AnxietyTACTICsNCT04634396
Possible Therapy by Phone for Caregivers
A study testing ACT Acceptance and Commitment Therapy in people with Anxiety and Anxiety Disorders and Symptoms, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout
- What is being tested?
- ACT Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2019to 9 Dec 2019
- 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 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)
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, 46202-4800
About this study
Official title: Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot
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.
Read the detailed description
Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. The Investigators are trying to determine proof of concept that suggests that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. This study will recruit N=20 dementia caregivers to receive 6 weekly 1-hour telephone-based ACT sessions
- Conditions
- Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout
- Being tested
- ACT Acceptance and Commitment Therapy
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth
- Medical subject headings
- Anxiety Disorders, Caregiver Burden, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Acceptance and Commitment TherapyBehavioural
6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: ACT Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 6 months
Secondary outcomes (7)
Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)
Depressive symptoms will be measured using the 9 item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0-27. 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: through study completion, an average of 6 months
Caregiver burden measured by the Zarit Burden Interview (ZBI)
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: through study completion, an average of 6 months
Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)
Well being will be measured using the (ESS). With prior testing in ADRD caregivers, the ESS contains 33 items across 3 subscales: physical (9items), 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: through study completion, an average of 6 months
Different strategies that caregivers use to cope measured with the Brief COPE
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: through study completion, an average of 6 months
Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)
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: through study completion, an average of 6 months
Overall quality of life will be measured with the NIH PROMIS Global Health measure
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: through study completion, an average of 6 months
Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)
Anticipatory grief will be measured by the AGS, a 27 item self report tool designed to assess the bereavement experience of dementia caregivers. Items are scored on a 5-point Likert type scale with responses ranging from "strongly disagree" to "strongly agree".
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start14 Jun 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm proof of concept study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Nicole R. Fowler, PhD, Indiana University
- Investigators
- Shelley A. Johns, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634396
- Sponsor's protocol ID
- 1904631305
- Acronym
- TACTICs
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2020
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. 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. A Single Arm Pilot
- ClinicalTrials.gov ID
- NCT04634396
- Acronym / sponsor ID
- TACTICs / 1904631305
- Conditions
- Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout
- Keywords
- Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Regenstrief Institute, Inc.
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 18 Nov 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 stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.
Detailed description
Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. The Investigators are trying to determine proof of concept that suggests that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. This study will recruit N=20 dementia caregivers to receive 6 weekly 1-hour telephone-based ACT sessions
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm proof of concept study
| Arm | Type | Receives |
|---|---|---|
| Experimental TACTICs | Other | Behavioral: ACT Acceptance and Commitment TherapyTelephone 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 related dementia (DARD)
- Intends to continue caregiving form ADRD patient for at least 12 months or greater
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 |
|---|---|---|
| ACT Acceptance and Commitment Therapy6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools | Behavioural | Experimental TACTICs |
Primary outcome
Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7)
Time frame: through study completion, an average of 6 months
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
7 secondary outcomes
Depressive symptoms measured by the Patient Health Questionnarie-9 (PHQ-9)
Time frame: through study completion, an average of 6 months
Caregiver burden measured by the Zarit Burden Interview (ZBI)
Time frame: through study completion, an average of 6 months
Physical, emotional and existential suffering to caregivers measured by the Experience of Suffering Scale (ESS)
Time frame: through study completion, an average of 6 months
Different strategies that caregivers use to cope measured with the Brief COPE
Time frame: through study completion, an average of 6 months
Caregivers psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: through study completion, an average of 6 months
Overall quality of life will be measured with the NIH PROMIS Global Health measure
Time frame: through study completion, an average of 6 months
Caregivers grief during active caregiving will be measured with the Anticipatory Grief Scale (AGS)
Time frame: through study completion, an average of 6 months
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 29 Mar 2023.
- 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, PhD 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 ACT Acceptance and Commitment Therapy in people with Anxiety and Anxiety Disorders and Symptoms, 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 6 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 29 Mar 2023. 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?
Anxiety symptoms measured by the Generalized Anxiety Disorder Scale (GAD-7) (time frame: through study completion, an average of 6 months). 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 29 Mar 2023.