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Multidomain Intervention for Older Adults With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Supportive therapy
Multidomain intervention
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Community, Depressive Symptoms, Mental Health Program, Older adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Supportive therapy

Multidomain intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale(MADRS)
Change from baseline depressive symptoms at 4, 8, 12 weeks

Secondary Outcome Measures

resting-state fMRI
brain functional connectivity

Full Information

First Posted
March 21, 2017
Last Updated
August 21, 2018
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03095820
Brief Title
Multidomain Intervention for Older Adults With Major Depressive Disorder
Official Title
A 12-week Multidomain Intervention With Contingency Management for Older Adults With Major Depressive Disorder: A Community-based Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Community, Depressive Symptoms, Mental Health Program, Older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled parallel-design study
Masking
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.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multidomain intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy
Intervention Type
Behavioral
Intervention Name(s)
Multidomain intervention
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale(MADRS)
Description
Change from baseline depressive symptoms at 4, 8, 12 weeks
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
resting-state fMRI
Description
brain functional connectivity
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of non-psychotic, unipolar major depressive disorder, based on the Mini-International Neuropsychiatric Interview a Montgomery-Asberg Depression Rating Scale (MADRS) score of 17 or higher 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: a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia) 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 a history of significant hearing or visual impairment a history of physical illnesses that could interfere with the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Joon Son, MD,PhD
Organizational Affiliation
Ajou Univeristy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyunggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31969275
Citation
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.
Results Reference
derived

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Multidomain Intervention for Older Adults With Major Depressive Disorder

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