Clinical trial NCT00396825: Video-Based Coping Skills Training for Caregivers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Caregivers
Keywords: Care giving
Alzheimer's Disease
Stress management
Lead sponsor: Williams LifeSkills
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2006-11-08
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Center for Epidemiological Studies Depression scale
timeFrame: Pre- and post-training, 3 months and 6 months
measure: Spielberger State-Trait Anger and Anxiety Scales
timeFrame: Pre-and post-training, 3 months and 6 months
measure: Perceived Stress Scale
timeFrame: Pre- and post-training, 3 months and 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre-and post-training, 3 months and 6 months
measure: Heart rate and blood pressure at rest and during recall of caregiver situation
timeFrame: Pre-and post-training, 3 months and 6 months
measure: Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night
timeFrame: Pre-and post-training, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Williams LifeSkills, Inc.
state: North Carolina
Study officials:
affiliation: Williams LifeSkills
name: Virginia P Williams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams VP, Bishop-Fitzpatrick L, Lane JD, Gwyther LP, Ballard EL, Vendittelli AP, Hutchins TC, Williams RB. Video-based coping skills to reduce health risk and improve psychological and physical well-being in Alzheimer's disease family caregivers. Psychosom Med. 2010 Nov;72(9):897-904. doi: 10.1097/PSY.0b013e3181fc2d09. Epub 2010 Oct 26.