Digital Cognitive Behavioral Therapy Research Articles

Digital cognitive behavioral therapy for insomnia for people with comorbid psychological distress: A large scale randomized controlled trial

Study objectivesTo examine if comorbid anxiety and depression symptoms (psychological distress) moderate intervention effect in participants receiving digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in a large-scale randomized controlled trial (RCT), compared to a patient education (PE) control condition. Further, we investigate if dCBT-I reduced levels of psychological distress for those with insomnia and comorbid psychological distress. Methods1721 participants with insomnia completed online assessments of sleep, fatigue and psychological distress, at baseline and at nine-week follow-up. Primary outcome was Insomnia Severity Index (ISI), and secondary outcomes included self-reported sleep (diary), cognition, fatigue, and psychological distress. Participants with psychological distress (HADS>16) were separated from participants without psychological distress. Linear mixed models in SPSS were conducted to test the effects of the intervention. ResultsAt nine-week follow-up we found no difference in effect of the intervention between those who had comorbid psychological distress vs. those without psychological distress in terms of insomnia severity (p = 0.552) and fatigue (p = 0.744). Both groups had large effect size improvements on insomnia severity (p < 0.001=), small to medium (Cohen d < 0.08) improvements on fatigue (p < 0.01=) and sleep efficiency (p < 0.001), and small improvement on other sleep diary measures, compared to their respective control group. The psychological distress group showed a small, but statistically significant decrease in psychological distress (d = 0.2, p < 0.05) with dCBT-I compared to PE. ConclusiondCBT-I is a viable treatment for Insomnia also for those who have comorbid psychological distress.

Structural brain changes associated with cocaine use and digital cognitive behavioral therapy in cocaine use disorder treatment

BackgroundFew studies have investigated changes in brain structure and function associated with recovery from cocaine use disorder (CUD), and fewer still have identified brain changes associated with specific CUD treatments, which could inform treatment development and optimization. MethodsIn this longitudinal study, T1-weighted magnetic resonance imaging scans were acquired from 41 methadone-maintained individuals with CUD (15 women) at the beginning of and after 12 weeks of outpatient treatment. As part of a larger randomized controlled trial, these participants were randomly assigned to receive (or not) computer-based training for cognitive behavioral therapy (CBT4CBT), and galantamine (or placebo). ResultsIrrespective of treatment condition, whole-brain voxel-based morphometry analyses revealed a significant decrease in right caudate body, bilateral cerebellum, and right middle temporal gyrus gray matter volume (GMV) at post-treatment relative to the start of treatment. Subsequent region of interest analyses found that greater reductions in right caudate and bilateral cerebellar GMV were associated with higher relative and absolute levels of cocaine use during treatment, respectively. Participants who completed more CBT4CBT modules had a greater reduction in right middle temporal gyrus GMV. ConclusionsThese results extend previous findings regarding changes in caudate and cerebellar GMV as a function of cocaine use and provide the first evidence of a change in brain structure as a function of engagement in digital CBT for addiction. These data suggest a novel potential mechanism underlying how CBT4CBT and CBT more broadly may exert therapeutic effects on substance-use-related behaviors through brain regions implicated in semantic knowledge.

Is cognitive behavioral therapy for insomnia (CBTI) more cost-effective? New-perspective on economic evaluations: a systematic review and meta-analysis.

To investigate the cost-effectiveness of cognitive behavioral therapy for insomnia (CBTI), with an additional focus on digital cognitive behavioral therapy for insomnia (dCBTI) in adults with insomnia. We searched eight electronic databases for economic evaluations of CBTI: PubMed, Scopus, Web of Science, psycINFO, Cochrane, Library, CINAHL, ProQuest and National Health Service Economic Evaluation Database. Meta-analyses were performed to investigate the effects and costs between CBTI and control groups (no treatment, other treatments included hygiene education and treatment as usual). Subgroup analyses for dCBTI were conducted. Twelve randomized controlled trails studies between 2004 and 2023 were included in our systematic review and meta-analyses. The incremental cost-utility ratios and incremental cost-effectiveness ratios showed that the CBTI and dCBTI groups were more cost-effective than controls, from healthcare perspective and societal perspective, respectively. Compared to controls, CBTI demonstrated significantly better efficacy within 12 months. Healthcare costs were significantly higher in the CBTI groups compared to the controls within 6 months but there was no difference at 12 months. Additionally, dCBTI was associated with significantly lower presenteeism costs compared to controls at 6 months. Our findings suggest that CBTI is more cost-effective than other treatments or no treatment for adults with insomnia. It may bring more economic benefits in the long-term, especially in long-lasting efficacy and costs reduction. In addition, dCBTI is one of the cost-effective options for insomnia.

