Aug 2026· JMIR Research Protocols· Vol 15, pp. e99700-e99700· 0 citations· 34 references
Medicine
TL;DR
If effective, the 3D Program may serve as a scalable, cost-efficient adjunct to routine care for women with depressive symptoms in public health systems, while biomarker findings may lay the groundwork for future trials examining predictors of response.
Abstract
Abstract Background Depressive disorders are a leading cause of disability among women worldwide, yet existing interventions often fail to account for the biological and sociocultural factors shaping women’s risk and symptom presentation. Objective In response, this randomized, single-blind, controlled trial will evaluate the efficacy of the 3D Program—a gender-sensitive, guided internet-based cognitive behavioral therapy (iCBT) intervention for women with moderate depressive symptoms. Methods A total of 120 women presenting with moderate depressive symptoms (17-item Hamilton Depression Rating Scale score 17‐23), aged 18 to 45 years, will be randomized to receive either the 10-week 3D Program or informational video content, with both groups continuing treatment as usual. The 3D Program will integrate personalized therapist support, self-guided digital modules, and a moderated online group, with content cocreated alongside women with lived experience of depressive symptoms. The primary outcome will be the change in depressive symptom severity, measured by the 17-item Hamilton Depression Rating Scale at 12- and 26-week postbaseline assessments. Secondary outcomes will include functioning, quality of life, perceived stress, and menstrual-related distress. Additionally, the study will explore potential biological predictors of treatment response, analyzing metabolic markers related to tryptophan metabolism and adrenal steroid pathways across multiple biological matrices. Data analyses will use linear mixed-effects models and multivariate techniques to examine treatment effects and possible biomarker associations. Results The trial was funded in October 2023 (grant PI23/00257, Spanish Ministry of Economy and Competitiveness), and ethical approval was obtained in February 2024. The trial was registered in July 2025 (ClinicalTrials.gov NCT07060690). Data collection began in March 2026 and is projected to conclude in August 2027. As of April 2026, a total of 8 participants have been enrolled. Data analysis has not yet commenced. The results are expected to be published in the summer of 2028. Conclusions This trial aims to address critical gaps in accessible, personalized, and gender-sensitive mental health care. If effective, the 3D Program may serve as a scalable, cost-efficient adjunct to routine care for women with depressive symptoms in public health systems, while biomarker findings may lay the groundwork for future trials examining predictors of response.
Background Adolescents with depressive symptoms are at increased risk of social functional impairment and are more likely to develop major depressive disorder. Digital interventions offer advantages, such as high accessibility, especially for adolescents. However, evidence on the effectiveness of web-based psychological interventions in alleviating depressive symptoms among adolescents remains limited. Objective This study aims to develop a brief web-based psychological intervention tailored to the developmental and psychological characteristics of Chinese adolescents and to evaluate its effectiveness and influencing factors. Methods In a 2-arm randomized controlled trial, adolescents aged 12 to 18 years with depressive symptoms were recruited from high schools in China. Eligible participants were randomly assigned in a 1:1 ratio to the intervention group (n=212) or the control group (n=224). Participants in the intervention group received a 4-week brief web-based emotional cognitive training program, whereas those in the control group received a web-based psychoeducation program. Nonprofessional helpers provided minimal support through text messages or phone calls. The primary outcome was depressive symptom severity. Secondary outcomes included the depressive symptom remission rate, changes in anxiety symptoms, suicidal ideation, and resilience. Data were collected at baseline (T0), postintervention (T1), and at 1- and 3-month follow-ups (T2 and T3). Statistical analyses included analysis of covariance (ANCOVA), logistic regression analysis, and mediation analysis. Results Two-way repeated-measures ANCOVA