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

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CBCT

EFCT

Control

Arm Description

Cognitive behavioural couple therapy (CBCT), 5-session

Emotion focused couple therapy (EFCT), 5-session

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change from Baseline Dyadic Adjustment Scale at 2 months (post-intervention) and 8 months (6 months after intervention)
To evaluate 4 dimensions of marital quality of the participants (Consensus, Cohesion, Satisfaction and Affectional Expression). The range of the scale is 0 to 151. Lower total scores indicate greater distress in marital relationships. The 15 items of Consensus are rated on a 6-point scale from 0 (totally agree) to 5 (totally disagree). Two of the 6 items of Cohesion are rated on a 5-point scale from 0 (daily/all) to 4 (never) while the remaining 4 items on a 6-point scale from 0 (never) to 5 (always). Seven of the 9 items of Satisfaction are rated on a 6-point scale from 0 (anytime) to 5 (never) while one of the remaining items asked the participants to describe their marriage from 7 choices from "extremely unhappy" to "perfect". The last item included 6 sentences about views on the marital relationships and the participants are asked to choose the best one describing their thoughts. The 2 items of Affectional Expression are answered by "yes" or "no".
Change from Baseline Marital Satisfaction with Life Scale at 2 months (post-intervention) and 8 months (6 months after intervention)
To measure the subjective evaluation of one's satisfaction in life. The 5 items are rated on a 7-point scale from 1(strongly disagree) to 7(strongly agree). The range of the scale is 5 to 35. Higher scores represent greater life satisfaction.
Change from Baseline Difficulties in Emotion Regulation Scale-Short Form at 2 months (post-intervention) and 8 months (6 months after intervention)
To assess individuals' emotion dysregulation patterns. The 18 items are rated on a 5-point scale from 1 (almost never) to 5 (almost always). The range of the scale is 18 to 90. Higher scores indicate greater emotion dysregulation.
Change from Baseline Relationship Belief Inventory at 2 months (post-intervention) and 8 months (6 months after intervention)
To measure unrealistic beliefs about marriage of the participants. The 40 items are rated on 6-point scale from 0 (strongly believe the statement is false) to 5 (strongly believe the statement is true). The range of the scale is 0 to 200. Higher scores indicate a greater adherence to the related beliefs in marriage.

Full Information

First Posted
October 4, 2020
Last Updated
May 19, 2022
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong, City University of Hong Kong, York University
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1. Study Identification

Unique Protocol Identification Number
NCT04590573
Brief Title
Cognitive Behavioural Couple Intervention Therapy for Chinese Couples With a Depressed Partner
Official Title
The Effects of Cognitive-behaviour Couple Therapy and Emotionally Focused Couple Therapy for Chinese Couples With a Depressed Partner in Hong Kong: A Comparison to a Social Activity Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong, City University of Hong Kong, York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBCT
Arm Type
Experimental
Arm Description
Cognitive behavioural couple therapy (CBCT), 5-session
Arm Title
EFCT
Arm Type
Experimental
Arm Description
Emotion focused couple therapy (EFCT), 5-session
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Social activity wait-list groups (Control), 5-session
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Patient Health Questionnaire-9 at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
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.
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Title
Change from Baseline Depression Anxiety Stress Scales-Chinese Version at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
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.
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Secondary Outcome Measure Information:
Title
Change from Baseline Dyadic Adjustment Scale at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
To evaluate 4 dimensions of marital quality of the participants (Consensus, Cohesion, Satisfaction and Affectional Expression). The range of the scale is 0 to 151. Lower total scores indicate greater distress in marital relationships. The 15 items of Consensus are rated on a 6-point scale from 0 (totally agree) to 5 (totally disagree). Two of the 6 items of Cohesion are rated on a 5-point scale from 0 (daily/all) to 4 (never) while the remaining 4 items on a 6-point scale from 0 (never) to 5 (always). Seven of the 9 items of Satisfaction are rated on a 6-point scale from 0 (anytime) to 5 (never) while one of the remaining items asked the participants to describe their marriage from 7 choices from "extremely unhappy" to "perfect". The last item included 6 sentences about views on the marital relationships and the participants are asked to choose the best one describing their thoughts. The 2 items of Affectional Expression are answered by "yes" or "no".
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Title
Change from Baseline Marital Satisfaction with Life Scale at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
To measure the subjective evaluation of one's satisfaction in life. The 5 items are rated on a 7-point scale from 1(strongly disagree) to 7(strongly agree). The range of the scale is 5 to 35. Higher scores represent greater life satisfaction.
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Title
Change from Baseline Difficulties in Emotion Regulation Scale-Short Form at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
To assess individuals' emotion dysregulation patterns. The 18 items are rated on a 5-point scale from 1 (almost never) to 5 (almost always). The range of the scale is 18 to 90. Higher scores indicate greater emotion dysregulation.
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Title
Change from Baseline Relationship Belief Inventory at 2 months (post-intervention) and 8 months (6 months after intervention)
Description
To measure unrealistic beliefs about marriage of the participants. The 40 items are rated on 6-point scale from 0 (strongly believe the statement is false) to 5 (strongly believe the statement is true). The range of the scale is 0 to 200. Higher scores indicate a greater adherence to the related beliefs in marriage.
Time Frame
Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Neurological disease or damage that would compromise cognitive functioning Suicidal attempts or ideation in the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu Keung Daniel Wong, PhD
Phone
(+852) 3917 2287
Email
dfkwong@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fu Keung Daniel Wong, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu Keung Daniel Wong, PhD
Phone
(+852) 3917 2287
Email
dfkwong@hku.hk
First Name & Middle Initial & Last Name & Degree
Fu Keung Daniel Wong, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a platform for data sharing in the university
IPD Sharing Time Frame
after the research project is completed
IPD Sharing Access Criteria
based on the policy of the university
IPD Sharing URL
https://libguides.lib.hku.hk/researchdata/datahub

Learn more about this trial

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

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