Evaluation of a digital Cognitive Behavioural Therapy programme for prison residents with histories of substance misuse (“Breaking Free”): Comparison of delivery models employed in the United Kingdom and the United States

Substance misuse is a criminogenic risk factor—however, substance-involved prison residents may have limited access to support and services that might be able to help them overcome their substance misuse. Research around the efficacy of the “Breaking Free” digital Cognitive Behavioural Therapy programme for substance-involved prison residents demonstrates that this digital technology may overcome barriers to support. Breaking Free is the first digital programme for substance misuse that has been implemented in prisons. In the United Kingdom (U.K.) the programme is delivered via secure desktop and laptop computers in staff-facilitated group sessions, and in the United States (U.S.) is delivered via individual secure tablets that prison residents can access independently, without staff support. This study compares U.K. and U.S. prison residents who have engaged with Breaking Free on a number of baseline measures (sociodemographic factors, types of problem substances reported, clinical complexity, and criminogenic risk factors). The delivery models employed in these two jurisdictions are compared in relation to their associations with prison residents’ engagement with the programme and the clinical outcomes experienced. Differences between U.K. and U.S. prison residents in baseline clinical and psychosocial factors were identified, including greater clinical complexity in the U.K. group. U.K. prison residents, who were supported by staff when using Breaking Free, demonstrated higher levels of engagement with the programme than U.S. prison residents who were not supported by staff. The different delivery models employed in the United Kingdom and United States appeared to be associated with group differences in clinical outcomes. Guidance for the optimal implementation of Breaking Free, based on findings from this study, is provided. Further analyses will explore how the different approaches to the delivery of Breaking Free might interact with the differences in prison resident characteristics identified in this study (sociodemographic, clinical and criminogenic), in order to influence prison resident engagement with the programme and clinical outcomes.

0442 A Qualitative Assessment of Digital Cognitive Behavioral Therapy for Insomnia in Heavy Drinkers with Insomnia

0442 A Qualitative Assessment of Digital Cognitive Behavioral Therapy for Insomnia in Heavy Drinkers with Insomnia

Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: A randomised-controlled pilot trial.

Insomnia is a primary symptom of shift work disorder, yet it remains undertreated. This randomised-controlled pilot trial examined the efficacy of a digital, guided cognitive behavioural therapy for insomnia adapted to shift work (SleepCare) in nurses with shift work disorder. The hypothesis was that SleepCare reduces insomnia severity compared with a waitlist control condition. A total of 46 unmedicated nurses suffering from shift work disorder with insomnia (age: 39.7 ± 12.1 years; 80.4% female) were randomised to the SleepCare group or the waitlist control group. The primary outcome measure was the Insomnia Severity Index. Other questionnaires on sleep, mental health and occupational functioning, sleep diary data and actigraphy data were analysed as secondary outcomes. Assessments were conducted before (T0), after the intervention/waitlist period (T1), and 6 months after treatment completion (T2). The SleepCare group showed a significant reduction in insomnia severity from T0 to T1 compared with the control condition (β = -4.73, SE = 1.12, p < 0.001). Significant improvements were observed in sleepiness, dysfunctional beliefs about sleep, pre-sleep arousal, sleep effort, self-reported sleep efficiency and sleep onset latency. No significant effect was found in actigraphy data. Depressive and anxiety symptoms, cognitive irritation and work ability improved significantly. Overall, satisfaction and engagement with the intervention was high. SleepCare improved insomnia severity, sleep, mental health and occupational functioning. This is the first randomised-controlled trial investigating the efficacy of digital cognitive behavioural therapy for insomnia in a population suffering from shift work disorder with insomnia. Future research should further explore these effects with larger sample sizes and active control conditions.

