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

September 25, 2007
April 19, 2013
August 2007
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale [ Time Frame: 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 ]
Complete list of historical versions of study NCT00536406 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Staff attention [ Time Frame: Measured at Weeks 12, 24, and 48 ]
  • Positive affect [ Time Frame: Measured at Weeks 12, 24, and 48 ]
  • Activity participation [ Time Frame: Measured at Weeks 12, 24, and 48 ]
  • Behavior problems [ Time Frame: Measured at Weeks 12, 24, and 48 ]
  • Resident satisfaction [ Time Frame: Measured at Weeks 12, 24, and 48 ]
Not Provided
Not Provided
 
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: BE-ACTIV
    BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
  • Behavioral: Treatment as usual (TAU)
    TAU includes usual treatment in nursing care facility.
  • Experimental: A
    Participants will receive the BE-ACTIV treatment
    Intervention: Behavioral: BE-ACTIV
  • Active Comparator: B
    Participants will receive treatment as usual
    Intervention: Behavioral: Treatment as usual (TAU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
November 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536406
R01 MH074865, R01MH074865, DATR A4-GPS
Yes
University of Louisville
University of Louisville
National Institute of Mental Health (NIMH)
Principal Investigator: Suzanne Meeks, PhD University of Louisville
University of Louisville
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP