Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)

April 11, 2017 updated by: Suzanne Meeks, University of Louisville

BE-ACTIV: Treating Depression in Nursing Homes

This study will evaluate whether a behavioral activities treatment program improves symptoms of depression in nursing home residents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.

Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nursing home residents in long-term care beds with an expected stay of 3 months or more
  • Geriatric Depression Scale score of at least 11
  • Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder

Exclusion Criteria:

  • Mini Mental State Exam score below 14
  • Referred to hospice care for a terminal condition
  • Current unstable or terminal medical condition
  • Suicidal
  • Meets DSM-IV criteria for bipolar disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Participants will receive the BE-ACTIV treatment
Behavioral: BE-ACTIV
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
Active Comparator: B
Participants will receive treatment as usual
Behavioral: Treatment as usual (TAU)
TAU includes usual treatment in nursing care facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Staff attention
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Positive affect
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Activity participation
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Behavior problems
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48
Resident satisfaction
Time Frame: Measured at Weeks 12, 24, and 48
Measured at Weeks 12, 24, and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Suzanne Meeks, PhD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH074865 (U.S. NIH Grant/Contract)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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