Effect of high-risk sleep apnea on treatment-response to a tailored digital cognitive behavioral therapy for insomnia program: a quasi-experimental trial

Effect of high-risk sleep apnea on treatment-response to a tailored digital cognitive behavioral therapy for insomnia program: a quasi-experimental trial

Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life-Results from the Menopause after Cancer (Mac) Study.

Vasomotor symptoms (VMSs) associated with menopause represent a significant challenge for many patients after cancer treatment, particularly if conventional menopausal hormone therapy (MHT) is contraindicated. The Menopause after Cancer (MAC) Study (NCT04766229) was a single-arm phase II trial examining the impact of a composite intervention consisting of (1) the use of non-hormonal pharmacotherapy to manage VMS, (2) digital cognitive behavioral therapy for insomnia (dCBT-I) using Sleepio (Big Health), (3) self-management strategies for VMS delivered via the myPatientSpace mobile application and (4) nomination of an additional support person/partner on quality of life (QoL) in women with moderate-to-severe VMS after cancer. The primary outcome was a change in cancer-specific global QoL assessed by the EORTC QLC C-30 v3 at 6 months. Secondary outcomes included the frequency of VMS, the bother/interference of VMS and insomnia symptoms. In total, 204 women (82% previous breast cancer) with a median age of 49 years (range 28-66) were recruited. A total of 120 women completed the protocol. Global QoL scores increased from 62.2 (95%CI 58.6-65.4) to 70.4 (95%CI 67.1-73.8) at 6 months (p < 0.001) in the intention to treatment (ITT) cohort (n = 204) and from 62 (95%CI 58.6-65.4) to 70.4 (95%CI 67.1-73.8) at 6 months (p < 0.001) in the per-protocol (PP) cohort (n = 120). At least 50% reductions were noticed in the frequency of VMS as well as the degree of bother/interference of VMS at six months. The prevalence of insomnia reduced from 93.1% at the baseline to 45.2% at 6 months (p < 0.001). The Sleep Condition Indicator increased from 8.5 (SEM 0.4) to 17.3 (SEM 0.5) (p < 0.0005) in the ITT cohort and 7.9 (SEM 0.4) to 17.3 (SEM 0.5) (p < 0.001) in the PP cohort. A targeted composite intervention improves the quality of life for cancer patients with frequent and bothersome vasomotor symptoms with additional benefits on frequency, the bother/interference of VMS and insomnia symptoms.

A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. NCT04535778.

Clinically guided digital Cognitive Behavioural Therapy for insomnia (CBTi) in patients with COMISA: a case-control pilot study with focus on mental health and cardiometabolic risk factors

Clinically guided digital Cognitive Behavioural Therapy for insomnia (CBTi) in patients with COMISA: a case-control pilot study with focus on mental health and cardiometabolic risk factors

Efficacy of digital cognitive behavioural therapy for insomnia: a randomised controlled trial using a new App that tracks sleep continuously using HRV

Efficacy of digital cognitive behavioural therapy for insomnia: a randomised controlled trial using a new App that tracks sleep continuously using HRV

Digital cognitive behavioural therapy for patients with insomnia and depression: A systematic review and meta-analysis.

