TMH Pilot: Family Telemental Health Intervention for Veterans With Dementia

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT03116464
Collaborator
(none)
20
1
1
75.4
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telemental Health Family Intervention
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Family Telemental Health Intervention for Veterans With Dementia
Actual Study Start Date :
Sep 18, 2017
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

Behavioral: 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

Outcome Measures

Primary Outcome Measures

  1. Healthy Aging Brain Center Monitor (HABC Monitor): [Post Treatment, an average of 12-18 weeks]

    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.

Secondary Outcome Measures

  1. The Kansas Marital Conflict Scale (KMCS) [Post Treatment, an average of 12-18 weeks]

    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.

  2. Patient Health Questionnaire - 9 (PHQ) [Post Treatment, an average of 12-18 weeks]

    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).

  3. Zarit Burden Scale [Post Treatment, an average of 12-18 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY New York New York United States 10010

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Cory K. Chen, PhD, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03116464
Other Study ID Numbers:
  • PPO 16-131
  • I21HX002256
First Posted:
Apr 17, 2017
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022