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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00536406
First received: September 25, 2007
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: BE-ACTIV
Behavioral: Treatment as usual (TAU)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BE-ACTIV: Treating Depression in Nursing Homes

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Functioning as assessed by the Dartmouth COOP Scales for Social Functioning [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Staff attention [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Positive affect [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Activity participation [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Behavior problems [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Resident satisfaction [ Time Frame: Measured at Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2007
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536406

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Suzanne Meeks, PhD University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00536406     History of Changes
Other Study ID Numbers: R01 MH074865, R01MH074865, DATR A4-GPS
Study First Received: September 25, 2007
Last Updated: April 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Louisville:
Geriatric
Nursing Homes

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014