Family Telemental Health Intervention for Veterans With Dementia

NCT ID: NCT03116464

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2022-12-30

Brief 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). 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

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

Conditions

Dementia Family Caregiver Burden and Conflict

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Caregiver and patient with dementia dyads who receive the family intervention.

Group Type: EXPERIMENTAL

Telemental Health Family Intervention

Intervention Type: BEHAVIORAL

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

Interventions

Telemental Health Family Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cory K. Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Locations

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I21HX002256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PPO 16-131

Identifier Type: -

Identifier Source: org_study_id