Sleep problems are common among those with depression, and there is increasing evidence that sleep problems should be addressed during treatment simultaneously rather than treating depression alone. The first-line treatment for insomnia is cognitive behavioural therapy for insomnia (CBT-I), due to a lack of well-trained therapists and patient time constraints (travelling, work), CBT-I has not been popularized. The development of digital cognitive behavioural therapy for insomnia (dCBT-I) is making the treatment more accessible. Interventions for dCBT-I were significantly better than other control conditions in both reducing insomnia and improving depression in patients with depression and insomnia comorbidities. The effect was found to be related to the duration of the intervention and the severity of insomnia before the intervention and therapist-involved dCBT-I has less shedding than self-help. It's important for mental health practitioners to realize that insomnia in depressed people needs to be treated. Future trials may explore the effectiveness of therapist-guided dCBT-I in depressed populations and analyse the cost-effectiveness of this treatment. Aim The aim of the study was to systematically identify and synthesize the evidence for the effectiveness of digital cognitive behavioural therapy in insomnia with comorbid depression. Design Systematic review and metaanalysis. Methods A search was conducted on five English and four non-English databases from the inception of the databases to November 2023. This review adhered to the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-analysis Statement 2020 and the included studies were evaluated using version 2 of the Cochrane risk of bias tool. This review examined sleep-related outcomes, including insomnia severity and sleep diaries, along with psychological outcomes, such as depression. We conducted a meta-analysis of each outcome using a random effects model. Heterogeneity was assessed by the I2 statistic. Results A total of seven articles with 1864 participants were included in this review. The results showed that the digital cognitive behavioural therapy group demonstrated a statistically significant amelioration in the severity of insomnia symptoms, as well as a reduction in depressive symptomatology compared with the control groups. The post-intervention effect was found to be related to the duration of the intervention and the severity of insomnia before the intervention. Conclusions Digital cognitive behavioural therapy for insomnia application in patients with depression and insomnia was demonstrated to be effective, less time-consuming and more accessible. Relevance to Clinical Practice We may consider incorporating nurses into treatment plans and conducting nurse-led interventions in specific programs. In the future, nurses may be able to provide exclusive digital behavioural therapy for insomnia to patients with depression to achieve greater effectiveness.

Effectiveness-implementation hybrid trial of Spanish language, digital cognitive-behavioral therapy (dCBT) intervention for depression and anxiety – protocol for the SUPERA (SUpport from PEeRs to expand Access) study

BackgroundLimited English Proficiency (LEP) Latinxs experience a longer duration of untreated depression and anxiety. LEP Latinxs have difficulty accessing mental healthcare due to insufficient Spanish-speaking behavioral/mental health clinicians to meet demand. These under-resourced healthcare systems are less likely to be the site for the implementation of innovations. Digital interventions can provide an effective option for overcoming these barriers; yet, when digital evidence-based treatments are available, uptake and engagement is often low. This manuscript presents the protocol for the SUPERA (SUpport from PEeRs to expand Access) study which will evaluate the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (i.e., SilverCloud) in safety-net primary care clinics for LEP Latinx patients with depression or anxiety. MethodsWe will conduct an effectiveness-implementation hybrid trial (Type 2) design comparing engagement and clinical outcomes in two modalities of dCBT delivery (peer-supported vs. unsupported). We will also compare provider-level outreach (using a clinic patient registry) versus inreach (traditional provider referral) to compare rates of initiation, completion, and cost. Participants will be 426 LEP Latinx adults ≥18 years of age, PHQ-9 ≥ 10 or GAD-7 ≥ 8, with access to the internet via smartphone, and not currently receiving individual psychotherapy. We will collect baseline, post-intervention (8 weeks), and follow up (3 months) data. ConclusionThe long-term goal of this research is to aid in the implementation of digital mental health interventions that can be sustainably implemented in low-resourced settings, while reducing the reliance on professionals, overcoming workforce deficits, and increasing relevance for diverse populations.

