Skip to main content
OpenTrials
Completed

NCT Number: NCT04780178

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD

The purpose of the study is to test if Acceptance and Commitment Therapy (ACT), a behavioral intervention designed to increase psychological flexibility in the face of challenges, reduces anxiety associated psychological distress in dementia caregivers compared to the control group who will receive self-help and educational materials. This version of ACT is delivered over the phone in six primary sessions and one booster session.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUH

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Listed in ADRD patient's chart as primary caregiver or self-identifies as ADRD patient's primary caregiver
  • Intends to continue caregiving for ≥12 months
  • Clinically-significant anxiety (score ≥10 on GAD-7)
  • 21 years or older
  • Able to communicate in English
  • Able to provide informed consent

Exclusion criteria

  • Caregiver is a non-family member
  • Care recipient is in an assisted living or nursing home (at baseline)
  • Has ADRD or other serious mental illness diagnosis such as schizophrenia as determined by ICD-10 code or self-report
  • Caregiver is enrolled in an existing ADRD collaborative program at Eskenazi Health, IU Health or the VA.
  • Caregiver is enrolled in another IU study that is testing a ADRD caregiver intervention

Treatment and study plan

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias

Behavioral

A telephone-based acceptance and commitment therapy for caregivers

Other names: TACTICs

Primary outcomes

  1. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    The Generalized Anxiety Disorder Scale (GAD-7) contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs 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.

Other outcomes

  1. Patient Health Questionnaire-8

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    8-item Patient Health Questionnaire-8 assesses depressive symptoms. With total scores ranging from 0 to 24, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-8 has factorial validity for the diagnosis of major depressive disorder.

  2. Zarit Burden Interview

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    The Zarit Burden Interview is a two-factor, 22-item scale that measures personal strain and role strain in caregiving by summing responses to a total score (0-20 little or no burden; 21-40 mild to moderate burden; 41-60 moderate to severe burden; and 61-88 severe burden). The ZBI measures change over time resulting from the progression of the patient's symptoms or from interventions aimed at reducing burden.

  3. Experience of Suffering Scale

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    The Experience of Suffering Scale contains 33 items across 3 subscales: physical (9 items), psychological (15 items), and existential (9 items) suffering. Total scores for each subscale are calculated with higher scores indicating more suffering within each domain.

  4. Multidimensional Psychological Flexibility Inventory

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    The 24-item Multidimensional Psychological Flexibility Inventory - Short form measures psychological flexibility and inflexibility. Respondents rate how true each statement is for them on a 6-point Likert-type scale anchored from 1=never true to 6=always true. Higher scores indicate higher levels of the dimension being assessed (i.e., psychological flexibility, psychological inflexibility).

  5. Satisfaction with Life Scale

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    The 5-item Satisfaction with Life Scale measures wellbeing. On a 7-point scale, participants indicate how much they agree or disagree with each of the 5 items to assess cognitive judgments of life satisfaction.

  6. Quality of Life in Alzheimer's Disease

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    Quality of Life in Alzheimer's Disease measures caregiver reported measure about the patient's quality of life and will provide preliminary data on the potential impact of the intervention on the person with ADRD for whom enrolled caregiver is caring for.

  7. Intervention Acceptability

    Time frame: Post-intervention (7-9 weeks post-baseline)

    Intervention acceptability is measured at T2 using an investigator-created 5-item measure of quantitative and qualitative satisfaction items.

  8. Health Care and Resource Utilization

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month

    Health care and resource utilization will be measured using an investigator-created 8-item measure. Items will assess caregiver-reported health and mental care utilization (e.g., emergency department [ED], inpatient, outpatient) and services accessed or used to support their caregiving (e.g., support groups, respite care, in-home aid).

  9. Inventory of Complicated Grief

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month ICG will (only) be measured in participants who have their loved one with dementia die during the study and agree to this survey

    The 19-item Inventory of Complicated Grief measures post death grief and bereavement in participants who have lost their loved one with dementia during the study. Each item is rated on a 5-point Likert scale with responses ranging from "never" to "always".

  10. Anticipatory grief

    Time frame: Baseline, post-intervention (7-9 weeks post-baseline), 3-month, 6-month AGS will (only) be measured in participants who have their loved one with dementia die during the study and agree to this survey

    the Anticipatory Grief Scale (AGS),43 a 27-item self-report tool designed to assess anticipatory grief of dementia caregivers. Items are scored on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree."

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Cleveland State University

Registry information

Official study title

Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial (RRF)

Acronym: (TACTICs)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.