Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms（CADS-D )

Official title

Digital Cognitive Behavioral Therapy for Chinese Adolescents With Depressive Symptoms（CADS-D ): A Randomized Clinical Trial

Overview

CADS-D aimes to evaluate the effectiveness and feasibility of a newly DCBT program for Chinese adolescents with depressive symptoms.

Detailed description

CADS-D is a single-center, two-arm, open-label randomized controlled trial. The trial targeted 12-18 years adolescents with depressive symptoms. Intervention group receives the digital cognitive behavioral therapy (DCBT) program for 6 weeks, while the control group receives the regular mental health curriculum provided by school staff for 6 weeks. Assessments are conducted at three time points: baseline, post-intervention (6 weeks), and at 3 months follow-up (18 weeks). The primary outcome is the effectiveness of DCBT. Secondary outcomes include the feasibility of DCBT, self-reported depressive severity, anxiety severity, psychological resilience, and the quality of life enjoyment and satisfaction.

Interventions

• Other Digital cognitive behavioral therapy(DCBT)
  Moca is a mobile application designed to deliver structural CBT for adolescents with mood problems. Moca provides six-twelve guided sessions with an estimated proceeding duration of 25-45min each, developed to be processed weekly. The content of each session includes the introduction of the core concepts and principles of CBT, psychological counseling dialogue, skill exercises, and homework. Content presentation forms include text, animation, audio, comics, etc. At the end of each module, the pa
• Other Regular mental health curriculum
  The content of regular mental health curriculum includes mental health education lecture. Few lectures address the knowledge and skills involved in CBT in such education lecture.

Primary outcome measures

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline [Time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)]

Secondary outcome measures (5)

• Feasibility of DCBT [Time frame: 6 weeks]
• Changes in PHQ (9-item Patient Health Questionnaire) scores from baseline [Time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)]
• Changes in GAD-7 (Generalized Anxiety Disorder 7-item Scale) scores from baseline [Time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)]
• Changes in CD-RISC ( Connor-Davidson Resilience Scale) scores from baseline [Time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)]
• Changes in PQ-LES-Q (The Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire) scores from baseline [Time frame: Baseline of intervention period, 6 weeks, and 3 months follow-up (18 weeks)]

Eligibility criteria

Inclusion criteria

• Age 12 to 18 years;
• Scored 28 or higher on the children's depression rating scale-revised (CDRS-R);
• Have the ability to read and write in Chinese;
• Participant and at least one of their guardians provided written consent;
• Have access to mobile phone and internet.

Exclusion criteria

• The researchers assessed that the adolescent's depressive symptoms were too severe to participate to CADS-D;
• Scored 5 or higher on item 13 (suicidal ideation) on CDRS-R;
• Participants who met diagnosis of other mental disorder except depression;
• Severe physical illnesses or other physical disabilities that prevented the use of DCBT;
• Within the past three months or currently undergoing any antidepressant treatment, including medication therapy, psychotherapy, and physical therapy;
• Unavailability to follow up months after intervention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Chongqing Medical University — Chongqing

Publications

• Barker MM, Beresford B, Bland M, Fraser LK. Prevalence and Incidence of Anxiety and Depression Among Children, Adolescents, and Young Adults With Life-Limiting Conditions: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Sep 1;173(9):835-844. doi: 10.1001/jamapediatrics.2019.1712. PMID 31282938
• Janssens KA, Rosmalen JG, Ormel J, van Oort FV, Oldehinkel AJ. Anxiety and depression are risk factors rather than consequences of functional somatic symptoms in a general population of adolescents: the TRAILS study. J Child Psychol Psychiatry. 2010 Mar;51(3):304-12. doi: 10.1111/j.1469-7610.2009.02174.x. Epub 2009 Sep 28. PMID 19788552
• Pettit JW, Lewinsohn PM, Roberts RE, Seeley JR, Monteith L. The long-term course of depression: development of an empirical index and identification of early adult outcomes. Psychol Med. 2009 Mar;39(3):403-12. doi: 10.1017/S0033291708003851. Epub 2008 Jul 8. PMID 18606049
• Weissman MM, Wolk S, Goldstein RB, Moreau D, Adams P, Greenwald S, Klier CM, Ryan ND, Dahl RE, Wickramaratne P. Depressed adolescents grown up. JAMA. 1999 May 12;281(18):1707-13. doi: 10.1001/jama.281.18.1707. PMID 10328070
• O'Keeffe S, Martin P, Goodyer IM, Kelvin R, Dubicka B; IMPACT Consortium; Midgley N. Prognostic Implications for Adolescents With Depression Who Drop Out of Psychological Treatment During a Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2019 Oct;58(10):983-992. doi: 10.1016/j.jaac.2018.11.019. Epub 2019 Apr 1. PMID 30946974
• Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2. PMID 22305766
• Davey CG, Chanen AM, Hetrick SE, Cotton SM, Ratheesh A, Amminger GP, Koutsogiannis J, Phelan M, Mullen E, Harrison BJ, Rice S, Parker AG, Dean OM, Weller A, Kerr M, Quinn AL, Catania L, Kazantzis N, McGorry PD, Berk M. The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial. Lancet Psychia PMID 31371212
• Zhou X, Teng T, Zhang Y, Del Giovane C, Furukawa TA, Weisz JR, Li X, Cuijpers P, Coghill D, Xiang Y, Hetrick SE, Leucht S, Qin M, Barth J, Ravindran AV, Yang L, Curry J, Fan L, Silva SG, Cipriani A, Xie P. Comparative efficacy and acceptability of antidepressants, psychotherapies, and their combination for acute treatment of children and adolescents with depressive disorder: a systematic review an PMID 32563306

Identifiers

NCT: NCT07163013 · 1stChongqingMu2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