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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
Sponsor:
Information provided by (Responsible Party):
Sang Joon Son, Ajou University School of Medicine

Brief Summary:
To assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Supportive therapy Behavioral: Multidomain intervention Not Applicable

Detailed Description:

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. resting-state fMRI [ Time Frame: Baseline, 12 weeks ]
    brain functional connectivity



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. a diagnosis of non-psychotic, unipolar major depressive disorder, based on the Mini-International Neuropsychiatric Interview
  2. a Montgomery-Asberg Depression Rating Scale (MADRS) score of 17 or higher
  3. the use of antidepressants at stable dosage for at least 6 weeks prior to study entry, without any recommendation for changes in medication for the 12 weeks of the intervention. Pharmacotherapy was uncontrolled and was provided by physicians.

Exclusion Criteria:

  1. a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia)
  2. a history of neurological disorder, such as brain tumor, intracranial hemorrhage, subarachnoid hemorrhage, epilepsy, hydrocephalus, encephalitis, metabolic encephalopathy, or other neurologic conditions that could interfere with the study
  3. a history of significant hearing or visual impairment
  4. a history of physical illnesses that could interfere with the study.

Information from the National Library of Medicine

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


Locations
Korea, Republic of
Ajou University Hospital
Suwon, Gyunggi-do, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Sang Joon Son, MD,PhD Ajou Univeristy School of Medicine

Responsible Party: Sang Joon Son, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03095820     History of Changes
Other Study ID Numbers: AJIRB-SBR-SUR-15-132
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sang Joon Son, Ajou University School of Medicine:
Community
Depressive Symptoms
Mental Health Program
Older adults

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms