CaregiversPhase 2NCT00396825
Video-Based Coping Skills Training for Caregivers
A Phase 2 study testing Video-based coping skills training with telephone coaching in people with Caregivers, run by Williams LifeSkills at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- Video-based coping skills training with telephone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be a primary caregiver for a relative with Alzheimer's Disease or other dementia
Who cannot join
- Presence of a major medical or psychiatric illness that would prevent completion of low risk study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Williams LifeSkills, Inc.
Durham, North Carolina, 27705
About this study
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
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.
Read the 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.
- Conditions
- Caregivers
- Being tested
- Video-based coping skills training with telephone coaching
- Keywords
- Care giving, Alzheimer's Disease, Stress management
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based coping skills training with telephone coachingBehavioural
Also called Williams LifeSkills Family Caregiver Kit
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.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Subjects randomized to this arm will receive the Family Caregiver Kit composed of the Williams LifeSkills Family Caregiver Video and Workbook and will also receive telephone coaching Receives: Behavioral: Video-based coping skills training with telephone coaching |
| Control | No intervention | Subjects randomized to this arm will receive no intervention and serve as wait list controls. They will undergo the same evaluations as the Intervention arm subjects at comparable times. In a crossover design, once subjects have finished serving as controls, they will be given the video, workbook, and telephone calls from a social worker and tested one more time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies Depression scale
Measured: Pre- and post-training, 3 months and 6 months
Spielberger State-Trait Anger and Anxiety Scales
Measured: Pre-and post-training, 3 months and 6 months
Perceived Stress Scale
Measured: Pre- and post-training, 3 months and 6 months
Pittsburgh Sleep Quality Index
Measured: Pre-and post-training, 3 months and 6 months
Heart rate and blood pressure at rest and during recall of caregiver situation
Measured: Pre-and post-training, 3 months and 6 months
Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night
Measured: Pre-and post-training, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Williams LifeSkills
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Virginia P. Williams, Ph.D., Williams LifeSkills
- Investigators
- Virginia P Williams, Ph.D., Principal investigator, Williams LifeSkills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396825
- Sponsor's protocol ID
- 2R44AG025593-04A;
- Other IDs
- 2R44AG025593
- Status last verified
- Aug 2012
- First submitted
- 6 Nov 2006
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20978227
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00396825
- Acronym / sponsor ID
- 2R44AG025593-04A;
- Conditions
- Caregivers
- Keywords
- Care giving, Alzheimer's Disease, Stress management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Williams LifeSkillsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Behavioral: Video-based coping skills training with telephone coachingSubjects randomized to this arm will receive the Family Caregiver Kit composed of the Williams LifeSkills Family Caregiver Video and Workbook and will also receive telephone coaching |
| Control | No intervention | –Subjects randomized to this arm will receive no intervention and serve as wait list controls. They will undergo the same evaluations as the Intervention arm subjects at comparable times. In a crossover design, once subjects have finished serving as controls, they will be given the video, workbook, and telephone calls from a social worker and tested one more time. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a primary caregiver for a relative with Alzheimer's Disease or other dementia
Key exclusion criteria (1 listed)
- Presence of a major medical or psychiatric illness that would prevent completion of low risk study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based coping skills training with telephone coachingAlso: Williams LifeSkills Family Caregiver KitSubjects 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. | Behavioural | Active treatment |
Primary outcome
Center for Epidemiological Studies Depression scale
Time frame: Pre- and post-training, 3 months and 6 months
Spielberger State-Trait Anger and Anxiety Scales
Time frame: Pre-and post-training, 3 months and 6 months
Perceived Stress Scale
Time frame: Pre- and post-training, 3 months and 6 months
Pittsburgh Sleep Quality Index
Time frame: Pre-and post-training, 3 months and 6 months
Heart rate and blood pressure at rest and during recall of caregiver situation
Time frame: Pre-and post-training, 3 months and 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
- Derived from this study: PubMed 20978227Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia P Williams, Ph.D. principal investigator
Williams LifeSkills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Video-based coping skills training with telephone coaching in people with Caregivers, run by Williams LifeSkills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiological Studies Depression scale (time frame: Pre- and post-training, 3 months and 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2012.