Dementia Family Caregiver Burden and ConflictTMH PilotNCT03116464
Family Telemental Health Intervention for Veterans With Dementia
A study testing Telemental Health Family Intervention in people with Dementia Family Caregiver Burden and Conflict, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Family Caregiver Burden and Conflict
- What is being tested?
- Telemental Health Family Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 30 Dec 2022
- Phase
- Interventional
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
- Either the caregiver or the care-recipient must be a Veteran.
- The caregiver must:
- Be the primary unpaid family or friend who helps or supports an individual with dementia
- Be involved in the care of the person with dementia (at least 4 hours of care per day)
- Report that the care-recipient exhibits behavioral problems that are distressing
- Not be currently receiving the REACH VA protocol
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- Additionally, the care-recipient must:
- Must have a documented diagnosis of dementia
- Have cognitive impairment (MMSE<23 or SLUMS<20 or diagnosis of dementia based on chart review)
- Be out of bed and able to respond to a caregiver's instructions or interventions
Who cannot join
- Caregiver severe cognitive impairment
- Caregiver inability to meet study demands
- Caregiver psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
About this study
Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.
Read the detailed description
Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.
- Being tested
- Telemental Health Family Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemental Health Family InterventionBehavioural
Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Caregiver and patient with dementia dyads who receive the family intervention. Receives: Behavioral: Telemental Health Family Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Aging Brain Center Monitor (HABC Monitor):
A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity.
Measured: Post Treatment, an average of 12-18 weeks
Secondary outcomes (3)
The Kansas Marital Conflict Scale (KMCS)
A 37-item self-report scale consisting of three subscales of how well partners are able to: (1) listen and understand each other's perspectives, (2) express his or her point of view , and (3) come to a mutually satisfactory compromise. It has been shown to have high internal consistency ( = .87 to .90) and test-retest reliability (r = .62 to .92). Although developed for marital relationships, all items are applicable or easily modified for a variety of interpersonal relationships.
Measured: Post Treatment, an average of 12-18 weeks
Patient Health Questionnaire - 9 (PHQ)
A 9-item self-report scale based on DSM-IV criteria for Major Depressive Disorder, has been shown to have good sensitivity and specificity and is predictive of health outcomes such as sick days, clinic visits, and symptom related difficulty. Internal reliability of the PHQ-9 is excellent ( = 0.89).
Measured: Post Treatment, an average of 12-18 weeks
Zarit Burden Scale
A 12-item self-report scale shown to have acceptable indices of internal consistency for the two distinct factors of the scale - personal strain and role strain ( =0.88 and =0.78) and a good predictor of caregiver mental health outcomes.
Measured: Post Treatment, an average of 12-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start18 Sep 2017
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Why it stopped: Insufficient recruitment and resources to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia Family Caregiver Burden and ConflictStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Family based telemental health intervention that incorporates: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) "meaning making" (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cory K. Chen, PhD, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116464
- Sponsor's protocol ID
- PPO 16-131
- Other IDs
- I21HX002256
- Acronym
- TMH Pilot
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2017
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No