CETP and APOA2 polymorphisms are associated with weight loss and healthy eating behavior changes in response to digital lifestyle modifications

Response to digital healthcare lifestyle modifications is highly divergent. This study aimed to examine the association between single nucleotide polymorphism (SNP) genotypes and clinical efficacy of a digital healthcare lifestyle modification. We genotyped 97 obesity-related SNPs from 45 participants aged 18–39 years, who underwent lifestyle modification via digital cognitive behavioral therapy for obesity for 8 weeks. Anthropometric, eating behavior phenotypes, and psychological measures were analyzed before and after the intervention to identify their clinical efficacy. CETP (rs9939224) SNP significantly predict “super-responders” with greater body mass index (BMI) reduction (p = 0.028; GG − 2.91%, GT − 9.94%), while APOA2 (rs5082) appeared to have some potential for predicting “poor-responders” with lower BMI reduction (p = 0.005; AA − 6.17%, AG + 2.05%, and GG + 5.11%). These SNPs was also associated with significant differences in eating behavior changes, healthy diet proportions, health diet diversity, emotional and restrained eating behavior changes. Furthermore, classification using gene–gene interactions between rs9939224 and rs5082 significantly predicted the best response, with a greater decrease in BMI (p = 0.038; − 11.45% for the best response group (CEPT GT/TT × APOA2 AA) vs. + 2.62% for the worst response group (CEPT GG × APOA2 AG/GG)). CETP and APOA2 SNPs can be used as candidate markers to predict the efficacy of digital healthcare lifestyle modifications based on genotype-based precision medicine.Trial registration: NCT03465306, ClinicalTrials.gov. Registered March, 2018.

Effects of a digital cognitive behavioral therapy for insomnia on sleep and alcohol consumption in heavy drinkers: A randomized pilot study.

Insomnia is a well-established, prospective risk factor for Alcohol Use Disorder. Thus, targeting sleep problems could serve as a novel and efficacious means of reducing problematic drinking. Here, we examined the potential utility of a well-validated, interactive, easy to use, self-paced digital cognitive behavioral therapy for insomnia program. In a randomized, single-blind pilot study, we examined the impact of treatment with Sleep Healthy Using the Internet (SHUTi) on drinking and sleep outcomes in a sample of heavy drinkers with insomnia. Heavy drinking men (n = 28) and women (n = 42) with insomnia were randomly assigned to complete either the SHUTi program or a control patient education program. Subjective measures of sleep and alcohol use were administered at baseline, immediately following completion of the intervention, 3 months post-intervention, and 6 months post-intervention. Sleep outcomes were assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index. Drinking outcomes were assessed using the 30-Day Timeline Follow-Back calendar. We used linear mixed effects models to compare groups on both insomnia and drinking outcomes. Data from all 70 subjects (SHUTI: n = 40; control: n = 30) were analyzed. Linear mixed effects models showed that SHUTi significantly reduced insomnia symptoms (p = 0.01) and drinking outcomes (ps < 0.05) more than the control condition over time. Trend-level effects on sleep quality (p = 0.06) were also observed. No adverse events were reported. Improving sleep may be an effective treatment intervention for reducing hazardous drinking in at-risk individuals. Further, findings provide preliminary support for the implementation of an easily accessible health behavior intervention with significant public health impact in a high-risk population.

A Randomized Clinical Trial Testing the Effect of Digital Behavioral Interventions on Pain and Mental Health Among Adults with Sickle Cell Disease

