A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia

Depressive Symptoms Clinical Trial

Official title:

A Ten-Week Online Acceptance and Commitment Therapy Intervention Guided by a Coach for Family Caregivers of People With Dementia: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043441
• Other study ID #: AARG-21-846868
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: Areum Han, PhD
• Phone: 205-975-2882
• Email: ahan[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Description:

This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. Caregivers randomly assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers randomly assigned to the control group will receive care as usual with psychoeducation materials provided during the study period. Outcomes regarding caregivers' mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 3-month follow-up) and compared between groups over time. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• community-dwelling adults (age 18 or over) who are currently taking the primary responsibility for the care of a relative with dementia living in the community
• having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
• having a computer or a smartphone with the internet access at home and
• being able to provide informed consent

Exclusion Criteria:

• having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
• having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
• taking antipsychotic or anticonvulsant medication at the time of recruitment
• considering or planning to place family members of PwD in a nursing home within 6 months or
• having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Acceptance and commitment therapy (ACT)
Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with psychoeducation materials provided.
• Psychoeducation
The psychoeducation control group will receive care as usual with psychoeducation materials provided.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to immediately after the intervention and 3 month follow-up on the Patient Health Questionnaire-9	The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Generalized Anxiety Disorder-7	The Generalized Anxiety Disorder-7 is a 7-item questionnaire assessing anxiety on a scale of 0 to 3. Scores range from 0 to 21. Higher scores indicate greater anxiety.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Perceived Stress Scale	The Perceived Stress Scale is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the World Health Organization Quality of Life - Psychological health component	World Health Organization Quality of Life - Psychological health component has 6 items measuring psychological quality of life on scale of 1 to 5. Scores range from 6 to 30. Higher scores denote higher quality of life in terms of psychological health.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Meuser Caregiver Grief Inventory	Marwit-Meuser Caregiver Grief Inventory Brief-Form is a 6-item self-report questionnaire assessing grief of caregivers on a scale of 1 to 5. Scores range from 6 to 30. Higher scores indicate higher levels of grief.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Caregiver Guilt Questionnaire	Caregiver Guilt Questionnaire is a 22-item self-report questionnaire assessing feelings of guilt in caregivers on a scale of 0 to 4. Scores range from 0 to 88. Higher scores indicate higher levels of guilt.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Self-Compassion Scale- Short Form	Self-Compassion Scale- Short Form is a 12-item self-report questionnaire assessing self-compassion on a scale of 1 to 5. Scores range from 12 to 60. Higher scores indicate higher levels of self-compassion.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Action and Acceptance Questionnaire-II	Action and Acceptance Questionnaire -II is a 7-item self-report questionnaire measuring psychological flexibility on a scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate poor psychological flexibility.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Cognitive Fusion Questionnaire	Cognitive Fusion Questionnaire -7 is a 7-item self-report questionnaire measuring cognitive fusion on scale of 1 to 7. Scores range from 7 to 49. Higher scores indicate greater levels of cognitive fusion.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3-month follow-up on the Engaged Living Scale	Engaged Living Scale -9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values and greater life fulfillment.	Change from baseline to immediately after the intervention and 3 month follow-up
Secondary	Change from baseline to immediately after the intervention and 3 month follow-up on the Zarit Burden Interview	Zarit Burden Interview is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. Higher scores indicate higher levels of burden. The total scores range from 0 to 48, and scores of 17 or greater indicate severe/high burden.	Change from baseline to immediately after the intervention and 3 month follow-up