Guided Self-help Intervention Research Articles

Predicting optimal treatment allocation for cognitive analytic-guided self-help versus cognitive behavioural-guided self-help.

Given the ubiquity in routine services of low-intensity guided self-help (GSH) psychological interventions, better patient selection for these brief interventions would be organizationally efficient. This study therefore sought to define who would respond best to two different types of GSH for anxiety to enable better future treatment matching. The study used outcome data from a patient preference trial (N = 209) comparing cognitive analytic therapy-guided self-help (CAT-GSH) with cognitive behavioural therapy-guided self-help (CBT-GSH). Elastic Net regularization and Boruta random forest variable selection methods were applied. Regression models calculated the patient advantage index (PAI) to designate which GSH was likely the most effective for each patient. Outcomes were compared for those receiving their PAI-indicated optimal and non-optimal GSH. Lower baseline depression and anxiety severity predicted better outcomes for both types of GSH. Patient preference status was not associated with outcome during either GSH. Sixty-three % received their model indicating optimal GSH and these had significantly higher rates of reliable and clinically significant reductions in anxiety at both post-treatment (35.9% vs. 16.6%) and follow-up (36.6% vs. 19.2%). No single patient with a large PAI had a reliable and clinically significant reduction in anxiety at post-treatment or follow-up when they did not receive their optimal GSH. Treatment matching algorithms have the potential to support evidenced-based treatment selection for GSH. Treatment selection and supporting patient choice needs to be integrated. Future research needs to investigate the use of the PAI for GSH treatment matching, but with larger and more balanced samples.

Correction to: Empowerment-Led Guided Self-Help Intervention for Symptom Burden in Breast Cancer Women Treated With Ovarian Function Suppression: A Randomized Trial Protocol

Correction to: Empowerment-Led Guided Self-Help Intervention for Symptom Burden in Breast Cancer Women Treated With Ovarian Function Suppression: A Randomized Trial Protocol

Empowerment-Led Guided Self-Help Intervention for Symptom Burden in Breast Cancer Women Treated With Ovarian Function Suppression: A Randomized Trial Protocol.

Ovarian function suppression (OFS) treatment causes breast cancer patients' estrogens to fall rapidly to postmenopausal levels, and the 5-year treatment duration and 28-day treatment cycles place a heavy physical and psychological symptom burden on them, which in turn directly or indirectly affects the survival benefit. Managing symptom burden early in treatment is critical, but OFS-related studies have yet to be seen. Self-management is essential for patients' symptom burden. However, self-help management is hampered by patients' lack of knowledge, skills, motivation, etc. Guided self-help intervention (GSH) provides a feasible approach. Empowerment theory is a promising theoretical framework to guide self-management. A prospective two-arm parallel randomized controlled single-blind clinical trial will be conducted to investigate the effect of symptom burden GSH based on empowerment theory in breast cancer patients in the early stages of OFS treatment. A block randomization method is used to allocate 144 patients to either the control or intervention group. The program is conducted according to the OFS return-to-hospital treatment cycle. The intervention group will receive a total of two rounds and five sessions of empowering GSH, lasting at least 15 weeks in total; the control group will receive only usual nursing care. Symptom burden and related metrics will be assessed at baseline and 1, 3, and 6 months after OFS treatment, and changes between and within groups will be explored. This paper adhered to the SPIRIT and CONSORT guidelines. These results will help to validate the GSH in symptom burden management for breast cancer patients in OFS treatment early stages. It enriches its symptom burden management research and may provide implications for the whole cycle of OFS treatment patients.

Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE.

Social anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet. This study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents. A total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment. Recruitment is ongoing; initial results are expected in 2024. Results are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents. ClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102. DERR1-10.2196/44346.

Adapting an online guided self-help intervention for the management of binge eating in adults with type 2 diabetes: The POSE-D study.

