Multidomain Intervention for Older Adults With Major Depressive Disorder

A 12-week Multidomain Intervention With Contingency Management for Older Adults With Major Depressive Disorder: A Community-based Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Supportive therapy; Behavioral: Multidomain intervention

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
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Suwon, Gyunggi-do, Korea, Republic of, 16499
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale(MADRS)	Change from baseline depressive symptoms at 4, 8, 12 weeks	Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resting-state fMRI	brain functional connectivity	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Sang Joon Son, MD,PhD, Ajou Univeristy School of Medicine

Publications and helpful links

General Publications

• Roh HW, Hong CH, Lim HK, Chang KJ, Kim H, Kim NR, Choi JW, Lee KS, Cho SM, Park B, Son SJ. A 12-week multidomain intervention for late-life depression: a community-based randomized controlled trial. J Affect Disord. 2020 Feb 15;263:437-444. doi: 10.1016/j.jad.2019.12.013. Epub 2019 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Older adults; Depressive Symptoms; Community; Mental Health Program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: AJIRB-SBR-SUR-15-132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No