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Completed

NCT Number: NCT00396825

Video-Based Coping Skills Training for Caregivers

The purpose of this Phase II SBIR study is a) to complete the adaptation begun in Phase I of the ten skill modules of the Williams LifeSkills Video (WLV) for use by persons who are caregivers for a relative with Alzheimer's Disease (AD) or other dementia, b) to script and produce the complete Caregiver LifeSkills Video (CLV) and c) to conduct a randomized clinical trial of the completed CLV to document benefits in terms of reduced psychosocial distress, reduced biomarkers of stress and improved well being.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Williams LifeSkills, Inc.

Durham, North Carolina, 27705, United States

About this study

An extensive body of research documents adverse effects of being a caregiver for a relative with AD on a broad range of psychosocial and biological indicators of stress, including increased hassles and depression (Russo & Vitaliano, Experimental Aging Research 1995; 21:273-294 ) and the metabolic syndrome (Vitaliano et al, Journal of Gerontology: Psychological Sciences 1996; 51:290-299). Interventions to reduce psychological distress in caregivers have not produced clinically meaningful results thus far (Shulz et al. Gerontologist 2002; 42:589-602) and no intervention trials have included assessment of biomarkers of stress. Logistic obstacles make it hard for caregivers to participate in treatments that require them to come to a treatment site outside the home; thus, interventions with caregivers are hard to deliver. The Williams LifeSkills Video (WLV) is based on the LifeSkills Workshop, which has been shown in randomized clinical trials to reduce hostility and blood pressure in post-MI patients (Gidron et al. Health Psychology 1999; 18:416-420) and to reduce a broad range of psychosocial risk factors as well as blood pressure and heart rate during both rest and stress conditions in post-CABG patients (Bishop et al., American Heart Journal 2005;150:602-609). The WLV was developed with support from an NIMH SBIR Phase II grant and presents 10 skill modules -- 1) increased awareness of thoughts and feelings arising in stressful situations; 2) evaluation of those thoughts and feelings to decide whether to try to change them or to take action to try to change the situation; 3) deflection skills to change one's thoughts and feelings; action skills to change stressful situations, including 4) assertion, 5) problem-solving, and 6) saying no; and relationship skills - 7) speaking clearly, 8) listening, 9) empathy, and 10) increasing the positives - using dramatizations of scenarios in which the skill is first not used and then used to produce a better outcome. A randomized clinical trial evaluating it in stressed community volunteers showed that it is superior to a wait list control condition in reducing psychosocial (anxiety, depression and perceived stress; (Kirby et al.Psychosomatic Medicine,2006;68:816-823.

In the research conducted in Phase I of this SBIR-supported study, we adapted the scenarios used for the 10 skills to represent more closely the real life situations faced by caregivers and we developed a telephone coaching manual. Now in Phase II of this study, we will produce the complete Caregiver LifeSkills Video (CLV) evaluate its effects on measures of psychosocial distress and biomarkers of stress in a randomized clinical trial with 120 caregivers of a relative with AD or other major dementias. If successful in reducing the psychosocial and biological markers of stress that are elevated in caregivers, this new WLS product, the CLV, could have a major impact in reducing the health damaging effects of stress among the millions of Americans who are caregivers for relatives with AD and other dementias.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be a primary caregiver for a relative with Alzheimer's Disease or other dementia

Exclusion criteria

  • Presence of a major medical or psychiatric illness that would prevent completion of low risk study procedures

Treatment and study plan

Video-based coping skills training with telephone coaching

Behavioral

Subjects will view the 10 modules of Williams LifeSkills Caregiver Video, do Workbook exercises for each module, and receive telephone coaching to enhance their ability to apply the skills taught in each module to caregiver situations.

Other names: Williams LifeSkills Family Caregiver Kit

Primary outcomes

  1. Center for Epidemiological Studies Depression scale

    Time frame: Pre- and post-training, 3 months and 6 months

  2. Spielberger State-Trait Anger and Anxiety Scales

    Time frame: Pre-and post-training, 3 months and 6 months

  3. Perceived Stress Scale

    Time frame: Pre- and post-training, 3 months and 6 months

  4. Pittsburgh Sleep Quality Index

    Time frame: Pre-and post-training, 3 months and 6 months

  5. Heart rate and blood pressure at rest and during recall of caregiver situation

    Time frame: Pre-and post-training, 3 months and 6 months

  6. Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night

    Time frame: Pre-and post-training, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Williams LifeSkills

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Phase II Trial of a Video That Presents Training in Stress Coping Skills for Caregivers of a Relative With Alzheimer's Disease or Other Dementia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 8, 2006
Registry last updated
Aug 13, 2012

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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