People with type 2 diabetes (T2D) are more likely to experience binge eating than the general population, which may interfere with their diabetes management. Guided self-help (GSH) is the recommended treatment for binge-eating disorder, but there is currently a lack of evidenced treatment for binge eating in individuals living with T2D. The aims of the current study were to adapt an existing evidence-based GSH intervention using the principles of co-design to make it available online, suitable for remote delivery to address binge eating specifically in adults living with T2D. The Working to Overcome Eating Difficulties GSH intervention comprises online GSH materials presented in seven sections delivered over 12 weeks, supported by a trained Guide. In order to adapt the intervention, we held four collaboration workshops with three expert patients recruited from diabetes support groups, eight healthcare professionals and an expert consensus group. We used thematic analysis to make sense of the data. The main themes included; keeping the GSH material generic, adapting Sam the central character, tailoring the dietary advice and eating diary. The length of Guidance sessions was increased to 60 min, and Guide training was focussed around working with people with diabetes.

Prevalence, Distribution and Attributable Risks of Cannabis Use in Young Adults with Generalised Anxiety Disorder at a University in Botswana

Worldwide, cannabis is the most commonly used drug after tobacco and alcohol, especially among young adults. In Africa, cannabis use is often associated with mental health problems. However, few studies have been conducted to assess which mental health problems are linked to cannabis use, particularly among young adults. This study examined the prevalence, distribution and risks of cannabis use attributed to generalised anxiety disorders. Data from 615 young adults (Mean age = 22.15, ±2.55, 18 – 25; 60.2% female) were used to compute the prevalence and distribution of cannabis use and binary logistic regression models fitted to quantify the risk of using cannabis attributed to different levels of anxiety severity. Of the 615 respondents, 13.8%, 20.4% and 31.7% reported using cannabis in the past month, the past year and lifetime, respectively. Similarly, 11.2% were hazardous users and 5.2% had possible cannabis use disorders. The odds of using cannabis varied with the severity of anxiety symptoms. Compared to those with minimal anxiety problems, the risks of using cannabis ranged from 2.61 (95% Confidence Intervals (CI) 1.65-4.93) to 3.72 (95% CI: 2.10-6.61) for mild anxiety and from 3.68 (95% CI: 2.08 – 6.98) to 6.32 (95% CI: 2.40-16.64) for severe anxiety. Interventions to reduce cannabis use and its concomitant long-term negative consequences should target reducing anxiety problems among young adults. Practitioners should prioritise mental health literacy and programmes such as relaxation techniques and guided selfhelp interventions, which are known to be cheap, effective, and efficient in alleviating anxiety problems.

Supplemental Material for Psychological Flexibility in South Sudanese Female Refugees in Uganda as a Mechanism for Change Within a Guided Self-Help Intervention

Supplemental Material for Psychological Flexibility in South Sudanese Female Refugees in Uganda as a Mechanism for Change Within a Guided Self-Help Intervention

Supporting Weight Management during COVID-19: A Randomized Controlled Trial of a Web-Based, ACT-Based, Guided Self-Help Intervention

