Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396825
Status:
COMPLETED
Last Update Posted:
2012-08-13
First Post:
2006-11-06
Brief Title:
Video-Based Coping Skills Training for Caregivers
Sponsor:
Williams LifeSkills
Organization:
Williams LifeSkills
Study Overview
Official Title:
Phase II Trial of a Video That Presents Training in Stress Coping Skills for Caregivers of a Relative With Alzheimers Disease or Other Dementia
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 21273-294 and the metabolic syndrome Vitaliano et al Journal of Gerontology Psychological Sciences 1996 51290-299 Interventions to reduce psychological distress in caregivers have not produced clinically meaningful results thus far Shulz et al Gerontologist 2002 42589-602 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 18416-420 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 2005150602-609 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 ones 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 alPsychosomatic Medicine200668816-823
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44AG025593 | NIH | None | httpsreporternihgovquickSearch2R44AG025593 |