Reducing Depression in Dementia Caregivers
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Basic Education
Behavioral Skills Training: Experimental
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Caregiving, Dementia, Alzheimer's, Depression, Technology, Treatment
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
Sites / Locations
- University of Missouri-St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral Skills Training
Basic Education
Arm Description
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Outcomes
Primary Outcome Measures
Beck Depression Inventory II (Beck, Steer & Brown, 1996)
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)
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)
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)
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.
Full Information
NCT ID
NCT00056316
First Posted
March 10, 2003
Last Updated
June 4, 2014
Sponsor
University of Missouri, St. Louis
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00056316
Brief Title
Reducing Depression in Dementia Caregivers
Official Title
Reducing Depression in Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Missouri, St. Louis
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Caregiving, Dementia, Alzheimer's, Depression, Technology, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Skills Training
Arm Type
Experimental
Arm Description
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Arm Title
Basic Education
Arm Type
Active Comparator
Arm Description
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Intervention Type
Behavioral
Intervention Name(s)
Basic Education
Intervention Description
Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Skills Training: Experimental
Intervention Description
Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
Primary Outcome Measure Information:
Title
Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Description
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.
Time Frame
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Title
Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)
Description
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.
Time Frame
Post-intervention, assessed 4-14 days after final intervention session.
Secondary Outcome Measure Information:
Title
Negative Affect Schedule (Watson, Clark & Tellegen, 1988)
Description
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.
Time Frame
Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention
Title
Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)
Description
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.
Time Frame
Post-intervention, assessed 4-14 days after final intervention session.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M. Steffen, PhD
Organizational Affiliation
University of Missouri, St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Steffen AM. Anger management for dementia caregivers: A preliminary study using video and telephone interventions. Behavior Therapy 31:281-299, 2000.
Results Reference
background
PubMed Identifier
11773226
Citation
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.
Results Reference
background
PubMed Identifier
33417236
Citation
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.
Results Reference
derived
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Reducing Depression in Dementia Caregivers
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