revealed a significant time effect (F3,1461=82.515; P<.001; η2p=0.140) on depressive symptom severity, with significantly lower scores at T1, T2, and T3 than at T0. No significant group effect (F1,1461=1.039; P=.31; η2p=0.001) or time-by-group interaction (F3,1461=2.424; P=.06; η2p=0.005) for depressive symptom severity was observed. Post hoc exploratory analysis showed that among adolescents with anxiety symptoms, the intervention group exhibited a higher depressive symptom remission rate at T1 than the control group (adjusted odds ratio 1.39, 95% CI 1.05-1.85; P=.02; number needed to treat=7). Additionally, the intervention group showed significantly greater improvements in the interpersonal support dimension of resilience at T1 (least squares mean difference=1.79, 95% CI 0.53-3.06; Cohen d=0.37, 95% CI 0.11-0.63; P=.006; false discovery rate–adjusted P=.04). Exploratory mediation analysis identified a significant indirect effect between the intervention and depressive symptom remission via the interpersonal support dimension of resilience at T1 (indirect effect=0.08, 95% CI 0.02-0.14; P=.009). Conclusions The brief web-based psychological intervention showed no significant difference from web-based psychoeducation in reducing depressive symptoms across the 3-month follow-up period. Post hoc exploratory analyses detected a potential between-group difference in depressive symptom remission among adolescents with comorbid anxiety symptoms, with interpersonal support showing a significant mediating association. These exploratory findings may provide new insights into identifying the target population suitable for brief web-based psychological interventions and inform the development of tailored interventions in the future. Trial Registration Chinese Clinical Trial Registry ChiCTR2400090235; https://www.chictr.org.cn/showproj.html?proj=243991
Pei Liu, Xin-Wei Wang, Xiaoxia Duan et al.· JMIR mHealth and uHealth· 0 citations
Abstract Background Adolescent depression is a major public health concern with limited access to effective treatments. Behavioural activation (BA) is a suitable intervention for digital delivery, but definitive adolescent trials are scarce. Objective To evaluate whether therapist-guided and self-guided internet-based BA (I-BA) are more efficacious and cost-effective than treatment as usual (TAU) for adolescents with mild to moderate major depressive disorder (MDD). Methods Single-blinded, parallel-group randomised controlled trial with economic evaluation. A total of 219 adolescents (13–17 years) with mild-moderate MDD were randomised (1:1:1) to 10 weeks of therapist-guided I-BA, self-guided I-BA or TAU. Both I-BA interventions included adolescent and parent modules. Primary outcome: change in depression severity (Children’s Depression Rating Scale-Revised, CDRS-R, range 17–113) from baseline to 3-month follow-up (primary endpoint), assessed by blinded evaluators. Analyses included all randomised participants, with statisticians blinded to allocation. A health economic evaluation was performed at the primary endpoint. Findings Baseline CDRS-R indicated clinically significant depression (mean 57.1, threshold ≥40). Retention at the primary endpoint was 82.6%. Mean reductions were 17.0 (therapist-guided I-BA), 16.0 (self-guided I-BA) and 11.6 (TAU), bringing both I-BA groups below the clinical cut-off. Therapist-guided I-BA showed greater reductions than TAU (estimated mean difference −4.68; 95% CI −0.05 to −9.30; p=0.048, d=−0.47; 95% CI 0.00 to −0.93), while self-guided I-BA was not statistically superior (estimated mean difference −3.44; 95% CI −8.05 to 1.17, p=0.14, d=−0.37; 95% CI −0.86 to 0.12). The predefined six-point clinical important difference was not met. Results were sensitive to modelling: significance disappeared with random slopes but effect estimates were similar; baseline-adjusted analyses favoured both I-BA arms. Both I-BA options had lower costs than TAU (p=0.03, p<0.001), with self-guided I-BA being the most economical. Conclusions Therapist-guided I-BA reduced depressive symptoms at lower cost than TAU, but clinical importance and robustness are uncertain. Self-guided I-BA showed no clear superiority but was cost-efficient. Clinical implications Therapist-guided I-BA may increase access to evidence-based care for adolescents with MDD, though findings require cautious interpretation. Self-guided I-BA may be useful where therapist access is limited, but more research is needed.
