Video-Based Coping Skills Training for Caregivers

Caregivers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396825
• Other study ID #: 2R44AG025593-04A
• Secondary ID: 2R44AG025593
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2006
• Last updated: August 10, 2012
• Start date: January 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2012
• Source: Williams LifeSkills
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caregivers

Intervention

Behavioral:
• Video-based coping skills training with telephone coaching
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.

Locations

Country	Name	City	State
United States	Williams LifeSkills, Inc.	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Williams LifeSkills	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiological Studies Depression scale		Pre- and post-training, 3 months and 6 months	No
Primary	Spielberger State-Trait Anger and Anxiety Scales		Pre-and post-training, 3 months and 6 months	No
Primary	Perceived Stress Scale		Pre- and post-training, 3 months and 6 months	No
Primary	Pittsburgh Sleep Quality Index		Pre-and post-training, 3 months and 6 months	No
Primary	Heart rate and blood pressure at rest and during recall of caregiver situation		Pre-and post-training, 3 months and 6 months	No
Primary	Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night		Pre-and post-training, 3 months and 6 months	No