Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents

NCT ID: NCT00536406

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Participants will receive the BE-ACTIV treatment

Group Type EXPERIMENTAL

BE-ACTIV

Intervention Type BEHAVIORAL

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

B

Participants will receive treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

TAU includes usual treatment in nursing care facility.

Interventions

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BE-ACTIV

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

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

TAU includes usual treatment in nursing care facility.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Meeks

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Meeks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH074865

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR A4-GPS

Identifier Type: -

Identifier Source: secondary_id

R01MH074865

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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