Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong

NCT04091139 | Completed Phase 2

• 1 other identifier: UPAHK01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

Unified Protocol; Cognitive Behavioural Therapy; Depression; Anxiety; Adolescents

Outcome Measures

Primary Outcomes (2)

• Change of depressive symptoms from baseline to treatment completion and at the three-month 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.

  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 anxiety symptoms from baseline to treatment completion and at the three-month 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.

  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 (9)

• 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 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 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 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 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)

Other Outcomes (2)

• Self-reported subjective satisfaction towards treatment

  UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment)

• Parental-reported subjective satisfaction towards treatment

  UP-A: Week 12 (post-treatment); TAU: Week 24 (post-treatment)

Study Arms (2)

Unified protocol for adolescents (UP-A)

EXPERIMENTAL

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. The goal of the UP is to help patients to cultivate a greater willingness to experience uncomfortable emotions and to reduce maladaptive emotion response tendencies, so as to lessen the intensity and frequency of uncomfortable emotions. Ehrenreich and colleagues modified from the original UP and developed the UP for adolescents (UP-A). A Chinese treatment protocol would be developed based on the UP-A. Contents of the treatment includes motivational enhancement, psychoeducation of emotion, avoidance and emotion driven behaviours, interoceptive exposure, cognitive reappraisal, emotion awareness training and emotion exposure. It consists of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardians.

Behavioral: Unified protocol for adolescents (UP-A)

Treatment as usual (TAU)

ACTIVE COMPARATOR

TAU participants will receive usual clinical psychological service provided in the clinic (i.e. treatment as usual) in the first 12 weeks, before they start receiving same individual treatment program based on UP-A.

Behavioral: Treatment as usual (TAU)

Interventions

Unified protocol for adolescents (UP-A) BEHAVIORAL

The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. The goal of the UP is to help patients to cultivate a greater willingness to experience uncomfortable emotions and to reduce maladaptive emotion response tendencies, so as to lessen the intensity and frequency of uncomfortable emotions. Ehrenreich and colleagues modified from the original UP and developed the UP for adolescents (UP-A). A Chinese treatment protocol would be developed based on the UP-A. Contents of the treatment includes motivational enhancement, psychoeducation of emotion, avoidance and emotion driven behaviours, interoceptive exposure, cognitive reappraisal, emotion awareness training and emotion exposure. It consists of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardians.

Unified protocol for adolescents (UP-A)

Treatment as usual (TAU) BEHAVIORAL

TAU participants will receive usual clinical psychological service provided in the clinic (i.e. treatment as usual) in the first 12 weeks, before they start receiving same individual treatment program based on UP-A.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Castle Peak Hospital: collaborator

Study Sites (1)

Department of Psychology, The Chinese University of Hong Kong

Hong Kong, HK, HK, Hong Kong

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sophie Yan Yan Cheung, MSocSc

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: September 24, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)