StressNCT00632684
Effectiveness of an Adaptive Treatment Model for At-risk Family Caregivers
A study testing Interviews with a single treatment planning session and Adaptive treatment model in people with Stress, run by Penn State University at 1 site in United States.
Trial summary
This study will develop and evaluate the effectiveness of an adaptive treatment model for reducing the stress of, and burden on, family members caring for a person with dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Interviews with a single treatment planning session and Adaptive treatment model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caregiver of a person suffering from any type of dementia and living in the community
Who cannot join
- Primary caregiver of person with late- or end-of-life stage dementia
- Primary caregiver of person with dementia who lives in skilled nursing care environment
- Primary caregiver is under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Intervention for At-risk Family Caregivers
This study will develop and evaluate the effectiveness of an adaptive treatment model for reducing the stress of, and burden on, family members caring for a person with dementia.
Read the detailed description
Caring for a person with dementia can be a highly stressful experience associated with a variety of negative outcomes. Family caregivers are more likely than noncaregivers to experience symptoms of depression and anxiety, feelings of anger, and health problems. Although there are multiple treatment models to address the adverse mental and physical health outcomes associated with caregiving, most do not account for the specific risk and protective factor differences among caregivers of people with dementia. Such models provide the same treatment to all participants and have demonstrated only limited success in this high-risk caregiver population. An adaptive treatment model based on the Stress Process Model of caregiving, which emphasizes that there are multiple factors that affect stress, social support, and mental health, may better meet the needs of family caregivers. This study will first develop an adaptive treatment model, based on the Stress Process Model, for family caregivers of a person suffering from dementia. The study will then evaluate the effectiveness of each component of the adaptive treatment model in improving negative outcomes in the family caregivers.
This study will be conducted in two phases. Phase 1 will be used to develop an adaptive treatment model and risk report from which tailored treatment will be prescribed to participants in Phase 2. Participants in Phase 1 will attend four 90-minute interviews over 4 months. The first three interviews will be held in the first 3 to 4 weeks of the study and the last will be about 3 months later. In the first interview, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. In the second and third interviews, participants will discuss their caregiving situations in more detail and will receive information about programs and services that may help them carry out caregiving activities. During the final interview, participants will again be asked about their experiences caring for their relatives.
Phase 2 of the study will test the adaptive treatment model developed in Phase 1. Participants in Phase 2 will attend an initial and final interview and up to 10 planning sessions. Each interview or planning session will last 60 to 75 minutes and will be tailored to the risks of each individual caregiver. During planning sessions, participants will discuss their caregiving situations in more detail, learn strategies to deal with stress, and receive information about programs and services that may help in carrying out caregiving activities. The strategies that participants will learn may include the following: new skills for communicating with the person receiving care, reflecting upon ways to reduce the impact of the changes that caregiving has had on their lives, learning more effective ways of communicating their own needs to other family members and friends, and identifying which types of services might be useful in caring for the person with dementia. The Phase 2 interviews will be the same as the initial and final interviews of Phase 1.
- Conditions
- Stress
- Being tested
- Interviews with a single treatment planning session, Adaptive treatment model
- Keywords
- Family Caregiving, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews with a single treatment planning sessionBehavioural
Participants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities.
Adaptive treatment modelBehavioural
The adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants in Phase 1 will undergo four interviews, including a single treatment planning session. Receives: Behavioral: Interviews with a single treatment planning session |
| 2 | Experimental | Participants in Phase 2 will receive the adaptive treatment model. Receives: Behavioral: Adaptive treatment model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role overload
Measured: Measured immediately after treatment
Secondary outcomes (1)
Nine-Item Depression Scale of the Patient Health Questionnaire (PHQ-9)
Measured: Measured immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Steven H. Zarit, PhD, Principal investigator, Penn State UniversityCarol J. Whitlatch, PhD, Principal investigator, Benjamin Rose Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632684
- Sponsor's protocol ID
- R34MH073559
- Other IDs
- R34MH073559, DATR A4-GPS
- Status last verified
- Apr 2009
- First submitted
- 7 Mar 2008
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Intervention for At-risk Family Caregivers
- ClinicalTrials.gov ID
- NCT00632684
- Acronym / sponsor ID
- R34MH073559
- Conditions
- Stress
- Keywords
- Family Caregiving, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Mar 2008 (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 will develop and evaluate the effectiveness of an adaptive treatment model for reducing the stress of, and burden on, family members caring for a person with dementia.
