We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Depression in Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00056316
Recruitment Status : Completed
First Posted : March 11, 2003
Results First Posted : November 19, 2008
Last Update Posted : June 23, 2014
Sponsor:
Collaborator:
Information provided by:

March 10, 2003
March 11, 2003
October 23, 2008
November 19, 2008
June 23, 2014
January 2002
August 2004   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Not Provided
Complete list of historical versions of study NCT00056316 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
Not Provided
 
Reducing Depression in Dementia Caregivers
Reducing Depression in Dementia Caregivers
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).
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: Basic Education
    Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
  • 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.
  • 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.
    Intervention: Behavioral: Behavioral Skills Training: Experimental
  • Active Comparator: Basic Education
    Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
    Intervention: Behavioral: Basic Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
August 2004
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00056316
R21MH061956( U.S. NIH Grant/Contract )
R21MH061956 ( U.S. NIH Grant/Contract )
DSIR AT-GS
Yes
Not Provided
Not Provided
Ann M. Steffen, Ph.D./Associate Professor of Psychology, University of Missouri-St. Louis
University of Missouri, St. Louis
National Institute of Mental Health (NIMH)
Principal Investigator: Ann M. Steffen, PhD University of Missouri, St. Louis
University of Missouri, St. Louis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP