This trial is active, not recruiting.

Condition depression
Treatments be-activ, treatment as usual (tau)
Phase phase 2
Sponsor University of Louisville
Collaborator National Institute of Mental Health (NIMH)
Start date August 2007
End date July 2013
Trial size 140 participants
Trial identifier NCT00536406, DATR A4-GPS, R01 MH074865, R01MH074865


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Participants will receive the BE-ACTIV treatment
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
(Active Comparator)
Participants will receive treatment as usual
treatment as usual (tau)
TAU includes usual treatment in nursing care facility.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title BE-ACTIV: Treating Depression in Nursing Homes
Principal investigator Suzanne Meeks, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Louisville.