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

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ClinicalTrials.gov Identifier: NCT04590573
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Chinese University of Hong Kong
City University of Hong Kong
York University
Information provided by (Responsible Party):
Professor Daniel Fu-Keung Wong, The University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Cognitive Behavioural Couple Therapy Model for Chinese Couples With a Partner With Depression in Hong Kong: A Comparison to Emotion Focused Couple Therapy and a Waitlist Control Condition
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CBCT
Cognitive behavioural couple therapy (CBCT), 5-session
 Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
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.
Experimental: EFCT
Emotion focused couple therapy (EFCT), 5-session
 Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
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.
Active Comparator: Control
Social activity wait-list groups (Control), 5-session
 Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Patient Health Questionnaire-9 at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]
    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.

  2. Change from Baseline Depression Anxiety Stress Scales-Chinese Version at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]
    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 :
  1. Change from Baseline Dyadic Adjustment Scale at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]

    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".


  2. Change from Baseline Marital Satisfaction with Life Scale at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]
    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.

  3. Change from Baseline Difficulties in Emotion Regulation Scale-Short Form at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]
    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.

  4. Change from Baseline Relationship Belief Inventory at 2 months (post-intervention) and 8 months (6 months after intervention) [ Time Frame: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590573


Contacts
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Contact: Fu Keung Daniel Wong, PhD (+852) 3917 2287 dfkwong@hku.hk

Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Contact: Fu Keung Daniel Wong, PhD    (+852) 3917 2287    dfkwong@hku.hk   
Principal Investigator: Fu Keung Daniel Wong, PhD         
Sponsors and Collaborators
The University of Hong Kong
Chinese University of Hong Kong
City University of Hong Kong
York University
Investigators
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Principal Investigator: Fu Keung Daniel Wong, PhD The University of Hong Kong
More Information
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Responsible Party: Professor Daniel Fu-Keung Wong, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04590573    
Other Study ID Numbers: CBCT
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a platform for data sharing in the university
Time Frame: after the research project is completed
Access Criteria: based on the policy of the university
URL: https://libguides.lib.hku.hk/researchdata/datahub

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms