DepressionNCT04590573
Cognitive Behavioural Couple Intervention Therapy for Chinese Couples With a Depressed Partner
A study of Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Neurological disease or damage that would compromise cognitive functioning
- Suicidal attempts or ideation in the past 3 months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Fu Keung Daniel Wong, PhD, (+852) 3917 2287, dfkwong@hku.hk
Fu Keung Daniel Wong, PhD
About this study
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
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.
Read more
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
- Being tested
- Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Experimental | Cognitive behavioural couple therapy (CBCT), 5-session Receives: Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control) |
| EFCT | Experimental | Emotion focused couple therapy (EFCT), 5-session Receives: 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 Receives: Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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".
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Day 0 (Baseline), Month 2 (Post-intervention), Month 8 (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, City University of Hong Kong, York University
- Responsible party
- Principal investigator, Professor Daniel Fu-Keung Wong, The University of Hong Kong
- Investigators
- Fu Keung Daniel Wong, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590573
- Sponsor's protocol ID
- CBCT
- Status last verified
- May 2022
- First submitted
- 4 Oct 2020
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a platform for data sharing in the university
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04590573
- Acronym / sponsor ID
- CBCT
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, City University of Hong Kong, York University
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBCT | Experimental | Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)Cognitive behavioural couple therapy (CBCT), 5-session |
| EFCT | Experimental | Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)Emotion focused couple therapy (EFCT), 5-session |
| Control | Active comparator | Behavioral: Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)Social activity wait-list groups (Control), 5-session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Neurological disease or damage that would compromise cognitive functioning
- Suicidal attempts or ideation in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBCT, Control, EFCT |
Primary outcome
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.
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Yes. There is a platform for data sharing in the university
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu Keung Daniel Wong, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu Keung Daniel Wong, PhD ((+852) 3917 2287, dfkwong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.