Introduction: Adults with overweight and obesity are vulnerable to weight gain and mental health deterioration during the COVID-19 pandemic. We developed a web-based, guided self-help intervention based on Acceptance and Commitment Therapy (ACT) that aims to support adults with overweight and obesity to prevent weight gain by helping them to manage their eating behaviours, be more physically active, and protect their emotional wellbeing (“SWiM-C”). SWiM-C is a guided self-help programme using non-specialist guides to enhance scalability and population reach while minimizing cost. This study evaluated the effect of SWiM-C on bodyweight, eating behaviour, physical activity, and mental wellbeing in adults with overweight and obesity over 4 months during the COVID-19 pandemic in the UK. Methods: We randomized adults (BMI ≥25 kg/m²) to SWiM-C or to a wait-list standard advice group. Participants completed outcome assessments online at baseline and 4 months. The primary outcome was self-measured weight; secondary outcomes were eating behaviour, physical activity, experiential avoidance/psychological flexibility, depression, anxiety, stress, and wellbeing. We estimated differences between study groups in change in outcomes from baseline to 4 months using linear regression, adjusted for outcome at baseline and the randomization stratifiers (BMI, sex). The trial was pre-registered (ISRCTN12107048). Results: 486 participants were assessed for eligibility; 388 participants were randomized (196 standard advice, 192 SWiM-C), and 324 were analysed. The adjusted difference in weight between SWiM-C and standard advice was −0.60 kg (−1.67 to 0.47, p = 0.27). SWiM-C led to improvements in uncontrolled eating (−3.61 [−5.94 to −1.28]), cognitive restraint (5.28 [2.81–7.75]), experiential avoidance (−3.39 [−5.55 to −1.23]), and wellbeing (0.13 [0.07–0.18]). Conclusions: SWiM-C improved several psychological determinants of successful weight management and had a protective effect on wellbeing during the pandemic. However, differences in weight and some other outcomes were compatible with no effect of the intervention, suggesting further refinement of the intervention is needed.

The experience of autistic adults accessing adapted cognitive behaviour therapy: ADEPT (Autism Depression Trial) qualitative evaluation

BackgroundHigh rates of depression are frequently reported in autistic adults. There have been no randomised trials investigating low-intensity psychological interventions for mild-moderate depression adapted for autistic adults. MethodThis qualitative evaluation investigated the acceptability of the ADEPT pilot randomised controlled trial (RCT) design and guided self-help intervention. Participants (autistic adults with a diagnosis of depression (PHQ-9 score ≥ 10)) were randomised to Guided Self-Help (GSH): low intensity psychological intervention based on Behavioural Activation adapted for autistic adults, or Treatment as Usual (TAU). 21 trial participants (14 GSH and 7 TAU), and 5 low intensity psychological therapists or ‘coaches’ were interviewed, and transcripts analysed thematically. ResultsAll participants and coaches welcomed an intervention for depression adapted for autistic adults due to current lack of provision in mainstream services. Interviews highlighted participants' preference for GSH over TAU. Dissatisfaction with prior experience of TAU was identified as a potential driver for differential attrition from the TAU arm. Participants who received GSH appreciated the coaches having a good understanding of autistic adults and were positive towards the aim and structure of the GSH intervention. Suggested improvements include more regularly checking progress with therapy goals. ConclusionsA full scale RCT to evaluate the effectiveness of this intervention is now warranted. Future trial study design needs to address potential for differential rate of participant recruitment and attrition between the treatment and comparison groups due to negative prior experience of TAU.

Effectiveness of a Digital Cognitive Behavior Therapy–Guided Self-Help Intervention for Eating Disorders in College Women

Eating disorders (EDs) are common, serious psychiatric disorders on college campuses, yet most affected individuals do not receive treatment. Digital interventions have the potential to bridge this gap. To determine whether a coached, digital, cognitive behavior therapy (CBT) intervention improves outcomes for college women with EDs compared with referral to usual care. This cluster randomized trial was conducted from 2014 to 2018 at 27 US universities. Women with binge-purge EDs (with both threshold and subthreshold presentations) were recruited from enrolled universities. The 690 participants were followed up for up to 2 years after the intervention. Data analysis was performed from February to September 2019. Universities were randomized to the intervention, Student Bodies-Eating Disorders, a digital CBT-guided self-help program, or to referral to usual care. The main outcome was change in overall ED psychopathology. Secondary outcomes were abstinence from binge eating and compensatory behaviors, as well as ED behavior frequencies, depression, anxiety, clinical impairment, academic impairment, and realized treatment access. A total of 690 women with EDs (mean [SD] age, 22.12 [4.85] years; 414 [60.0%] White; 120 [17.4%] Hispanic; 512 [74.2%] undergraduates) were included in the analyses. For ED psychopathology, there was a significantly greater reduction in the intervention group compared with the control group at the postintervention assessment (β [SE], -0.44 [0.10]; d = -0.40; t1387 = -4.23; P < .001), as well as over the follow-up period (β [SE], -0.39 [0.12]; d = -0.35; t1387 = -3.30; P < .001). There was not a significant difference in abstinence from any ED behaviors at the postintervention assessment (odds ratio, 1.48; 95% CI, 0.48-4.62; P = .50) or at follow-up (odds ratio, 1.51; 95% CI, 0.63-3.58; P = .36). Compared with the control group, the intervention group had significantly greater reductions in binge eating (rate ratio, 0.82; 95% CI, 0.70-0.96; P = .02), compensatory behaviors (rate ratio, 0.68; 95% CI, 0.54-0.86; P < .001), depression (β [SE], -1.34 [0.53]; d = -0.22; t1387 = -2.52; P = .01), and clinical impairment (β [SE], -2.33 [0.94]; d = -0.21; t1387 = -2.49; P = .01) at the postintervention assessment, with these gains sustained through follow-up for all outcomes except binge eating. Groups did not differ in terms of academic impairment. The majority of intervention participants (318 of 385 participants [83%]) began the intervention, whereas only 28% of control participants (76 of 271 participants with follow-up data available) sought treatment for their ED (odds ratio, 12.36; 95% CI, 8.73-17.51; P < .001). In this cluster randomized clinical trial comparing a coached, digital CBT intervention with referral to usual care, the intervention was effective in reducing ED psychopathology, compensatory behaviors, depression, and clinical impairment through long-term follow-up, as well as realizing treatment access. No difference was found between the intervention and control groups for abstinence for all ED behaviors or academic impairment. Given its scalability, a coached, digital, CBT intervention for college women with EDs has the potential to address the wide treatment gap for these disorders. ClinicalTrials.gov Identifier: NCT02076464.

4016 Combined Eating Disorder and Weight-Loss Online Guided-Self Help Intervention: Updated Results from an Ongoing Pilot Study

OBJECTIVES/GOALS: Aims 1&amp;2: Develop (1) and implement (2) online, guided self-help intervention for ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance at end of treatment and 6-months. METHODS/STUDY POPULATION: N = 60 college students meeting criteria (clinical/sub-clinical binge-type ED with BMI &gt; 25) will complete a baseline survey and then will be randomized into a condition. Students in the intervention group (n = 30) will be offered 8 weeks of an online, guided self-help intervention for ED and WL. Students in the control group (n = 30) will receive an email message to seek support from Student Health Services. All participants will receive follow-ups 9 weeks and 6 months after baseline. Data analysis will compare Eating Disorder Examination Questionnaire (EDE-Q) scores and WL (change in BMI) at all three time-points. Group comparisons will be assessed via two-way mixed-model ANOVA. RESULTS/ANTICIPATED RESULTS: Recruitment is still ongoing. Data collected by the time of the conference will be presented on the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these commonly comorbid conditions concurrently. Thus, this pilot study will examine the effectiveness of combined programs to breach this treatment gap.

