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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anxiety Disorders; Depressive Disorder

Treatments: Behavioral: Unified protocol for adolescents (UP-A); Behavioral: Treatment as usual (TAU)

Study type: Interventional

Funder types: Other

Identifiers

NCT04091139

UPAHK01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Unified protocol for adolescents (UP-A)

Experimental group

Description:

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.

Treatment:

Behavioral: Unified protocol for adolescents (UP-A)

Treatment as usual (TAU)

Active Comparator group

Description:

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:

Behavioral: Treatment as usual (TAU)