Reducing Depression in Dementia Caregivers

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00056316
First received: March 10, 2003
Last updated: November 17, 2008
Last verified: November 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Depression in Dementia Caregivers

Resource links provided by NLM:


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
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.

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
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.

Responsible Party: Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis
ClinicalTrials.gov Identifier: NCT00056316     History of Changes
Other 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
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014