3098 Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention: A Pilot Study

OBJECTIVES/SPECIFIC AIMS: Among college students with binge-type eating disorders who are overweight (BMI &gt;25), does use of an online, guided self-help program for EDs combined with healthy weight-loss (WL) methods lead to reductions in ED symptoms and weight loss compared to controls referred to standard in-person treatment (Student Health Services)? Aim 1: Develop online, guided self-help program for intervention of ED psychopathology and weight reduction. Aim 2: Implement online, guided self-help program for intervention of ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance. METHODS/STUDY POPULATION: Up to N=60 college students who meet the criteria (clinical or sub-clinical binge-type ED and have a BMI &gt; 25) and elect to participate will complete a baseline survey to enroll in the study, then will be randomized into a condition. Students in the intervention group (n=30) will be offered 8 weeks of online, guided self-help intervention for ED and WL. Students in the control group (n=30) will receive an email message encouraging them to seek support from Student Health Services for their WL and eating behavior concerns, along with appropriate contact information. All participants will receive follow-up 9 weeks after completing initial baseline, and a final follow-up survey 6-months after completing their baseline. RESULTS/ANTICIPATED RESULTS: Analysis of intervention and control groups will compare average Eating Disorder Examination Questionnaire (EDEQ) scores and WL (change in BMI) at the end of the intervention (9 weeks) and at 6-month follow-up. Group comparisons will be assessed via two-way mixed model ANOVA. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these conditions together. Thus, the use of online intervention for ED psychopathology and WL in individuals with clinical and sub-clinical EDs is the next step. The goal of this study is to implement a program to reduce weight and shape concerns, reduce disordered eating symptoms, such as bingeing, and compensatory behaviors associated with binge-type EDs, while also reducing weight for individuals with EDs and comorbid overweight/obesity. This project will pilot an online, guided self-help ED intervention that offers cognitive behavioral based tools to improve ED symptoms in college students, while also teaching the healthy methods of behavioral WL, for students with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity in order to examine effectiveness of the program compared to referral to Student Health Services for ED and WL concerns. Furthermore, the use of an online, guided self-help intervention is more scalable and can circumvent many of the barriers to traditional in-person treatment.

Binge-eating disorder treatment goes online \u2013 feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group

BackgroundBinge-eating disorder (BED) is characterized by recurrent episodes of loss of control over eating and is related to a higher prevalence of other mental disorders and somatic consequences associated with overweight and obesity. In community-based samples, 2–4% of women and 1–3% men are diagnosed with BED. Psychotherapeutic interventions focusing on maintenance factors of disturbed eating behavior have proven to be effective. However, treatment access is limited for a considerable number of patients with BED. A lack of specialized institutions and treatment resources, but also long distances to treatment facilities for people living in remote or rural areas are often causes of insufficient care. Internet-based guided self-help (GSH) programs have the potential to fill this gap.MethodsThis project aims to develop and evaluate an Internet-based treatment for BED derived from an evidence-based manualized cognitive behavioral therapy (CBT). The primary goal is to test feasibility and suitability of the Internet-based program and to evaluate the treatment outcome in comparison to a pure and a placebo-inspired waitlist control group (i.e. reduction of binge-eating episodes and eating disorder pathology as primary outcome variables). In total, 60 women and men aged 18–70 years with a BED diagnosis will be recruited. The Internet-based GSH treatment comprises eight sessions followed by three booster sessions. The placebo-inspired waitlist control group receives weekly messages containing information increasing positive expectations regarding the treatment effects during the four-week waiting period. The pure waitlist control group receives weekly messages simply asking patients to fill in a short questionnaire.DiscussionThe access to evidence-based treatments for BED might be made easier using an Internet-based GSH approach. The present study protocol presents a randomized controlled trial. As well as evaluating the suitability and efficacy of the Internet-based GSH treatment, there will also be a prelimarily investigation on the influence of positive expectations (placebo) for a therapeutic intervention on core symptoms.Trial registrationGerman Clinical Trials Register, DRKS00012355. Registered on 14 September 2017.

Supplemental Material for A Mobile App for Social Anxiety Disorder: A Three-Arm Randomized Controlled Trial Comparing Mobile and PC-Based Guided Self-Help Interventions

Supplemental Material for A Mobile App for Social Anxiety Disorder: A Three-Arm Randomized Controlled Trial Comparing Mobile and PC-Based Guided Self-Help Interventions

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P < .05) effects of the intervention on physical and mental functioning and treatment control. The self-help intervention was acceptable to patients and allowed them to better understand and self-manage chronic orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Effect of a Web-Based Guided Self-Help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression

Importance Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD. Objective To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD. Design, Setting, and Participants Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). Interventions All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204). Main Outcomes and Measures The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Results Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6). Conclusions and Relevance Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer. Trial Registration German Clinical Trial Registry Identifier:DRK4709

Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care

Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care

Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial.

Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD. To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD. Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204). The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6). Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer. German Clinical Trial Registry Identifier: DRKS00004709.

Effectiveness of a Web-Based Guided Self-help Intervention for Outpatients With a Depressive Disorder: Short-term Results From a Randomized Controlled Trial.

BackgroundResearch has convincingly demonstrated that symptoms of depression can be reduced through guided Internet-based interventions. However, most of those studies recruited people form the general population. There is insufficient evidence for the effectiveness when delivered in routine clinical practice in outpatient clinics.ObjectiveThe objective of this randomized controlled trial was to study patients with a depressive disorder (as defined by the Diagnostic and Statistical Manual of Disorders, fourth edition), as assessed by trained interviewers with the Composite International Diagnostic Interview, who registered for treatment at an outpatient mental health clinic. We aimed to examine the effectiveness of guided Internet-based self-help before starting face-to-face treatment.MethodsWe recruited 269 outpatients, aged between 18 and 79 years, from outpatient clinics and randomly allocated them to Internet-based problem solving therapy (n=136), with weekly student support, or to a control condition, who remained on the waitlist with a self-help booklet (control group; n=133). Participants in both conditions were allowed to take up face-to-face treatment at the outpatient clinics afterward. We measured the primary outcome, depressive symptoms, by Center for Epidemiological Studies Depression scale (CES-D). Secondary outcome measures were the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), Insomnia Severity Index questionnaire (ISI), and EuroQol visual analog scale (EQ-5D VAS). All outcomes were assessed by telephone at posttest (8 weeks after baseline).ResultsPosttest measures were completed by 184 (68.4%) participants. We found a moderate to large within-group effect size for both the intervention (d=0.75) and the control (d=0.69) group. However, the between-group effect size was very small (d=0.07), and regression analysis on posttreatment CES-D scores revealed no significant differences between the groups (b=1.134, 95% CI –2.495 to 4.763). The per-protocol analysis (≥4 sessions completed) results were also not significant (b=1.154, 95% CI –1.978 to 7.637). Between-group differences were small and not significant for all secondary outcomes. Adherence to the intervention was low. Only 36% (49/136) received an adequate dosage of the intervention (≥4 of 5 sessions). The overall treatment satisfaction was moderate.ConclusionsInternet-based problem solving therapy is not more effective in reducing symptoms of depression than receiving an unguided self-help book during the waitlist period at outpatient mental health clinics. The effect sizes are much smaller than those found in earlier research in the general population, and the low rates of adherence indicate that the acceptability of the intervention at this stage of treatment for depressed outpatients is low. However, taking into account that there is much evidence for the efficacy of Internet-based treatments, it is too early to draw firm conclusions about the effectiveness of these treatments in outpatient clinics as a whole.Trial RegistrationNetherlands Trial Register NTR2824; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2824 (Archived by WebCite at http://www.webcitation/ 6g3WEuiqH)

The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial.

BackgroundGeneralized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking.ObjectiveTo evaluate the feasibility, acceptability, and efficacy of Internet-based, or “online,” cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population.MethodsStudents will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA.ResultsThe study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015.ConclusionsThis trial will be the first to evaluate the use of Internet-based CBT programs compared with a wait-list control group for the treatment of GAD among students in Indian universities. If effective, these programs have the potential to reduce the mental health care treatment gap by providing readily accessible, private, and cost-effective evidence-based care to students with GAD who do not currently receive the treatment they need.Trial RegistrationClinicalTrials.gov NCT02410265 http://clinicaltrials.gov/ct2/show/NCT02410265 (Archived by WebCite at http://www.webcitation.org/6ddqH6Rbt).