A Randomized Controlled Trial with a Nine-month Follow-up of a locally adapted variant of group Unified Protocol (UP) for Chinese adults

Phase 4

• Conditions: F32; F33; F34; F40; F41; F43; Depressive episode; Recurrent depressive disorder; Persistent mood [affective] disorders; Phobic anxiety disorders

• Registration Number: DRKS00013470
• Lead Sponsor: Mind HK

Brief Summary

There has been increasing interest in transdiagnostic cognitive-behavioral therapy (CBT), which is more cost efficient yet yields similar effect sizes when compared to disorder-specific CBT. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders was adapted for Hong Kong Chinese adults with common mental disorders, such as depression and anxiety. It was piloted in community settings and delivered in a group format. Thirty-one Chinese adults (female = 93.5%, mean age = 44 years) with heterogeneous anxiety and depressive disorders were recruited from a number of public-funded community mental health centers in Hong Kong to participate in a pilot trial of a locally adapted variant of UP. Treatment consisted of 14 group sessions plus one individual session. Each group included six to nine participants. The diagnostic and outcome measures included Anxiety Disorders Interview Schedule for DSM-IV, The Chinese versions of Beck Depression Inventory-Revised (C-BDI-II), Beck Anxiety Inventory (C-BAI), Positive Affect subscale of Positive and Negative Affect Scale, and Work and Social Adjustment Scale. Results indicate significant improvement across a number of outcome measures, with moderate-to-large effect sizes for measures of depression (d = 1.11), anxiety (d = 0.67), positive affect (d = 0.54), and work and social functioning (d = 0.49). Furthermore, 45.2% and 29.0% of the participants scored within the normal range of C-BDI-II and C-BAI at posttreatment, respectively, compared to 3.2% and 6.5% at pretreatment. This pilot, uncontrolled trial demonstrated potential effectiveness of a locally adapted variant of group UP for Chinese adults with common mental disorders. It achieved comparable effect sizes to those observed in western populations.

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-06
• Study Start: 2018-07-26
• Results First Posted: 2020-11-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

(1) 18-65 years of age;
(2) capable of giving informed consent;
(3) having, at baseline assessment, a current DSM-IV TR principal diagnosis of mood-related disorders, e.g., unipolar mood disorders, anxiety disorders, adjustment disorders, hypochondriasis or bipolar disorder with recent depressive episode;
(4) being able to understand Cantonese and write Chinese to complete homework assignments;
(5) willing to be randomly assigned to either the Chinese adapted variant of UP or TAU groups; and
(6) if participants are on medication, the drugs prescribed and their dosage is optimal if it is in a stable state; any changes should be immediately reported to the research team.

Exclusion Criteria

(1) having a current diagnosis of substance abuse or dependence, or
a current or manic or hypomanic episode, schizophrenia or other psychotic disorders, or mental retardation;
(2) presenting psychiatric and medical conditions that are potentially lifethreatening (e.g., strong suicidal tendency), or terminal medical illnesses or those medical conditions severely limiting participation, comprehension or adherence to the treatment (e.g. dementia, pregnancy);
(3) receiving structured CBT-based psychological therapy or counselling; and (4) those with active psychotic symptoms in the past two years.

Study & Design

• Study Type: interventional
• Study Design: Not specified