Multidomain Intervention for Older Adults With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03095820|
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Supportive therapy Behavioral: Multidomain intervention||Not Applicable|
Awareness of the necessity and importance of community-based multidomain psychosocial intervention for late-life depression has increased. However, few studies have attempted to integrate several therapeutic approaches in one intervention program.
Main objective of this study is to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.
We plan to conduct a randomized controlled parallel-design study. We plan to allocate study participants to multidomain intervention or supportive therapy group, in a 1:1 ratio. Block randomization using SAS (PLAN procedure) and sample size estimation were performed. We estimated that, with at least 40 participants per group and an attrition rate of 10%, we could achieve a power of at least 0.80 (beta = 0.2, two-tailed alpha = 0.05).
Intervention was based on the financial and human resources of a community mental health service, and involved four home visits and 12 telephone calls over 12 weeks. Four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the multidomain intervention program. To maintain participant motivation, we plan to apply contingency management based on operant conditioning theory.
The primary outcome is the change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondarily, we plan to investigate changes in resting-state functional connectivity in the default mode, salience, and central executive networks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled parallel-design study|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Due to the nature of the intervention, we were unable to blind the nurses performing the intervention. However, to achieve double blinding as rigorously as possible, group allocation was not divulged to participants, and symptoms were rated by independent psychologists unaware of the randomization status.|
|Official Title:||A 12-week Multidomain Intervention With Contingency Management for Older Adults With Major Depressive Disorder: A Community-based Randomized Clinical Trial|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||January 31, 2017|
Active Comparator: Supportive therapy
The control group received supportive therapy for 12 weeks. In addition to a telephone call once a week and a home visit once a month, this program consisted of identification of physical problems, encouragement of general exercise, encouragement of pleasant activities, and so forth. The control program did not feature any specific goal setting by the participants, specific education about the benefits of achievement of such goals, or symbolic prizes.
Behavioral: Supportive therapy
Experimental: Multidomain intervention
As a multidomain intervention, four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the program.
In terms of the healthy diet intervention, we encouraged participants to perform at least 30 min of above-moderate physical activity, three times per week. In terms of the healthy diet intervention, the intervention consisted of encouraging participants to consume high quantities of fish, olive oil, legumes, vegetables, and fruit, at a frequency of at least twice a week. In terms of the social activity intervention, we encouraged participants to participate in social organizations, such as the senior center, the hall of the elderly, a fraternity, a reunion, and a clan gathering, at least once a week. In terms of the emotional regulation intervention, we a performed brief cognitive restructuring task for 20 min per visit.
Behavioral: Multidomain intervention
- Montgomery-Asberg Depression Rating Scale(MADRS) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]Change from baseline depressive symptoms at 4, 8, 12 weeks
- resting-state fMRI [ Time Frame: Baseline, 12 weeks ]brain functional connectivity
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): NCT03095820
|Korea, Republic of|
|Ajou University Hospital|
|Suwon, Gyunggi-do, Korea, Republic of, 16499|
|Principal Investigator:||Sang Joon Son, MD,PhD||Ajou Univeristy School of Medicine|