Clinical trial NCT04091139: Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depressive Disorder
Anxiety Disorders
Keywords: Unified Protocol
Cognitive Behavioural Therapy
Depression
Anxiety
Adolescents
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Castle Peak Hospital
First posted: 2019-09-16
Enrollment: 27
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is to examine the effect of transdiagnostic cognitive behavioural therapy (Unified Protocol for adolescents, UP-A), in comparison with treatment-as-usual, in the reduction of depressive and anxiety symptoms among adolescents with common mental disorders.

All participants 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 UP-A condition would attend individual psychological 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 based on UP-A.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of depressive symptoms from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of anxiety symptoms from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
Secondary outcomes:
measure: Change of psychiatric diagnosis of common mental disorders (based on fifth edition of Diagnostic and Statistical Manual) from baseline to treatment completion
timeFrame: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment)
measure: Change of level of suicidality from baseline to treatment completion
timeFrame: UP-A: Week 0 (pre-treatment) and Week 12 (post-treatment); TAU: Week 0 (baseline), Week 12 (pre-treatment) and Week 24 (post-treatment)
measure: Change of functional impairment from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of self-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of parental-reported competencies and psychopathologies from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of depressive symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of anxiety symptoms throughout the treatment, from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of self-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
measure: Change of parental-reported problem severity throughout the treatment, from baseline to treatment completion and at the three-month follow-up
timeFrame: 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)
Other outcomes:
measure: Self-reported subjective satisfaction towards treatment
timeFrame: UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment)
measure: Parental-reported subjective satisfaction towards treatment
timeFrame: UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment)
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychology, The Chinese University of Hong Kong
state: HK
Study officials:
affiliation: Chinese University of Hong Kong
name: Sophie Yan Yan Cheung, MSocSc
role: PRINCIPAL_INVESTIGATOR
References: