Alzheimer DiseaseNCT02317523
Alzheimer's Caregiver Coping: Mental and Physical Health
A study testing Behavioral Activation and Information and Support in people with Alzheimer Disease and Alzheimer Dementia, run by University of California, San Diego at 1 site in United States.
Trial summary
This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Alzheimer Dementia, Alzheimer's Disease
- What is being tested?
- Behavioral Activation and Information and Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Jun 2019
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 years or older.
- Providing in-home care to a spouse with dementia.
Who cannot join
- Taking Coumarin anticoagulants.
- Taking nitrates or niacin.
- Taking non-selective β-blockers.
- Glucocorticoid use in the 2 weeks prior to enrollment.
- Taking Aldomet or labetalol.
- Neither the caregiver nor Alzheimer's patient can be diagnosed with a terminal illness with a life expectancy of less than 1 year
Show all 9Show fewer
- Cognitive impairment
- Caregivers enrolled in another intervention study or receiving psychotherapy to improve well-being or reduce distress
- Blood pressure >200/120 mm Hg
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.
Read the detailed description
The burden of caring for a loved-one with Alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. These consequences including risk for depression, cardiovascular disease, and earlier mortality. Because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease.
The investigators aims are to determine whether a 6-week Behavioral Activation (BA) intervention, followed by 3 booster sessions over a period of 6 months, compared to an Information-Support (IS) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.
- Conditions
- Alzheimer Disease, Alzheimer Dementia, Alzheimer's Disease, Dementia
- Being tested
- Behavioral Activation, Information and Support
- Keywords
- Dementia, Caregiver, Cardiovascular Disease, Stress, Depression, Anxiety, Heart Disease, Carer, Care Giver, Caregiving, Psychotherapy, Therapy, Behavioral Activation, Education, Intervention, CBT, Cognitive-Behavior Therapy
- Medical subject headings
- Alzheimer Disease, Dementia, Cardiovascular Diseases, Depression, Anxiety Disorders, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Information and SupportBehavioural
Six face-to-face sessions (60 minutes each) of Supportive Therapy
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral Activation (BA) emphasize self-monitoring as an aid for increasing one's engagement in self-reinforcing activities while simultaneously reducing negative avoidant coping responses. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each. Receives: Behavioral: Behavioral Activation |
| Information and Support | Active comparator | Information and Support (IS) consists of providing education on Alzheimer's disease, coping with specific stresses prevalent in caregiving, and community-based services available for caregivers. Caregivers choose information most relevant to their current circumstances, and can discuss this with their counselor during the sessions. In addition, the IS condition encompasses elements of supportive therapy including empathy and active listening. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each. Receives: Behavioral: Information and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent Flow Mediated Dilation (FMD)
Flow-Mediated Dilation
Measured: Change from baseline to 2-year follow-up
Center for Epidemiologic Studies - Depression (CES-D) scale
Depressive Symptoms
Measured: Change from baseline to 2-year follow-up
Interleukin-6
Inflammation (IL-6)
Measured: Change from baseline to 2-year follow-up
Secondary outcomes (8)
Baroreflex Sensitivity (BRS)
Arterial function (baroreceptors)
Measured: Change from baseline to 2-year follow-up
Arterial Compliance (AC)
Arterial function
Measured: Change from baseline to 2-year follow-up
Carotid Intima Media Thickness (IMT)
Vascular outcome
Measured: Change from baseline to 2-year follow-up
D-dimer
Coagulation
Measured: Change from baseline to 2-year follow-up
C-reactive Protein (CRP)
Inflammation
Measured: Change from baseline to 2-year follow-up
Tumor Necrosis Factor (TNF)- alpha
Biomarker
Measured: Change from baseline to 2-year follow-up
Plasminogen Activator Inhibitor (PAI)-1
Coagulation
Measured: Change from baseline to 2-year follow-up
von Willebrand Factor (vWF)
Coagulation
Measured: Change from baseline to 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startSep 2014
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Brent Mausbach, University of California, San Diego
- Investigators
- Brent T Mausbach, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317523
- Sponsor's protocol ID
- BMausbach
- Other IDs
- RF1AG015301
- Status last verified
- Sep 2019
- First submitted
- 11 Dec 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
von Kanel R, Mausbach BT, Dimsdale JE, Ziegler MG, Mills PJ, Allison MA, Patterson TL, Ancoli-Israel S, Grant I. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019 Jan 22;19(1):18. doi: 10.1186/s12877-019-1033-2.
