Possible Therapy by Phone for Caregivers

Study Overview
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Brief Summary
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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
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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

Official Title
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Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With Alzheimer's Disease and Related Dementias. A Single Arm Pilot

Conditions
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Anxiety, Anxiety Disorders and Symptoms, Caregiver Burnout

Intervention / Treatment
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* Behavioral: ACT Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: single arm proof of concept study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental TACTICs<br>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<br>* 6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Dementia, Caregiving, Caregiver, Anxiety, Acceptance and commitment therapy, Telehealth