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CUHK_CCRB00595
2018-03-09
Prospective
CREC Ref No: 2017.486
N/A
The Jockey Club School of Public Health and Primary Care
N/A
Not Applicable
Aaroy CHAN
4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK
2252-8463
aaroy@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong
Prof. Samuel Yeung Shan WONG
4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK
2252-8774
yeungshanwong@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong
The effectiveness of group behavioural activation with mindfulness (BAM) in the treatment of depression in primary care in Hong Kong: A randomised controlled trial
The effectiveness of group behavioural activation with mindfulness (BAM) in the treatment of depression in primary care in Hong Kong: A randomised controlled trial
行為激活加靜觀對抑鬱的療效研究
BAM
Hong Kong
Yes
2018-01-19
Joint CUHK-NTEC Clinical Research Ethics Committee
2017.486
Depression
Behavior
The objective of the BA intervention is to identify, promote, and reinforce activities and circumstances that are consistent with each participant’s long-term goals. The specific contents of the intervention for the group BA will include psychoeducation with respect to well-being, setting both short and long-term goals, self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities, and identification of avoidance and its impact. The mindfulness component will be integrated with the BA components and will be used to increase the awareness of the relationship between activity and mood changes, including the awareness of avoidance behaviour, and its associated emotion and thoughts. The mindfulness component will also cultivate the development of non-judgmental acceptance of mood and thoughts, and self-compassion when difficult emotions arise owing to avoidance. The mindfulness component will be complementary to BA and only basic mindfulness skills will be taught to participants. These will include mindfulness of breath, sitting and walking meditation, and body scan.
Weekly two hour/session for 8 weeks
Two hour/session/week
8 weeks
Once per week
Participants in the CAU group will be allowed unrestricted access to medical care provided by general outpatient clinics for their depression. In Hong Kong, general outpatient clinics provide primary care services at a low subsidized fee and the integrated mental health program (IMHP) is the current program used in primary care to provide mental health care for people with clinically significant depressive symptoms (PHQ-9 score > 10). Participants assigned to the CAU will receive their usual mental health care from healthcare workers and doctors in the IMHP. Data on participants’ health care utilization will be collected, including those about their visits and use of medications, which will be recorded using the electronic patient record systems.
N/A
N/A
8 weeks
N/A
1) Aged 18 years or above
2) Screened by the Patient Health Questionnaire (PHQ-9) with a score of 10 or above
3) Screened positive for major depression using the Structured Clinical Interview for DSM-V (SCID)
1) Having a lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, the presence of serious suicidal risk or medical illness with a prognosis of less than 6 months to live
2) Currently receiving any psychotherapy including being enrolled in the integrated mental health program (IMHP) or was enrolled in the IMHP within the past 6 months
3) Having received any psychotherapy in the past 6 months; and 4) currently practising or has practiced meditation or enrolled in mindfulness based interventions during the past one year
18
999
Both Male and Female
Interventional
Randomized
Randomized two-armed intervention study
Not Applicable
Single-blind
Investigator/research team
Parallel
4
2018-03-19
158
Recruiting
Patient Health Questionnaire (PHQ-9)
Depression levels will be assessed by PHQ-9.
At 6 months (T2) post-randomisation
Patient Health Questionnaire (PHQ-9)
Depression levels will be assessed by PHQ-9.
At 2 months (T1) and 12 months (T3) post randomisation.
The Structured Clinical Interview for DSM-IV (SCID)
Semi-structured interview in clinical settings for detecting major DSM-IV Axis I diagnoses
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
Generalized Anxiety Disorder 7 item scale (GAD-7)
Anxiety level will be assessed by GAD-7.
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
Quality-adjusted life-year (QALY)
To measure the generic quality of life of participants in studies.
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
Cost effectiveness analysis
Cost of the intervention will be estimated from the societal perspective.
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
Activity and Circumstantial Change
Assess the extent to which participants experience both activity change and circumstantial change.
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
Health service utilization and medication use
Utilization of health services including visits to doctors or accident and emergency units, visits to any specialist outpatient clinics, use of other allied health services and hospitalizations, medications, and days of absence from work
Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.
2019-04-09
ChiCTR1800015151
2018-03-09
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