Cognitive Behavioural Couple Intervention Therapy for Chinese Couples With a Depressed Partner

NCT04590573 | Unknown

• 1 other identifier: CBCT
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Understanding depression from a relational perspective maybe more meaningful in Chinese culture due to the different values and beliefs among Chinese comparing to those of the Western cultures. The PI and his associates developed a Cognitive Behavioural Couple Therapy model for Chinese couples with a depressed partner receiving mental health services in a community mental health centre in Hong Kong between 2018 and 2019. With consideration of the limitations in a pilot study conducted by the PI, modifications are made in the current study. This study aims to evaluate the effectiveness of a cognitive behavioural couple therapy model for Chinese couples with a depressed partner in Hong Kong. A comparison approach involving cognitive behavioural couple therapy (CBCT), emotional focused couple therapy (EFCT) and a wait-list control group on their short-term and long-term effects, as well as differential benefits will be examined. A set of questionnaires will be filled out by the 135 participants (45 in each arm) before the intervention (T0), after the intervention (T1), and 6-month after the intervention (T2). It is hypothesized that comparing to the control group, participants in CBCT and EFCT conditions will have greater improvements in outcomes at T1 and T2. There will be differential therapeutic effects of CBCT and EFCT on the various outcomes. Different mediating effects behind the changes in the outcomes in the two conditions will be examined. The study will contribute to the current literature by evaluating the effectiveness of culturally-attuned CBCT and EFCT. New insights will be added to the current therapeutic approaches for couples with a depressed partner. A sets of questionnaires will be assessed before the intervention (T0), after the intervention (T1), and 6-month after the intervention (T2). It is hypothesized that comparing to the control group, participants in CBCT and EFCT conditions will have greater improvements in outcomes at T1 and T2. Also, they may receive differential therapeutic effects of CBCT and EFCT on different outcomes. Different mediating effects behind the changes in the outcomes will be examined. The study will contribute to the current literature by evaluating the effectiveness of culturally-attuned CBCT and EFCT. Insights may be provide to the current therapeutic approach for couples with depressed partners.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Patient Health Questionnaire-9 at 2 months (post-intervention) and 8 months (6 months after intervention)

  To assess frequency of depressive symptoms of the participants during the preceding 2 weeks. The 9 items are rated on a 3-point scale from 0 (not at all) to 3 (nearly every day). The range of the scale is 0 to 27. Higher scores indicated more depressive symptoms.

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

• Change from Baseline Depression Anxiety Stress Scales-Chinese Version at 2 months (post-intervention) and 8 months (6 months after intervention)

  To assess the emotional states of depression, anxiety and stress in the participants. The 21 items are rated on a 4-point scale from 0 (not applicable) to 3 (very applicable). Sum scores are computed by adding up the scores of each item and then multiplying by 2. The range of the scale is from 0 to 120. Higher scores indicated higher levels of depression, anxiety and stress.

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

Secondary Outcomes (4)

• Change from Baseline Dyadic Adjustment Scale at 2 months (post-intervention) and 8 months (6 months after intervention)

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

• Change from Baseline Marital Satisfaction with Life Scale at 2 months (post-intervention) and 8 months (6 months after intervention)

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

• Change from Baseline Difficulties in Emotion Regulation Scale-Short Form at 2 months (post-intervention) and 8 months (6 months after intervention)

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

• Change from Baseline Relationship Belief Inventory at 2 months (post-intervention) and 8 months (6 months after intervention)

  Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

Study Arms (3)

CBCT

EXPERIMENTAL

Cognitive behavioural couple therapy (CBCT), 5-session

Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)

EFCT

EXPERIMENTAL

Emotion focused couple therapy (EFCT), 5-session

Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)

Control

ACTIVE COMPARATOR

Social activity wait-list groups (Control), 5-session

Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)

Interventions

Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control) BEHAVIORAL

5 sessions in CBCT, EFCT and Control (3 hours per session), 6-8 pairs of couples per group and around 7 groups will be held.

CBCT; Control; EFCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese couples aged 18 to 65
• Able to understand Cantonese or Chinese
• One of the couples having a diagnosis of DSM-V Major Depressive Disorder (MDD)

You may not qualify if:

• Neurological disease or damage that would compromise cognitive functioning
• Suicidal attempts or ideation in the past 3 months

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• City University of Hong Kong: collaborator
• York University: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Fu Keung Daniel Wong, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu Keung Daniel Wong, PhD

CONTACT

(+852) 3917 2287; dfkwong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 19, 2020
• Study Start: January 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: after the research project is completed
• Access Criteria: based on the policy of the university

Locations

HK (1)