Multidomain Intervention for Older Adults With Major Depressive Disorder

NCT03095820 | Completed

• 1 other identifier: AJIRB-SBR-SUR-15-132
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Community; Depressive Symptoms; Mental Health Program; Older adults

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale(MADRS)

  Change from baseline depressive symptoms at 4, 8, 12 weeks

  Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (1)

• resting-state fMRI

  Baseline, 12 weeks

Study Arms (2)

Supportive therapy

ACTIVE COMPARATOR

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

Multidomain intervention

EXPERIMENTAL

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

Interventions

Supportive therapy BEHAVIORAL

Supportive therapy

Multidomain intervention BEHAVIORAL

Multidomain intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyunggi-do, 16499, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31969275 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sang Joon Son, MD,PhD

  Ajou Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled parallel-design study

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 30, 2017
• Study Start: March 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: January 31, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

KR (1)