Background: Patients with sickle cell disease (SCD) suffer a significant disease burden that affects their psychosocial well-being. Digital cognitive-behavioral therapy (CBT) has been utilized in other patient populations and shown to have clinical benefits. Although evidence-based, non-pharmacological interventions for pain management are widely used in other populations, this is not well studied in SCD. There are currently no large-scale, adequately powered clinical trials that evaluate the effectiveness and dissemination potential of digital behavioral pain management interventions for adults with SCD. Objective: The primary goal was to compare the effectiveness of two mobile-phone-delivered programs: 1) digital CBT program tailored for adults with SCD (CBT); or 2) pain and SCD education (Education) for reducing pain symptoms. The secondary goal was to assess whether baseline depression symptoms moderated the effect of these interventions on pain outcomes. Methods: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA) is a multisite, randomized, pragmatic, comparative effectiveness trial conducted at seven comprehensive sickle cell centers and several community-based organizations in the U.S. The study enrolled adults with SCD who reported chronic pain or using short or long-acting opioids daily. Participants were randomized in a 1:1 ratio to receive either the CBT or Education programs. Both programs utilized identical Facebook Messenger chatbot apps, only the content differed. All intervention participants received health coach support involving weekly phone calls or text messages for a duration of 12 weeks. Participants completed follow up assessments at 3 and 6 months, and daily e-diary entries of 0-10 pain numerical rating scale, mood, and opioid use. The primary outcome was the 6-month change in the PROMIS pain interference. Secondary outcomes included average daily pain intensity for a 2-week period at each time point, change in mean % body area affected by pain (measured by a ‘paintable’ body image within the mobile app), PHQ-9 depression, GAD-7 anxiety, Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) quality of life (social functioning and emotional impact), and Sickle Cell Self-Efficacy Scale (SCSES). Generalized linear mixed models were used to compare changes in 6-month outcomes between study arms after accounting for design variables (study site and baseline depression). Results: Of the 574 participants screened for eligibility, 359 (63%) were consented and randomized (178 to CBT and 181 to Education). Seventy-five percent of participants connected with the chatbot but only 47% completed at least one CBT/education lesson. However, 80% of participants had at least one text message, phone or video session with a health coach. At 6-months, there was a significant decline in pain interference within each arm (CBT [-2.13, 95%CI (-3.42, -0.84)] and Education [-2.66, 95%CI (-3.97, -1.36)]); however, this decline did not differ between arms (p=0.57). There was not a significant 6-month change in daily pain intensity for either arm, however, for % body area covered in pain, both CBT and education conferred a similar relative decrease, 19.2% and 17.1%, respectively. There were significant 6-month improvements within-arms for PHQ-9, GAD-7, and both ASCQ-Me measures, but no between-arm differences emerged. (Table 1). Of these, only the 6-month change in ASCQ-Me emotional impact approached a significant difference between arms with digital CBT conferring slightly greater improvement in scores, 3.51 (95%CI: 2.29, 4.73) compared to education,1.79 (95%CI: .55, 3.04; p=.05). Baseline PHQ depression score (&amp;gt;= 10 vs &amp;lt; 10) did not moderate the effect of treatments on pain interference (p=0.52). Conclusions: Preliminary trial findings suggest that both digital CBT and Education, with health coach support, are effective approaches for management of SCD pain and mental health symptoms. Most participants connected with a health coach and may have derived benefit from this support, however, poor engagement with the digital CBT and education component of the study may have limited the study's ability to detect between arm differences. Secondary analyses will examine the effect of intervention engagement on treatment outcomes.

Assessing Pain Severity in Sickle Cell Disease Using Animations and a Graphical Body Image

