive relating to voices, and negative core beliefs about the self.DiscussionAdolescence provides a crucial window of opportunity for early intervention for hearing voices. However, youth are notoriously reluctant help-seekers. This study offers a low-intensity psychological intervention for youth with distressing voices beyond diagnostic boundaries that, using a mobile technology approach, may match the treatment preferences of the generation of “digital natives.”Trial registrationGerman Clinical Trials Register DRKS00026243. Registered on 2 September 2021

A protocol for unguided internet self-help cognitive behaviour therapy for perfectionism in adolescents at-risk of eating disorders

Perfectionism has a strong association with eating disorders, anxiety and depression. Unguided internet cognitive behaviour therapy for perfectionism has demonstrated efficacy in female adolescents without elevated eating disorder symptoms. No research to date has examined unguided internet cognitive behaviour therapy for perfectionism for adolescents with elevated eating disorder symptoms as an indicated prevention for eating disorders and co-occurring symptoms of anxiety and depression. The protocol outlines the plan for a randomised controlled trial of a co-designed, unguided internet cognitive behaviour therapy for perfectionism with female adolescents with elevated symptoms of eating disorders. The intervention will be a 4-week programme compared to a waitlist control. Outcomes on eating disorder symptoms, anxiety and depression will be measured pre and post intervention and follow-up. Trial registrationThis trial was registered on 23 September 2020 with the Australian New Zealand Clinical Trials Registry (ACTRN12620000951954P).

Online Guided Self-help Cognitive Behavioral Therapy With Exposure to Anxiety and Problem Solving in Type 1 Diabetes Mellitus: Case Study.

BackgroundType 1 diabetes mellitus (T1DM) is dependent on self-care to avoid short- and long-term complications. There are several problem areas in diabetes that could be addressed by psychological interventions, such as suboptimal problem-solving strategies and fear of hypoglycemia. There is empirical support for a few psychological interventions, most often cognitive behavioral therapy, with various treatment aims. However, these interventions are largely unavailable in regular diabetes health care. Online guided self-help cognitive behavioral therapy could help achieve greater outreach.ObjectiveWe tested a manualized treatment in the early stage for further development, with the long-term aim to increase access to care. The purpose of this report was to show the potential of this newly developed online intervention by describing 2 illustrative cases.MethodsAn online guided self-help cognitive behavioral therapy protocol featuring problem solving and exposure was developed. The treatment was administered from a secure online platform and lasted for 8 weeks. Case 1 was a male participant. He had a number of diabetes-related complications and was worried about his future. He reported that he had a general idea that he needed to change his lifestyle but found it difficult to get started. Case 2 was a female participant. She had fear of hypoglycemia and unhelpful avoidance behaviors. She kept her blood glucose levels unhealthily high in order to prevent hypoglycemic episodes. Furthermore, she avoided contact with diabetes health care.ResultsThe 2 participants showed clinically significant improvements in their most relevant problem areas. In case 1, the participant’s blood glucose levels reduced, and he was able to establish healthy routines, such as increase physical exercise and decrease overeating. In case 2, the participant’s fear of hypoglycemia greatly decreased, and she was able to confront many of her avoided situations and increase necessary visits to her diabetes clinic. Treatment satisfaction was high, and no adverse events were reported.ConclusionsIt is possible to deliver a cognitive behavioral therapy intervention aimed at problem areas in diabetes online. Problem solving appears to help with problems in everyday routines and lifestyle choices. Exposure to aversive stimuli appears to be a plausible intervention specifically aimed at the fear of hypoglycemia. Larger and controlled studies are needed.

Development of a self-help cognitive behavioral therapy programme for reducing the stigma of stroke survivors: a modified delphi study

ABSTRACT Background Stigma is a common psychological consequence for stroke survivors that aggravates their physical and psychological burden and hinders their rehabilitation. Currently, there are few interventions targeted at the stigma of stroke survivors. Objectives This study reports on the development of a self-help cognitive behavioral therapy (CBT) programme driven by a logical model of stigma in stroke survivors, CBT and the advice of multidomain experts. Methods A logical model of stigma in stroke survivors was derived from a systematic search of the literature and semistructured interviews with 21 patients to identify factors influencing stigma. The item content of the programme was generated based on this logical model in combination with CBT. A modified Delphi process with an expert panel of multidomain experts was used to evaluate and refine the content of the programme. SPSS 20.0 was used for data analysis. Results Seventeen experts accepted the invitation to participate, and all completed two rounds of the Delphi survey. Six sections and 26 items were identified. Consensus was reached among experts that the self-help CBT programme included the following six sections: health education, understanding stigma, cognition change, skills training and self-care, self-acceptance and relapse prevention. Conclusions The self-help CBT programme includes health education and psychological education. This study extends the limited body of research on stroke-related stigma interventions, and the next step is to evaluate its efficacy in trials.

A pilot randomised controlled trial of guided self-help cognitive behaviour therapy for perfectionism: Impact on diagnostic status and comorbidity

Background and objectivesPerfectionism is associated with the development and maintenance of anxiety, mood, and eating disorders. Cognitive behaviour therapy (CBT) results in significant reductions in perfectionism and psychological symptoms however, the majority of studies have not examined clinical samples or impact on diagnostic status and comorbidity. MethodsForty participants with elevated perfectionism, of whom 80% had a range of psychological disorders, were randomised to CBT for perfectionism or waitlist control. ResultsThe treatment group reported significant large effect size reductions in perfectionism measures of personal standards and concern over mistakes (d = 1.1–1.6), dichotomous thinking (d = 1.2), and medium effect size reductions in depression (d = 0.55) and increases in quality of life (d = 0.73), which were maintained at 4 month follow-up. The participants in the treatment group were significantly less likely to present with comorbid psychological disorders at post-treatment than the control group. LimitationsThe sample size was small, and there was no control condition at follow-up. ConclusionsFindings lend further support for CBT for perfectionism as an efficacious transdiagnostic treatment for perfectionism and related psychopathology.

Efficacy of Email-delivered Versus Face-to-face Group Cognitive Behavioral Therapy for Insomnia in Youths: A Randomized Controlled Trial

PurposeThe purpose of the study was to compare the efficacy of group-based therapy (GT) and email-delivered self-help (ESH) cognitive behavioral therapy for insomnia (CBT-I) with the wait-list (WL) control group in youths. MethodsThe study involved an assessor-blind, parallel group randomized controlled trial in youths meeting the diagnostic criteria for insomnia disorder. Participants were randomized to one of the three groups (8-week GT, 8-week ESH, or WL). Participants in all three groups were assessed at baseline and after treatment (week 9 for the WL group). The two treatment groups were additionally assessed at one month and six months after the intervention. Treatment effects were examined using linear mixed models. ResultsA total of 135 youths (mean age: 20.0 ± 2.5 years, female: 67.4%) were recruited. After treatment, both active treatment groups showed significant improvements in insomnia symptoms (GT vs. WL: Cohen's d = −1.03, ESH vs. WL: d = −.63), less presleep arousal (d = −.52 to −1.47), less sleep-related dysfunctional belief (d = −.88 to −1.78), better sleep hygiene practice (d = −.79 to −.84), and improved daytime functioning (d = −.56 to −.96) compared with the WL group. In addition, GT outperformed ESH in improving maladaptive sleep-related beliefs and mood symptoms at post-treatment and 6-month follow-up. A reduction of suicidality with moderate effect size favoring GT emerged at 6-month follow-up. DiscussionOur findings suggested that both group-based and email-delivered CBT-I were effective in treating youth insomnia, but group-based CBT-I showed superior effects on reducing maladaptive beliefs and mood symptoms.