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Completed

NCT Number: NCT00056316

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Missouri-St. Louis

St Louis, Missouri, 63121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic Education

Behavioral

Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.

Behavioral Skills Training: Experimental

Behavioral

Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri, St. Louis

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Mar 11, 2003
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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