Rebecca Andersson, J. Åhlén, F. Lenhard et al.· BMJ mental health· 0 citations
Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives. This is a 3-site superiority randomized controlled trial including 154 young people (12–17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan. Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint. ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412.
L. Fernández de la Cruz, Anita Birovecz, Per Andrén et al.· Trials· 0 citations
Abstract Background Up to 1 in 10 fathers experience postnatal depression. Fathers are less likely to seek help and receive adequate treatment than depressed mothers. Digital treatments hold significant potential for engaging and supporting fathers, but no effective program exists. Objective The aim of the study is to evaluate the efficacy of an online cognitive behavioral therapy program, DadBooster, for treating postnatal depression in fathers. Methods A parallel, 2-group randomized controlled trial (N=50) was conducted to test the superiority of DadBooster over waitlist control who received routine care. Randomization was computer-generated, with allocation concealment maintained through central, computer-automated administration. Participating fathers were aged 18 years or older, had a baby younger than 12 months, had a depression diagnosis using the Quick Structured Clinical Interview for DSM-5 (QuickSCID-5), were not receiving depression treatment, and did not meet criteria for other mental health disorders. They were recruited Australia-wide and completed questionnaires online and assessments by telephone. Primary outcomes were depression symptom severity (Depression Anxiety Stress Scales-21 [DASS-21]) and depressive episode remission (QuickSCID-5) 12 weeks after enrollment. Participants were not blinded. Assessments (QuickSCID-5) and data analysis were conducted blind to allocation. Results Participants (N=50) were randomized (DadBooster: n=25; waitlist control: n=25) and analyzed as assigned; the trial is complete. Mean depression symptoms (DASS-21) at 12 weeks were significantly lower for DadBooster than waitlist control (adjusted mean difference −7.26, 95% CI −11.34 to −3.18; F1,47=12.81; P<.001; ηp2=0.21); average scores reduced by 72% (compared to 40% in waitlist control) and dropped to the “normal” range at 12 weeks. Of the DadBooster participants assessed, 2 of 23 (9%) still met diagnostic criteria (QuickSCID-5) at 12 weeks compared with 7 of 24 (29%) waitlist controls; not significant (Fisher exact test: P=.14). Significant differences were found for stress (adjusted mean difference −6.55, 95% CI −11.01 to −2.09; F1,47=8.73; P=.005; ηp2=0.16), parenting self-efficacy (adjusted mean difference 4.06, 95% CI 1.16-6.95; F1,47=7.93; P=.007; ηp2=0.14), and negative automatic thoughts (adjusted mean difference −18.10, 95% CI −29.79 to −6.42; F1,47=9.71; P=.003; ηp2=0.17). Participants engaged well with the intervention—80% (20/25) visited 4 or more sessions—and attrition was low. No adverse events were identified. Conclusions This randomized controlled trial demonstrates the efficacy of DadBooster, the first online treatment targeting clinically diagnosed postnatal depression in fathers, addressing a critical gap in the treatment of postnatal depression, an area that has until recently been primarily focused on mothers. By providing evidence for an intervention specifically designed for fathers with potential for broader scalability, this study advances the limited literature on treatment approaches for postnatal depression in fathers. Given its accessibility, privacy, and convenience, DadBooster is a promising and potentially impactful intervention for supporting fathers.
Charlene Holt, J. Ericksen, A. W. Gemmill et al.· Journal of Medical Internet...· 0 citations
Sleep disturbances are reported in up to 80% of persons with inflammatory arthritis (IA) and are poorly addressed. Cognitive-behavioral therapy for insomnia (CBTi) is the first-line insomnia treatment in the general population, but access is limited. Internet-delivered CBT for insomnia (ICBTi) overcomes accessibility barriers. A randomized waitlist-controlled pilot trial was conducted to determine the acceptability and preliminary efficacy of ICBTi for individuals with inflammatory arthritis and insomnia symptoms.
