Family Telemental Health Intervention for Veterans With Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.

Official Title
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Family Telemental Health Intervention for Veterans With Dementia

Conditions
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Dementia Family Caregiver Burden and Conflict

Intervention / Treatment
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* Behavioral: Telemental Health Family Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: Caregiver severe cognitive impairment Caregiver inability to meet study demands Caregiver psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Caregiver and patient with dementia dyads who receive the family intervention. | Behavioral: Telemental Health Family Intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post Treatment, an average of 12-18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | Post Treatment, an average of 12-18 weeks |