Detailed description
Caring for a person with dementia can be a highly stressful experience associated with a variety of negative outcomes. Family caregivers are more likely than noncaregivers to experience symptoms of depression and anxiety, feelings of anger, and health problems. Although there are multiple treatment models to address the adverse mental and physical health outcomes associated with caregiving, most do not account for the specific risk and protective factor differences among caregivers of people with dementia. Such models provide the same treatment to all participants and have demonstrated only limited success in this high-risk caregiver population. An adaptive treatment model based on the Stress Process Model of caregiving, which emphasizes that there are multiple factors that affect stress, social support, and mental health, may better meet the needs of family caregivers. This study will first develop an adaptive treatment model, based on the Stress Process Model, for family caregivers of a person suffering from dementia. The study will then evaluate the effectiveness of each component of the adaptive treatment model in improving negative outcomes in the family caregivers.
This study will be conducted in two phases. Phase 1 will be used to develop an adaptive treatment model and risk report from which tailored treatment will be prescribed to participants in Phase 2. Participants in Phase 1 will attend four 90-minute interviews over 4 months. The first three interviews will be held in the first 3 to 4 weeks of the study and the last will be about 3 months later. In the first interview, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. In the second and third interviews, participants will discuss their caregiving situations in more detail and will receive information about programs and services that may help them carry out caregiving activities. During the final interview, participants will again be asked about their experiences caring for their relatives.
Phase 2 of the study will test the adaptive treatment model developed in Phase 1. Participants in Phase 2 will attend an initial and final interview and up to 10 planning sessions. Each interview or planning session will last 60 to 75 minutes and will be tailored to the risks of each individual caregiver. During planning sessions, participants will discuss their caregiving situations in more detail, learn strategies to deal with stress, and receive information about programs and services that may help in carrying out caregiving activities. The strategies that participants will learn may include the following: new skills for communicating with the person receiving care, reflecting upon ways to reduce the impact of the changes that caregiving has had on their lives, learning more effective ways of communicating their own needs to other family members and friends, and identifying which types of services might be useful in caring for the person with dementia. The Phase 2 interviews will be the same as the initial and final interviews of Phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Interviews with a single treatment planning sessionParticipants in Phase 1 will undergo four interviews, including a single treatment planning session. |
| 2 | Experimental | Behavioral: Adaptive treatment modelParticipants in Phase 2 will receive the adaptive treatment model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary caregiver of a person suffering from any type of dementia and living in the community
Key exclusion criteria (3 listed)
- Primary caregiver of person with late- or end-of-life stage dementia
- Primary caregiver of person with dementia who lives in skilled nursing care environment
- Primary caregiver is under the age of 18
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 |
|---|---|---|
| Interviews with a single treatment planning sessionParticipants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities. | Behavioural | 1 |
| Adaptive treatment modelThe adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors. | Behavioural | 2 |
Primary outcome
Role overload
Time frame: Measured immediately after treatment
1 secondary outcome
Nine-Item Depression Scale of the Patient Health Questionnaire (PHQ-9)
Time frame: Measured immediately after treatment
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 23 Nov 2011.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Steven H. Zarit, PhD principal investigator
Penn State University
Carol J. Whitlatch, PhD principal investigator
Benjamin Rose Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interviews with a single treatment planning session and Adaptive treatment model in people with Stress, run by Penn State University 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 3 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 23 Nov 2011. 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?
Role overload (time frame: Measured immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2011.