Introduction: Adults living with sickle cell disease (SCD) most frequently seek medical care due to pain. To determine the most efficacious treatment plan for patients presenting with pain, providers must first accurately assess and diagnose the pain. Unfortunately, the current approaches for assessing pain are inadequate. Combined with medical provider biases, patients can often have their pain symptoms misinterpreted, ignored, or blatantly dismissed. To address this issue, we partnered with stakeholders, human-centered designers, and software engineers to design a novel pain assessment tool, called Painimation. Painimation allows patients to communicate their pain quality, intensity, and location using abstract animations and a paintable body image. Painimation has been validated in a general population with chronic pain, but there is limited data validating this approach in SCD. Preliminary data on the use of Painimation by adults with SCD (N = 67) found that those who described their pain using the “throbbing” animation had less severe pain symptoms than those endorsing the “shooting” animation. Objective: To replicate and extend prior findings by determining whether pain animations and body image data are associated with pain outcomes in a large cohort of adults with SCD. We hypothesized that the presence of shooting pain and greater body surface areas affected by pain would be associated with more severe pain outcomes and mental health symptoms. Methods: We performed a secondary analysis on baseline data from the “Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA)” Trial-a multisite randomized, controlled trial in adults with SCD and chronic pain. Eligible patients were randomized 1:1 to either digital cognitive behavioral therapy or digital education; in addition, both arms received at least 12 weeks of health coach support. At baseline, participants completed a battery of questionnaires and tracked their pain intensity (0-10) by the Visual Analog Scale (VAS) and mood daily via a mobile app. The Painimation app presents a front and back 2-dimensional body image that is paintable to indicate areas affected by pain. Users choose from abstract animations intended to represent different pain qualities; the intensity of the animations can be adjusted, and up to three can be selected. For the purpose of the analyses, participants were categorized into “Shooting Pain” vs “No Shooting Pain” and “Throbbing with Shooting and Stabbing” vs “Throbbing Alone,” based on our prior study. Participants were also split into groups based on whether the proportion of the body image painted was less than the median (&amp;lt;9.8% vs &amp;gt;=9.8%). Baseline characteristics and demographics were compared between groups, and multivariable regressions were used to estimate covariate-adjusted associations with the following outcomes at baseline: daily pain, Patient Reported Outcomes Measurement Information System (PROMIS) pain interference scale, Pain Catastrophizing Scale (PCS), Current Opioid Misuse Measure (COMM-9), and Adults Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) pain severity and frequency. Results: The trial enrolled 359 adults, mean age 36.3 (SD = 10.5), 66% female, 93% Black race. The “Shooting” painimation and greater body image scores were associated with all outcomes in univariate analyses (all p&amp;lt;0.01; Table 1) except for the proportion of “happy” mood days and anxiety scores. After controlling for age, depression, anxiety, % body image, and site, the shooting animations were independently associated with greater daily pain intensity (beta = 0.64; p = 0.046). After controlling for age, depression, and site, greater body image score was associated with daily pain intensity (beta = 1.18; p &amp;lt; 0.001), pain interference (beta = 2.87; p &amp;lt; 0.001), ASCQ-Me pain frequency (beta = 3.91; p =&amp;lt; 0.005), and ASCQ-Me pain severity (beta = 4.50; p = 0.002). Conclusion: Both the “shooting” animation and body image measures were associated with more severe pain outcomes. This study demonstrates that animations and body image data can be used to assess pain severity in SCD, more objectively than the 0-10 numeric VAS scale. Future studies should explore whether pain location and specific animation selected are associated with pain etiology, and determine whether this approach can differentiate different types of pain in SCD.

Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice.

Digital cognitive behavioural therapy for chronic insomnia (D-CBT-I) has been shown to be as efficacious as traditional CBT-I. However, not all patients achieve insomnia remission after treatment. We explored the factors influencing the effectiveness of D-CBT-I in a clinical practice. A total of 414 Asian chronic insomniacs were studied during a 6 week D-CBT-I intervention. All patients were assessed at baseline and posttreatment and were determined to be remitters or non-remitters, responders or non-responders by posttreatment criteria; Insomnia Severity Index (ISI <8) or ISI reduction ≥8, to examine whether remission and response status were associated with patient baseline characteristics. The average baseline ISI score in all subjects was 16.29 points. At posttreatment, 192 (46.4%) patients achieved ISI remission and 218 (52.7%) patients demonstrated an ISI response. An increased baseline early morning awakening time and ISI score were independently associated with a lower odds for remission (OR, 0.995 and 0.991, respectively). Increased baseline Patients Health Questionnaire-9 score was independently associated with higher odds for response (OR, 1.114). Our results suggest that D-CBT-I can be recommended as the first-line treatment for chronic insomnia, particularly in insomniacs with milder insomnia symptoms and more severe depressive symptoms. Meanwhile, the effectiveness of D-CBT-I was adversely affected by longer early morning awakening time and higher insomnia severity at pretreatment, which may be improved by more intense intervention and greater therapeutic support or by traditional CBT-I.

