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临床试验/NCT04590573
NCT04590573尚未招募不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
135
试验地点
1
主要终点
Change from Baseline Patient Health Questionnaire-9 at 2 months (post-intervention) and 8 months (6 months after intervention)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

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

时间窗: 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)

时间窗: 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.

次要结局

  • 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 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 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Daniel Fu-Keung Wong

Professor

The University of Hong Kong

研究点 (1)

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