NCT00536406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

5.9 years

First QC Date

September 25, 2007

Last Update Submit

April 11, 2017

Conditions

Depression

Keywords

GeriatricNursing Homes

Outcome Measures

Primary Outcomes (2)

  • Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale

    Measured at Weeks 12, 24, and 48

  • Functioning as assessed by the Dartmouth COOP Scales for Social Functioning

    Measured at Weeks 12, 24, and 48

Secondary Outcomes (5)

  • Staff attention

    Measured at Weeks 12, 24, and 48

  • Positive affect

    Measured at Weeks 12, 24, and 48

  • Activity participation

    Measured at Weeks 12, 24, and 48

  • Behavior problems

    Measured at Weeks 12, 24, and 48

  • Resident satisfaction

    Measured at Weeks 12, 24, and 48

Study Arms (2)

A

EXPERIMENTAL

Participants will receive the BE-ACTIV treatment

Behavioral: BE-ACTIV

B

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual (TAU)

Interventions

BE-ACTIVBEHAVIORAL

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

A
Treatment as usual (TAU)BEHAVIORAL

TAU includes usual treatment in nursing care facility.

B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Suzanne Meeks, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)