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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • Benjamin Rose Institute

    Cleveland, Ohio, 44120

Other trials in United States

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 groups in NCT00632684
Study groupRoleWhat they receive
1Active comparatorParticipants in Phase 1 will undergo four interviews, including a single treatment planning session.
Receives: Behavioral: Interviews with a single treatment planning session
2ExperimentalParticipants 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.

  1. Role overload

    Measured: Measured immediately after treatment

Secondary outcomes (1)
  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.

  1. First posted11 Mar 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

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)
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

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.

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