A Randomized-controlled Trial of a Locally Adapted Unified Protocol - Transdiagnostic Cognitive Behavioural Therapy for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Depressive Disorder
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change of depressive symptoms from baseline to treatment completion and at the three-month follow-up
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. Ehrenreich and colleagues developed UP for adolescents (UP-A). The current study aims at evaluating efficacy of UP-A for the treatment of emotional disorders in Chinese adolescents in Hong Kong.
The current study would recruit 27 Chinese-speaking patients, age 13 to 18, with a primary diagnosis of any Diagnostic and Statistical Manual (Fifth edition) anxiety disorders and/or depressive disorder. They would be randomized into one of the two treatment arms, namely UP-A treatment condition (UP-A), and treatment-as-usual (TAU) condition. Following randomization, participants in the UP-A condition would attend individual treatment based on UP-A, which last for 10 to 12 weeks. Participants in the TAU condition would be provided with usual clinical psychological service (i.e. treatment as usual) in the first 12 weeks before they start attending the same individual treatment program.
Primary outcomes would be patient's self-rated measures on clinical symptoms, and secondary outcomes would be their clinical diagnoses, parent-rated and other self-rated measures. It is hypothesized that, comparing to those in TAU, participants in the UP-A condition would show improvements in depressive symptoms, anxiety symptoms and functional impairment at the end of treatment. When the outcomes of all participants are combined, it is hypothesized that participants will show demonstrate improvement in depressive symptoms, anxiety symptoms, and functional impairment after completing the UP-A and at the 3-month follow-up.
Detailed Description
A Chinese treatment protocol would be developed based on the UP-A. The adolescent program consists of 8 modules, and the parent program consists of 3 modules. Similar to the work by Ehrenreich and Barlow, a flexible modular approach would be adopted, when extra sessions would be arranged to cater for individual treatment needs and heterogeneity of symptom severity. The whole treatment comprised of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardian. The total duration would be around 3 months. Each treatment sessions would be around 1 hour.
Investigators
Sophie Yan Yan Cheung
Clinical Psychologist
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Age between 13 to 18 years.
- •Primary diagnosis of any depression and/or anxiety disorders in fifth edition of the Diagnostic and Statistical Manual
- •Use Chinese as primary written language
- •For adolescents on medication, there must be 6-week stabilization period before study entry
Exclusion Criteria
- •Diagnoses of psychotic disorders, organic brain disease, bipolar disorder
- •In high risk of self-harm or suicide
- •Significant cognitive impairment (intellectual quotient lower than 80)
- •Autism Spectrum Disorders
- •Externalizing disorders with serious treatment interfering disruptive behavioural problems or substance abuse
- •Attending concurrent psychotherapy
- •Experience of attending a full-course of cognitive behavior therapy for anxiety or depression
Outcomes
Primary Outcomes
Change of depressive symptoms from baseline to treatment completion and at the three-month follow-up
Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up)
Beck Depression Inventory for Youth (BDI-Y) * One of the inventories in the Beck Youth Inventories of Emotional and Social Impairment (Second Edition, Chinese version). * Construct measured: depressive symptoms. * Total scores would be converted into T-scores (range from 20-81) and descriptive classifications (normal, mild, moderate and severe) according to aged-norm. * The higher the T-scores, the more severe the depressive symptoms.
Change of anxiety symptoms from baseline to treatment completion and at the three-month follow-up
Time Frame: UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up)
Beck Anxiety Inventory for Youth (BAI-Y) * One of the inventories in the Beck Youth Inventories of Emotional and Social Impairment (Second Edition, Chinese version). * Construct measured: anxiety symptoms. * Total scores would be converted into T-scores (range from 20-81) and descriptive classifications (normal, mild, moderate and severe) according to aged-norm. * The higher the T-scores, the more severe the anxiety symptoms.
Secondary Outcomes
- Change of self-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up))
- Change of functional impairment from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up))
- Change of parental-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 12 (post-treatment) and Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 24 (post-treatment) and Week 36 (follow-up))
- Change of level of suicidality from baseline to treatment completion(UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment))
- Change of parental-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 1-12 (4-6 parent sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (4-6 parent sessions), Week 24 (post-treatment), Week 36 (follow-up))
- Change of psychiatric diagnosis of common mental disorders (based on fifth edition of Diagnostic and Statistical Manual) from baseline to treatment completion(UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment))
- Change of anxiety symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up))
- Change of self-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up))
- Change of depressive symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up(UP-A: Week 0 (pre-treatment), Week 1-12 (10-12 treatment sessions), Week 12 (post-treatment), Week 24 (follow-up); TAU: Week 0 (baseline), Week 12 (pre-treatment), Week 13-24 (10-12 treatment sessions), Week 24 (post-treatment), Week 36 (follow-up))