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Reducing Depression in Dementia Caregivers

Phase 1
Completed
Conditions
Depression
Interventions
Behavioral: Basic Education
Registration Number
NCT00056316
Lead Sponsor
University of Missouri, St. Louis
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
74
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Basic EducationBasic EducationParticipants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
Primary Outcome Measures
NameTimeMethod
Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)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.

Beck Depression Inventory II (Beck, Steer & Brown, 1996)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.

Secondary Outcome Measures
NameTimeMethod
Negative Affect Schedule (Watson, Clark & Tellegen, 1988)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)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.

Trial Locations

Locations (1)

University of Missouri-St. Louis

🇺🇸

St. Louis, Missouri, United States

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