Reducing Depression in Dementia Caregivers

NCT ID: NCT00056316

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2004-08-31

Brief Summary

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).

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Skills Training: Experimental

Intervention Type: BEHAVIORAL

Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.

Basic Education

Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.

Group Type: ACTIVE_COMPARATOR

Basic Education

Intervention Type: BEHAVIORAL

Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.

Interventions

Basic Education

Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Missouri, St. Louis

OTHER

Sponsor Role: lead

Responsible Party

University of Missouri-St. Louis

Principal Investigators

Ann M. Steffen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, St. Louis

Locations

University of Missouri-St. Louis

St Louis, Missouri, United States

Countries

United States

References

Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.

Reference Type: BACKGROUND

Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.

Reference Type: BACKGROUND

PMID: 11773226 (View on PubMed)

Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.

Reference Type: DERIVED

PMID: 33417236 (View on PubMed)

Other Identifiers

R21MH061956

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-GS

Identifier Type: -

Identifier Source: secondary_id

R21MH061956

Identifier Type: NIH

Identifier Source: org_study_id

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