Reducing Depression in Dementia Caregivers

June 4, 2014 updated by: University of Missouri, St. Louis
The purpose of this study was to develop and examine the initial impact of a distance-based intervention for female family dementia caregivers. As stated in the original proposal, the primary hypothesis of the study was that family caregivers who participated in the Video Intervention would show greater reduction in psychological distress (i.e., on measures of depression and emotional distress following problematic patient behaviors) compared to those in the Basic Education condition, and that this effect would be maintained over time (3 and 6 months post-tx).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Family caregivers of individuals with dementia commonly report depressive symptoms, along with other forms of emotional distress. This study compared the effectiveness of two home-based interventions to reduce levels of depressed, anxious, and other negative moods in women living with a family member with dementia. Eligible caregivers were randomly assigned to participate in either a video/workbook/telephone coaching intervention, or to a basic education condition consisting of a workbook and supportive telephone calls. Participants were evaluated for psychosocial distress after treatment, and at 3- and 6-months following the end of intervention.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63121
        • University of Missouri-St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Caregiver and dementia pt live in the same home
  • Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI

Exclusion Criteria:

  • Insulin dependent diabetes
  • Thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Skills Training
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Behavioral: Behavioral Skills Training: Experimental
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Active Comparator: Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Behavioral: Basic Education
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Time Frame: Post-intervention, assessed 4-14 days after final intervention session.
21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.
Post-intervention, assessed 4-14 days after final intervention session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Affect Schedule (Watson, Clark & Tellegen, 1988)
Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
Time Frame: Post-intervention, assessed 4-14 days after final intervention session.
10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = "very slightly or not at all," and 5 = "extremely". The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion.
Post-intervention, assessed 4-14 days after final intervention session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, St. Louis

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ann M. Steffen, PhD, University of Missouri, St. Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 10, 2003

First Submitted That Met QC Criteria

March 10, 2003

First Posted (Estimate)

March 11, 2003

Study Record Updates

Last Update Posted (Estimate)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH061956 (U.S. NIH Grant/Contract)
  • DSIR AT-GS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Behavioral Skills Training: Experimental

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe