AnxietyTACTICsNCT04338750
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Dementia
A study testing Telephone Acceptance and Commitment Therapy Intervention for Caregivers in people with Anxiety and Anxiety Generalized, run by Indiana University at 1 site in United States.
Trial summary
Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anxiety, Anxiety Generalized, Anxiety Disorders and Symptoms
- What is being tested?
- Telephone Acceptance and Commitment Therapy Intervention for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 9 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 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 a related dementia (ADRD)
- Self-identifies as ADRD patient's primary caregiver
- Intends to continue caregiving for ADRD patient for ≥12 months
- Clinically-elevated anxiety (score of 10 or higher on GAD-7)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regenstrief Institute, Inc.
Indianapolis, Indiana, 46202
About this study
Official title: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial
Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.
Read the detailed description
The objective of this pilot randomized controlled trial is to assess feasibility, acceptability, and preliminary effects of Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) of adults with Alzheimer's disease or related dementias. Using a 2-arm randomized design, we will examine the effects of TACTICs compared to a minimally enhanced usual care group (mEUC) in N=60 dementia caregivers. Primary dementia caregivers with clinically-significant anxiety will be randomized in equal numbers to receive either TACTICs or mEUC. The specific aims are to: (1) Evaluate the feasibility and acceptability of TACTICs. Feasibility will be assessed using caregiver accrual, retention, and TACTICs session attendance rates. Acceptability will be assessed using a participant-reported satisfaction item administered upon intervention completion. (2) Measure the changes in caregiver anxiety and depressive symptoms, caregiver burden, wellbeing, and psychological flexibility at post-intervention (T2) and 3 months (T3) and 6 months (T4) post-intervention compared to baseline. Caregivers will be recruited from a variety of sources, including the Indiana Alzheimer's Disease Center (IADC), Aging Brain Care program at Eskenazi Health, and Indiana University Health geriatric psychiatry and neurology practices. Study staff will contact potentially-eligible caregivers to assess interest and verify eligibility. After providing informed consent and enrolling in the trial, interested and eligible caregivers will complete baseline measures and be randomly assigned in equal numbers to either the TACTICs intervention (n=30) or to mEUC (n=30) using a block randomization scheme. Randomization will be performed in REDCap using a SAS procedure. All study personnel will be blind to allocation sequence. The unblinded research coordinator will be responsible for randomizing participants in REDCap. The PI, Co-Investigators, and research assistants (i.e., recruiters and outcome assessors) will be blind to intervention assignment to reduce the risk of outcome expectancy bias and to enhance the rigor of the trial.
- Being tested
- Telephone Acceptance and Commitment Therapy Intervention for Caregivers, minimally-Enhanced Usual Care
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Caregiver Burden, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Acceptance and Commitment Therapy Intervention for CaregiversBehavioural
Also called TACTICs
Participants randomized to TACTICs will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1-hour sessions by a trained Bachelor's-level interventionist. Participants in this intervention will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' caregiving experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to anxiety and caregiving challenges. Participants will receive handouts on session topics and a CD with guided mindfulness practices.
minimally-Enhanced Usual CareBehavioural
Also called mEUC
Participants randomized to mEUC will receive a letter thanking them for participating in the trial along with the Alzheimer's Caregiving guide from the National Institute of Aging of the National Institutes of Health (https://www.nia.nih.gov/health/alzheimers/caregiving), coupled with a listing of the five Alzheimer's Association sponsored support groups closest to their home address.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) | Experimental | Participants in the ACT arm will learn new and more adaptive ways to respond to challenges, including anxiety and the irreversibility of dementia and its behavioral manifestations. Receives: Behavioral: Telephone Acceptance and Commitment Therapy Intervention for Caregivers |
| minimally-Enhanced Usual Care (mEUC) | Active comparator | Participants randomized to mEUC will receive educational, science-based reading and resources, including a listing of Alzheimer's Association sponsored support groups closest to their home address. Receives: Behavioral: minimally-Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)
Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which 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.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Secondary outcomes (7)
Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)
Changes in depressive symptoms will be measured using the 9-item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0 to 27, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 has factorial validity for the diagnosis of major depressive disorder.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)
Changes in caregiver burden will be measured using the Zarit Burden Interview (ZBI). This two-factor, 22-item scale 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.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)
Changes in wellbeing will be measured using the Experience of Suffering Scale (ESS). With prior testing in ADRD caregivers, the ESS 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.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Coping via Brief COPE
Changes in coping will be measured with the 28-item Brief COPE, a measure of coping strategies used in response to stressors. Comprised of 28 coping strategies, the Brief COPE contains 14 two-item subscales, each analyzed separately: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, venting, behavioral disengagement, positive reframing, planning, humor, acceptance, religion, and self-blame.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)
Changes in psychological flexibility and its opposite, experiential avoidance, will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Respondents rate how true each statement (e.g., "It is okay if I remember something unpleasant") is for them on a 7-point Likert-type scale anchored from 1=never true to 7=always true. Higher scores indicate greater psychological flexibility or acceptance.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Quality of Life via PROMIS Global Health measure
Changes in quality of life will be assessed with the 10-item PROMIS Global Health measure. On a 5-point scale, participants rate their mental and physical well-being with higher scores indicative of better health.
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS)
Changes in anticipatory grief will be measured with the Anticipatory Grief Scale (AGS), a 27-item self-report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert scale with responses ranging from "strongly disagree" to "strongly agree."
