Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013470
Enrollment
103
Registered
2018-07-26
Start date
2014-03-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 F33 F34 F40 F41 F43

Interventions

Group 1: Chinese adapted variant of Unified Protocol (UP) Group 2: Treatment-as-usual (TAU)

Sponsors

Mind HK
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. Anxiety Disorders Interview Schedule for DSM-IV (Lifetime version) (ADIS-IV; DiNardo et al., 1994) were used to assess the presence of diagnosis and severity of clinical symptoms and emotions. ADIS-IV is a semi-structured diagnostic clinical interview focusing on DSM-IV diagnoses including panic disorder, agoraphobia, social phobia, generalized anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, specific phobia, major depressive disorder, dysthymia, somatoform disorder as well as substance and alcohol use. Clinical Severity Rating (CSR) is rated on a scale from 0 (no symptoms) to 8 (extremely severe symptoms) with a score of 4 or above as passing the clinical level, implying fulfilling the diagnostic criteria for a DSM-IV disorder. Full ADIS-IV-L was administered at the intake which assessed both current and past episode of disorder, while a shortened version with the assessment on the only current episode was administered in the post and 9-month-follow-up. The author was involved in the intake assessment, while all post-treatment assessments were conducted by independent evaluators who are blind to treatment condition allocation. Both clinical psychologists and clinical psychology trainees were invited to volunteer as ADIS interviewers. All ADIS interviewers were trained and examined by rating three assessment videos, when they had to pass 70% or above accuracy rate to be invited to join the study. 2. Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996). BDI-II is a widely used measurement for the depressive level. It is a 21-item questionnaire with items of affective, cognitive, behavioural, and somatic symptoms of depression. The cut-off ranges are 0-3, 14-19, 20-28, and 29-63 representing a normal, mild, moderate and severe range of level of depressive symptoms respectively. The BDI-II has strong psychometric properties, with an excellent internal consistency of in psychiatric outpatients (a = .92) and in college stud

Secondary

MeasureTime frame
1. Cognitive Distortion Questionnaires (Adult Version) (CDQ-A) were modified from the children version (CDQ; Leung & Poon, 2001). For CDQA, 36 items were modified from CDQ. It is a self-report questionnaire; each item contains a vignette describing a negative life event and an automatic negative thought. Participants were asked about how their negative automatic thoughts were similar to theirs on a 5-point Likert scale. Three main types of cognitive distortions are included, namely, personalization, catastrophizing, and external attribution. The automatic negative thoughts were devised around depression and anxiety. For example, vignettes relating to depression recalled events of loss and failure, while vignettes relating to anxiety described events of threat and danger. There are six subscales in CDQA including depressive personalization, depressive catastrophizing, depressive externalization, anxiety personalization, anxiety catastrophizing, and anxiety externalization. Each of the six subscales has six items. 2. A CBT Knowledge Acquisition Questionnaire (CKQ) was developed. For CKQ, there are 22 true-or -false items selected from the true and false items of Unified Protocol Workbook (Barlow, Farchione, Fairholme, Ellard, Boisseau, Allen, & May, 2010). Those 22 items test CBT knowledge of each treatment modules. The items are related to nature of emotion, cognitive theory of emotion, emotion-driven behaviour and so on. Participants are asked to choose either true or false in each statement. Since every item represents a different construct, accurate items are added up as the sum of the score. 3. Reasoning of Mood Disorders (RMD) is developed to measure understanding of the etiology of common mental disorders. Its development references to an instrument called “Reason for Depression”(RFD; Addis, Truax, & Jacobson, 1995). RMD comprised of 15 items which are originally designed from three constructs to perceive the reasoning of suffering from common mental heal

Countries

Hong Kong SAR China

Contacts

Public ContactCandice Ling Yuet Man POWELL

Mind Hong Kong

candice.powell@mind.org.hk+852 93884387

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026