Reducing Depression in Dementia Caregivers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Depression in Dementia Caregivers

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Basic Education
* Behavioral: Behavioral Skills Training: Experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Skills Training<br>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<br>* Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.<br>|
| Active Comparator: Basic Education<br>Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member. | Behavioral: Basic Education<br>* Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention | 
| 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. | Post-intervention, assessed 4-14 days after final intervention session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention | 
| 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. | Post-intervention, assessed 4-14 days after final intervention session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiving, Dementia, Alzheimer's, Depression, Technology, Treatment