Possible Therapy by Phone for Caregivers

NCT04634396 | Completed DMC

• 1 other identifier: 1904631305
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.

Conditions

Anxiety; Anxiety Disorders and Symptoms; Caregiver Burnout

Keywords

Alzheimer's disease; Dementia; Caregiving; Caregiver; Anxiety; Acceptance and commitment therapy; Telehealth

Outcome Measures

Primary Outcomes (1)

• Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)

  Anxiety will be measured using the GAD-7 which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10 and 15 are cut off scores for mild, moderate and severe anxiety respectively. An add-on item assessing the patient's global impression of symptom related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is sensitive to change

  through study completion, an average of 6 months

Secondary Outcomes (7)

• Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)

  through study completion, an average of 6 months

• Caregiver burden measured by the Zarit Burden Interview (ZBI)

  through study completion, an average of 6 months

• Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)

  through study completion, an average of 6 months

• Different strategies that caregivers use to cope measured with the Brief COPE

  through study completion, an average of 6 months

• Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)

  through study completion, an average of 6 months

Other Outcomes (2)

• The feasibility of the TACTICs Intervention will be measured by accrual rate, attendance of sessions, and the retention in the study

  baseline and through study completion, an average of 6 months.

• Caregivers acceptability of the TACTICs intervention

  through study completion, an average of 6 months

Study Arms (1)

Experimental TACTICs

OTHER

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of adults with dementia (TACICS. Participants will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1 hour sessions by a trained interventionalist

Behavioral: ACT Acceptance and Commitment Therapy

Interventions

ACT Acceptance and Commitment Therapy BEHAVIORAL

6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools

Experimental TACTICs

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Able to communicate in English
• Able to provide informed consent
• Listed as primary caregiver in the chart of a patient with Alzheimer's disease or related dementia (DARD)
• Intends to continue caregiving form ADRD patient for at least 12 months or greater
• Clinically elevated anxiety score (score of 10 or higher on GAD-7)

You may not qualify if:

• Non-family member of the ADRD patient
• Has ADRD or other serious mental illness diagnosis such as bipolar or schizophrenia as determined by ICD-10 code

Sponsors & Collaborators

• Indiana University: lead
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Regenstrief Institute, Inc.

Indianapolis, Indiana, 46202-4800, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Caregiver Burden; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Shelley A. Johns, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: single arm proof of concept study

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 18, 2020
• Study Start: June 14, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Spring, 2021
• Access Criteria: manuscripts

Locations

US (1)