Clinical trial NCT03095820: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Community
Depressive Symptoms
Mental Health Program
Older adults
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel-design study
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale(MADRS)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: resting-state fMRI
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyunggi-do
Study officials:
affiliation: Ajou Univeristy School of Medicine
name: Sang Joon Son, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.