Reducing Depression in Dementia Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Missouri, St. Louis
ClinicalTrials.gov Identifier:
NCT00056316
First received: March 10, 2003
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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).


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 University of Missouri, St. Louis:

Primary Outcome Measures:
  • 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 ]
    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.

  • 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 ]
    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.


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 ]
    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.

  • 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 ]
    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.


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:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Missouri, St. Louis
Investigators
Principal Investigator: Ann M. Steffen, PhD 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 MH061956, R21MH061956, DSIR AT-GS
Study First Received: March 10, 2003
Results First Received: October 23, 2008
Last Updated: June 4, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Missouri, St. Louis:
Caregiving
Dementia
Alzheimer's
Depression
Technology
Treatment

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

ClinicalTrials.gov processed this record on October 29, 2014