PubMed 30669980
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Caregiver Coping: Mental and Physical Health
- ClinicalTrials.gov ID
- NCT02317523
- Acronym / sponsor ID
- BMausbach
- Conditions
- Alzheimer Disease, Alzheimer Dementia, Alzheimer's Disease, Dementia
- Keywords
- Dementia, Caregiver, Cardiovascular Disease, Stress, Depression, Anxiety, Heart Disease, Carer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2014
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Dec 2014 (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.
This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.
Detailed description
The burden of caring for a loved-one with Alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. These consequences including risk for depression, cardiovascular disease, and earlier mortality. Because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease.
The investigators aims are to determine whether a 6-week Behavioral Activation (BA) intervention, followed by 3 booster sessions over a period of 6 months, compared to an Information-Support (IS) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationBehavioral Activation (BA) emphasize self-monitoring as an aid for increasing one's engagement in self-reinforcing activities while simultaneously reducing negative avoidant coping responses. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each. |
| Information and Support | Active comparator | Behavioral: Information and SupportInformation and Support (IS) consists of providing education on Alzheimer's disease, coping with specific stresses prevalent in caregiving, and community-based services available for caregivers. Caregivers choose information most relevant to their current circumstances, and can discuss this with their counselor during the sessions. In addition, the IS condition encompasses elements of supportive therapy including empathy and active listening. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 55 years or older.
- Providing in-home care to a spouse with dementia.
Key exclusion criteria (9 listed)
- Taking Coumarin anticoagulants.
- Taking nitrates or niacin.
- Taking non-selective β-blockers.
- Glucocorticoid use in the 2 weeks prior to enrollment.
- Taking Aldomet or labetalol.
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 |
|---|---|---|
| Behavioral ActivationSix face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy | Behavioural | Behavioral Activation |
| Information and SupportSix face-to-face sessions (60 minutes each) of Supportive Therapy | Behavioural | Information and Support |
Primary outcome
Endothelium-dependent Flow Mediated Dilation (FMD)
Time frame: Change from baseline to 2-year follow-up
Flow-Mediated Dilation
Center for Epidemiologic Studies - Depression (CES-D) scale
Time frame: Change from baseline to 2-year follow-up
Depressive Symptoms
Interleukin-6
Time frame: Change from baseline to 2-year follow-up
Inflammation (IL-6)
8 secondary outcomes
Baroreflex Sensitivity (BRS)
Time frame: Change from baseline to 2-year follow-up
Arterial Compliance (AC)
Time frame: Change from baseline to 2-year follow-up
Carotid Intima Media Thickness (IMT)
Time frame: Change from baseline to 2-year follow-up
D-dimer
Time frame: Change from baseline to 2-year follow-up
C-reactive Protein (CRP)
Time frame: Change from baseline to 2-year follow-up
Tumor Necrosis Factor (TNF)- alpha
Time frame: Change from baseline to 2-year follow-up
Plasminogen Activator Inhibitor (PAI)-1
Time frame: Change from baseline to 2-year follow-up
von Willebrand Factor (vWF)
Time frame: Change from baseline to 2-year follow-up
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 26 Sep 2019.
- Derived from this study: PubMed 30669980von Kanel R, Mausbach BT, Dimsdale JE, Ziegler MG, Mills PJ, Allison MA, Patterson TL, Ancoli-Israel S, Grant I. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019 Jan 22;19(1):18. doi: 10.1186/s12877-019-1033-2.
- Individual participant dataSharing planned: Undecided
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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.
Brent T Mausbach, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Information and Support in people with Alzheimer Disease and Alzheimer Dementia, run by University of California, San Diego 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 2 inclusion and 9 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 26 Sep 2019. 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.
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?
Endothelium-dependent Flow Mediated Dilation (FMD) (time frame: Change from baseline to 2-year follow-up). The study lists 3 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 NCT02317523, 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 26 Sep 2019.