Participants with IA and symptoms of insomnia were recruited through social media and patient-partner organizations and randomly assigned to the ICBTi treatment group (n= 24; 6 modules over 8 weeks) or the waitlist-control group (n= 26). Participants completed surveys at baseline, 8 weeks (post-treatment), and 3 months later. Treatment group participants completed questions about treatment perceptions. The Insomnia Severity Index (ISI) (maximum score of 28) assessed insomnia symptoms at each time point. Paired sample t-tests were used to analyze changes in ISI scores over time for each group.
The sample included 50 participants with IA and insomnia symptoms (Table 1). Post treatment completion, most participants in the treatment group rated the ICBTi modules as moderately or extremely useful (84%) and were moderately or extremely satisfied (89%) with the program. Seventy-three percent of treatment group participants self-reported moderate or extreme improvements in sleep. However, only 52% of the treatment group completed the entire program. Feedback included wanting more relevance to arthritis and chronic pain, and a guide alongside the intervention. The mean baseline ISI score was 16.7 in the treatment group and 14.9 in the control group. Twenty treatment groups and 24 control group participants completed the 8-week survey. The mean (95% CI) change in ISI scores pre- to post-treatment in the treatment group was −4.95 (−6.77, −3.13), p<.001, and −0.94 (−.38, 2.26) in the control group, a non-significant difference. Eighteen treatment group and 21 control group participants completed the 3-month survey. The mean (95% CI) change in ISI scores from pre-treatment to the 3-month follow-up was −5.28 (−7.62, −2.93, p<.001) in the treatment group and −0.83 (−1.53, 3.20) in the control group, a non-significant difference.
Table 1
Characteristics of the Sample
The Internet-delivered CBTi program was acceptable and perceived as useful by most participants but could benefit from further adaptation to arthritis-specific needs. The results suggest efficacy of ICBTi among individuals with arthritis. A larger randomized-controlled trial with a larger, more diverse sample is needed to determine the effectiveness of using ICBTi to help people manage the double-burden of insomnia and arthritis.
Supported by a CIORA grant
Emilie McGuire, Nicole J. Andersen, Josée Savard et al.· Journal of Rheumatology· 0 citations
The present study aimed to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Schema Therapy (ST) on reducing catastrophizing in young adults with depressive symptoms. This applied study employed a quasi-experimental pretest–posttest design with a control group and a two-month follow-up period. The statistical population consisted of young adults diagnosed with depressive disorder who referred to counseling and psychological clinics in District 1 of Tehran between December 2024 and June 2025. From 224 eligible individuals, 45 participants meeting the inclusion criteria were selected using purposive sampling and randomly assigned to three groups: CBT (n = 15), ST (n = 15), and control (n = 15). Both intervention groups participated in eight structured group therapy sessions based on standardized treatment protocols, while the control group received no psychological intervention during the study period. Data were collected using validated self-report measures assessing depressive symptoms and catastrophizing. Statistical analysis was conducted using repeated measures analysis of variance (ANOVA) and Bonferroni post hoc tests in SPSS version 26, after verifying statistical assumptions. The results of repeated measures ANOVA indicated a significant main effect of time (p < 0.001) and a significant time × group interaction effect (p < 0.001) on catastrophizing, while the main effect of group was not statistically significant (p > 0.05). Bonferroni post hoc comparisons showed that both CBT and ST groups had significantly lower posttest catastrophizing scores compared to the control group (p < 0.001). However, no statistically significant difference was observed between the CBT and ST groups at posttest (p > 0.05). Pairwise comparisons across time demonstrated significant reductions in catastrophizing from pretest to posttest and from pretest to follow-up in both intervention groups (p < 0.001), with maintenance of treatment effects at follow-up. Both Cognitive Behavioral Therapy and Schema Therapy were effective in significantly reducing catastrophizing in young adults with depressive symptoms, and their effects were sustained over time; however, no significant difference was found between the two interventions in terms of overall effectiveness.
Shily Rahemi Nooran, T. Tizdast, Bita Nasrolahi· Mental Health and Lifestyle...· 0 citations
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