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Completed

NCT Number: NCT03095820

Multidomain Intervention for Older Adults With Major Depressive Disorder

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyunggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive Therapy

Behavioral

Multidomain intervention

Behavioral

Primary outcomes

  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 outcomes

  1. resting-state fMRI

    Time frame: Baseline, 12 weeks

    brain functional connectivity

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 30, 2017
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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