Real-world evidence for the use of digital cognitive behavioural therapy for insomnia within primary care

Zusammenfassung Hintergrund Durch die Einführung digitaler Gesundheitsanwendungen (DiGA) in Deutschland besteht seit Oktober 2020 ein digitales Therapieangebot für die chronische Insomnie durch die DiGA somnio (mementor DE GmbH, Leipzig, Deutschland). Diese setzt die leitliniengerechte kognitive Verhaltenstherapie für Insomnie (KVT-I) digital um und kann beim Vorliegen einer Insomniediagnose verordnet werden. Der Einsatz der DiGA macht es möglich, die digitale KVT‑I erstmalig im Rahmen einer Anwendungsbeobachtung in der Regelversorgung zu untersuchen. Ziel der Arbeit Durch die Untersuchung der Nutzerdaten von somnio soll ein umfassenderes Verständnis zur Wirkung der digitalen KVT‑I in der Regelversorgung ermittelt werden. Material und Methoden Wir haben die Daten von N = 5000 zufällig ausgewählten Nutzer:innen ausgewertet, welche somnio in den Jahren 2021–2022 abgeschlossen haben und bei Beginn einen Insomnieschweregrad gemäß Insomnie-Schweregrad-Index (ISI) ≥ 8 angaben. Die Insomnieschwere und das Schlafverhalten wurden über den Verlauf der digitalen Intervention deskriptiv ausgewertet. Innergruppenveränderungen wurden anhand von Cohen’s d berechnet, um Aufschluss über das jeweilige Effektmaß zu geben. Ergebnisse Die Auswertung zeigte eine Verringerung der mittleren ISI-Werte um −8,49 ± 5,39 Punkte zwischen Beginn und Abschluss der Anwendung (d = 1,58). Bei Abschluss erfüllten 57 % die Kriterien einer klinisch signifikanten Veränderung (Reduzierung ≥ 8 Punkte auf dem ISI) und 38 % erfüllten die Kriterien für eine Remission (ISI &lt; 8). Auswertungen der Tagebucheinträge zeigten eine deutliche Verbesserung der Schlafkontinuität und -qualität (ds = 0,68–1,07). Diskussion In Übereinstimmung mit kontrollierten Studien zeigen die Daten aus der Praxis, dass die Anwendung der digitalen KVT‑I zu klinisch bedeutsamen Verbesserungen der Insomnie und des Schlafs führen kann. Damit unterstützen die Ergebnisse den Einsatz digitaler Therapien in der Regelversorgung.

Implementing digital mental health interventions at scale: one-year evaluation of a national digital CBT service in Ireland

BackgroundIn recent years, exponential growth in digital innovations and internet access has provided opportunities to deliver health services at a much greater scale than previously possible. Evidence-based technology-enabled interventions can provide cost-effective, accessible, and resource-efficient solutions for addressing mental health issues. This study evaluated the first year of a supported digital cognitive behavioral therapy (CBT) service provided by the national health service in Ireland, which has been accessible to individuals who receive a referral from one of five referring groups: General Practitioners, Primary Care Psychology, Counselling Primary Care, Community Mental Health, and Jigsaw (a nationwide youth mental health service).MethodsA retrospective, observational study examining data from the service between April 2021 to April 2022 was conducted. Descriptive statistics on referrals, account activations, user demographics, program usage, and user satisfaction were extracted, and pre-to-post clinical outcomes for depression measured by the Patient Health Questionnaire-9 and for anxiety measured by the Generalised Anxiety Disorder-7 were analysed using linear mixed effect models.ResultsThere were 5,298 referrals and 3,236 (61%) account activations within the year. Most users were female (72.9%) and aged between 18 and 44 years (75.4%). The CBT programs were associated with significant reductions in both depression (β = 3.34, 95% CI [3.03, 3.65], p < 0.001) and anxiety (β = 3.64, 95% CI [3.36, 3.93], p < 0.001), with large effect sizes (Cohen’s d > 0.8). Time spent using the programs was also found to be a predictor of the variability in these clinical outcomes (p < 0.001), and accounting for this resulted in significantly better model fits (p < 0.001). User satisfaction ratings were also very high, exceeding 94%.ConclusionsEfforts to improve the representation of male and older adult users are warranted. However, overall, the results demonstrate how digital CBT can be provided at scale and lead to symptom reductions with large effect sizes for patients seeking help for depression and anxiety. The findings substantiate the continued use and expansion of this service in Ireland and the more widespread implementation of similar services in other international public healthcare settings.