Reducing Depression in Dementia Caregivers - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00056316

Purpose

This study will identify effective treatments for reducing depression among female caregivers to patients with dementia.

Condition	Intervention	Phase
Depression	Behavioral: Basic Education Behavioral: Behavioral Skills Training: Experimental	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Reducing Depression in Dementia Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Dementia Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Time Frame: Post-intervention, assessed 4-14 days after final intervention session. ] [ Designated as safety issue: No ]
Beck Depression Inventory II (Beck, Steer & Brown, 1996) [ Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Negative Affect Schedule (Watson, Clark & Tellegen, 1988) [ Time Frame: Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention ] [ Designated as safety issue: No ]
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988) [ Time Frame: Post-intervention, assessed 4-14 days after final intervention session. ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	January 2002
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.
Basic Education: Active Comparator 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.

Detailed Description:

Caregivers to patients with dementia often experience some level of depression. This study will compare the effectiveness of two home based information and support treatments to reduce depressive episodes.

This study is for women who live with a family member with dementia and are experiencing stress related to caregiving. Caregivers are randomly assigned to either a psychoeducational intervention or to treatment as usual for 10 weeks. The psychoeducational group members receive written and videotaped material and weekly telephone contact with a mental health professional. After treatment, participants are evaluated for psychological distress. Participants are reassessed after 6 months.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056316

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Ann M. Steffen, Ph.D.

University of Missouri-St. Louis

More Information

Publications:

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

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.

Responsible Party:	University of Missouri-St. Louis ( Ann M. Steffen, Ph.D./Associate Professor of Psychology )
Study ID Numbers:	R21 MH61956, DSIR AT-GS
Study First Received:	March 10, 2003
Results First Received:	October 23, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00056316 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Dementia

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Depression
Mental Disorders
Nervous System Diseases
Mood Disorders

Central Nervous System Diseases
Brain Diseases
Dementia
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009