Measured: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start24 Mar 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregivers of adults with Alzheimer's disease or related dementias (N = 60) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy delivered by telephone (TACTICs) or minimally-enhanced usual care (mEUC) using a block randomization scheme.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Shelley Johns, Indiana University
- Investigators
- Shelley A. Johns, PsyD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338750
- Sponsor's protocol ID
- 2002468698
- Acronym
- TACTICs
- Status last verified
- Jul 2022
- First submitted
- 2 Apr 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In future manuscripts, the authors will list contact information and state that IPD is available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias (TACTICs): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04338750
- Acronym / sponsor ID
- TACTICs / 2002468698
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, Regenstrief Institute, Inc.
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caregivers of adults with dementia report higher distress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases. Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. Results from our recent proof-of-concept study suggest that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. In this study, we will randomize N=60 dementia caregivers in equal numbers to receive either 6 weekly 1-hour telephone-based ACT sessions (TACTICs; experimental) or minimally-enhanced usual care (mEUC; control). We hypothesize that our TACTICs intervention will be feasible and acceptable in this population and will have a greater impact on reducing anxiety and secondary outcomes from baseline to post-intervention, and 3 and 6 months later.
Detailed description
The objective of this pilot randomized controlled trial is to assess feasibility, acceptability, and preliminary effects of Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) of adults with Alzheimer's disease or related dementias. Using a 2-arm randomized design, we will examine the effects of TACTICs compared to a minimally enhanced usual care group (mEUC) in N=60 dementia caregivers. Primary dementia caregivers with clinically-significant anxiety will be randomized in equal numbers to receive either TACTICs or mEUC. The specific aims are to: (1) Evaluate the feasibility and acceptability of TACTICs. Feasibility will be assessed using caregiver accrual, retention, and TACTICs session attendance rates. Acceptability will be assessed using a participant-reported satisfaction item administered upon intervention completion. (2) Measure the changes in caregiver anxiety and depressive symptoms, caregiver burden, wellbeing, and psychological flexibility at post-intervention (T2) and 3 months (T3) and 6 months (T4) post-intervention compared to baseline. Caregivers will be recruited from a variety of sources, including the Indiana Alzheimer's Disease Center (IADC), Aging Brain Care program at Eskenazi Health, and Indiana University Health geriatric psychiatry and neurology practices. Study staff will contact potentially-eligible caregivers to assess interest and verify eligibility. After providing informed consent and enrolling in the trial, interested and eligible caregivers will complete baseline measures and be randomly assigned in equal numbers to either the TACTICs intervention (n=30) or to mEUC (n=30) using a block randomization scheme. Randomization will be performed in REDCap using a SAS procedure. All study personnel will be blind to allocation sequence. The unblinded research coordinator will be responsible for randomizing participants in REDCap. The PI, Co-Investigators, and research assistants (i.e., recruiters and outcome assessors) will be blind to intervention assignment to reduce the risk of outcome expectancy bias and to enhance the rigor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Caregivers of adults with Alzheimer's disease or related dementias (N = 60) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy delivered by telephone (TACTICs) or minimally-enhanced usual care (mEUC) using a block randomization scheme.
| Arm | Type | Receives |
|---|---|---|
| Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) | Experimental | Behavioral: Telephone Acceptance and Commitment Therapy Intervention for CaregiversParticipants in the ACT arm will learn new and more adaptive ways to respond to challenges, including anxiety and the irreversibility of dementia and its behavioral manifestations. |
| minimally-Enhanced Usual Care (mEUC) | Active comparator | Behavioral: minimally-Enhanced Usual CareParticipants randomized to mEUC will receive educational, science-based reading and resources, including a listing of Alzheimer's Association sponsored support groups closest to their home address. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21 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 a related dementia (ADRD)
- Self-identifies as ADRD patient's primary caregiver
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Acceptance and Commitment Therapy Intervention for CaregiversAlso: TACTICsParticipants randomized to TACTICs will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1-hour sessions by a trained Bachelor's-level interventionist. Participants in this intervention will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' caregiving experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to anxiety and caregiving challenges. Participants will receive handouts on session topics and a CD with guided mindfulness practices. | Behavioural | Telephone Acceptance and Commitment Therapy Intervention for Caregivers (TACTICs) |
| minimally-Enhanced Usual CareAlso: mEUCParticipants randomized to mEUC will receive a letter thanking them for participating in the trial along with the Alzheimer's Caregiving guide from the National Institute of Aging of the National Institutes of Health (https://www.nia.nih.gov/health/alzheimers/caregiving), coupled with a listing of the five Alzheimer's Association sponsored support groups closest to their home address. | Behavioural | minimally-Enhanced Usual Care (mEUC) |
Primary outcome
Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which 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.
7 secondary outcomes
Change in Baseline Depressive Symptoms via Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Caregiver Burden via Zarit Burden Interview (ZBI)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Wellbeing via Experience of Suffering Scale (ESS)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Coping via Brief COPE
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Psychological Flexibility via Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Quality of Life via PROMIS Global Health measure
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Change in Baseline Anticipatory Grief via Anticipatory Grief Scale (AGS)
Time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: Yes. In future manuscripts, the authors will list contact information and state that IPD is available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley A. Johns, PsyD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Acceptance and Commitment Therapy Intervention for Caregivers in people with Anxiety and Anxiety Generalized, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline Anxiety via Generalized Anxiety Disorder scale-7 (GAD-7) (time frame: baseline, post-intervention (7-9 weeks post-baseline), 3 months post-intervention, 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.