行為激活對輕微抑鬱的療效研究
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Reduction of self-reported depressive symptoms
Study Overview
Brief Summary
行為激活對輕微抑鬱的療效
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- Single
Eligibility Criteria
- Ages
- 18 to — (—)
- Sex
- All
Inclusion Criteria
- •Aged 18 years or above;
- •Score 5-9 by Patient Health Questionnaire depression scale (PHQ-9).
Exclusion Criteria
- •major depression within the past 6 months;
- •lifetime history of other psychiatric disorders including generalized anxiety disorder, psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live;
- •patients who are receiving current treatment (taking antidepressants or other psychotropic medications or enrolled in any form of psychological interventions) for any depressive disorders or symptoms.
Arms & Interventions
Behavioral Activation
Behavioural activation: The Martell and Colleagues 2010 protocol will be used for the content of group BA intervention due to its established efficacy. 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.
Behavioral Activation (to be continued)
Specific content of the group BA will include psychoeducation with respect to well-being, setting both short and long term goals, the self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood,
Care As Usual
Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.
Care As Usual (to be continued)
All participants will be informed that their health care utilization, including their visits and use of medications will be recorded using the electronic patient record systems.
Outcomes
Primary Outcomes
Reduction of self-reported depressive symptoms
Time Frame: Assessments with the outcome measures will take place at baseline, two, five months (3 months after intervention) and 1 year.
Secondary Outcomes
- Incidence of DSM-IV major depression(1 year)
- Improvement in quality of life(measured at baseline, two, five months (3 months after intervention) and 1 year.)
- Utilization of health services including visits to primary care doctors(measured at baseline, two, five months (3 months after intervention) and 1 year.)
- activity change and circumstantial change(measured at baseline, two, five months (3 months after intervention) and 1 year.)
- patients to rate their impairment in 3 life domains including work, social and family/home management(measured at baseline, two, five months (3 months after intervention) and 1 year.)
- Anxiety symptoms(measured at baseline, two, five months (3 months after intervention) and 1 year)
- Satisfaction with delivered care(measured at baseline, two, five months (3 months after intervention) and 1 year)
- Quality-adjusted life years(measured at baseline, two, five months (3 months after intervention) and 1 year)