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Completed

NCT Number: NCT00536406

Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40292, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BE-ACTIV

Behavioral

BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.

Treatment as Usual (TAU)

Behavioral

TAU includes usual treatment in nursing care facility.

Primary outcomes

  1. Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale

    Time frame: Measured at Weeks 12, 24, and 48

  2. Functioning as assessed by the Dartmouth COOP Scales for Social Functioning

    Time frame: Measured at Weeks 12, 24, and 48

Secondary outcomes

  1. Staff attention

    Time frame: Measured at Weeks 12, 24, and 48

  2. Positive affect

    Time frame: Measured at Weeks 12, 24, and 48

  3. Activity participation

    Time frame: Measured at Weeks 12, 24, and 48

  4. Behavior problems

    Time frame: Measured at Weeks 12, 24, and 48

  5. Resident satisfaction

    Time frame: Measured at Weeks 12, 24, and 48

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

BE-ACTIV: Treating Depression in Nursing Homes

Acronym: BE-ACTIV

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2007
Registry last updated
Apr 13, 2017

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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