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A Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention for Stroke Survivors

Primary Purpose

Depression, Anxiety, Stress

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acceptance and commitment therapy (ACT)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Acceptance and Commitment Therapy, Stroke, Mindfulness, Psychological health, Self-compassion, Depression, Anxiety, Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • community-dwelling adults (aged 18 or above) with a confirmed diagnosis of stroke
  • having at least mild symptoms of psychological distress measured by the Depression, Anxiety and Stress Scale
  • having a computer or a smartphone with internet access at home
  • being able to provide informed consent by understanding the nature of study participation

Exclusion Criteria:

  • living in a nursing home at time of consent
  • a diagnosis of severe cognitive impairment (e.g., dementia)
  • inability to understand spoken and/or written English
  • having severe communication difficulties (e.g., aphasia and dysarthria) that can impede study participation
  • having a life-threatening illness (e.g. advanced cancer or advanced heart failure) that would make survival for 6 months unlikely
  • having a diagnosis of other central nervous system disorders other than stroke or a severe mental illness (e.g., psychosis)
  • currently receiving a psychological therapy or participating in another study that may affect mental health
  • having a prior experience in ACT
  • having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
  • taking antipsychotic medication at the time of recruitment.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acceptance and commitment therapy (ACT) group

Control group

Arm Description

A total of 7 ACT sessions individually guided by a trained coach through Zoom videoconferencing

Care as usual

Outcomes

Primary Outcome Measures

Change from baseline to immediately after the intervention and 2-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 2-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 2-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.

Secondary Outcome Measures

Change from baseline to immediately after the intervention and 2-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 2-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 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) - Meaning and Purpose Short Form
The PROMIS Meaning and Purpose Short Form is a 4-item self-report questionnaire assessing meaning and purpose in life on a scale of 1 to 5. Scores range from 4 to 20. Higher scores indicate greater meaning and purpose in life.
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions - Short Form
The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Emotions - Short Form is a 4-item self-report questionnaire assessing an individual's self-efficacy for managing chronic conditions in terms of emotions on a scale of 1 to 5. The scores range from 4 to 20. Higher scores reflect greater self-efficacy in managing chronic conditions in terms of emotions.
Change from baseline to immediately after the intervention and 2-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 2-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 2-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.

Full Information

First Posted
October 18, 2021
Last Updated
February 11, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05097040
Brief Title
A Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention for Stroke Survivors
Official Title
Effects of a Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention on Stroke Survivors: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The research team decided not to implement this study.
Study Start Date
January 9, 2022 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed stroke survivors compared to the care-as-usual control group. A total of 24 stroke survivors who meet the inclusion criteria will be recruited and randomized to either the intervention group or the control group. Exploratory hypotheses are that the ACT group will show improvements in mental health outcomes (e.g., depressive symptoms, anxiety, and stress), and ACT processes (e.g., psychological flexibility/acceptance) at posttest and 2-month follow-up, compared to the care-as-usual control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of participants and explore participants' experiences in the ACT intervention through semi-structured interviews at posttest.
Detailed Description
This pilot randomized controlled trial aims to assess effects of a coach-guided individual online acceptance and commitment therapy (ACT) intervention on distressed stroke survivors compared to the care-as-usual control group. A total of 24 stroke survivors who meet the inclusion criteria will be recruited and randomized to either the intervention group or the control group. The intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 6 weeks through Zoom videoconferencing. Also, a one-time 1-hour booster session will be provided at 1-month follow-up to facilitate the maintenance of treatment effects. All ACT sessions will be delivered by our ACT coach, a licensed professional counselor (LPC) with substantial clinical experiences and expertise in ACT. Participants assigned to the control group will receive care as usual during the study period. Outcomes regarding mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 2-month follow-up) and compared between groups over time. Mental health outcomes and ACT processes will be measured using self-reported questionnaires. A 30-minute individual interview also will be conducted for participants in the intervention group through Zoom videoconferencing to explore participants' experiences in the ACT intervention. The participant demographic information form will be asked to complete at pretest only, asking participants' information such as age, gender, ethnicity/race, level of education, marital status, employment status, and time since stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Stress, Stroke
Keywords
Acceptance and Commitment Therapy, Stroke, Mindfulness, Psychological health, Self-compassion, Depression, Anxiety, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and commitment therapy (ACT) group
Arm Type
Experimental
Arm Description
A total of 7 ACT sessions individually guided by a trained coach through Zoom videoconferencing
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
acceptance and commitment therapy (ACT)
Intervention Description
The intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 6 weeks through Zoom videoconferencing. Also, a one-time 1-hour booster session will be provided at 1-month follow-up to facilitate the maintenance of treatment effects.
Primary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient Health Questionnaire-9
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Generalized Anxiety Disorder-7
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Perceived Stress Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the World Health Organization Quality of Life - Psychological health component
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Self-Compassion Scale- Short Form
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) - Meaning and Purpose Short Form
Description
The PROMIS Meaning and Purpose Short Form is a 4-item self-report questionnaire assessing meaning and purpose in life on a scale of 1 to 5. Scores range from 4 to 20. Higher scores indicate greater meaning and purpose in life.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Emotions - Short Form
Description
The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Emotions - Short Form is a 4-item self-report questionnaire assessing an individual's self-efficacy for managing chronic conditions in terms of emotions on a scale of 1 to 5. The scores range from 4 to 20. Higher scores reflect greater self-efficacy in managing chronic conditions in terms of emotions.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Action and Acceptance Questionnaire-II
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Cognitive Fusion Questionnaire
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Title
Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale
Description
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.
Time Frame
Change from baseline to immediately after the intervention and 2-month follow-up
Other Pre-specified Outcome Measures:
Title
Interviews of participants
Description
Participants' experiences in the ACT intervention will be explored using individual interviews at the immediate completion of 6 weekly ACT sessions. Each interview will last for about 30 minutes.
Time Frame
Immediately after completing 6 weekly ACT sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: community-dwelling adults (aged 18 or above) with a confirmed diagnosis of stroke having at least mild symptoms of psychological distress measured by the Depression, Anxiety and Stress Scale having a computer or a smartphone with internet access at home being able to provide informed consent by understanding the nature of study participation Exclusion Criteria: living in a nursing home at time of consent a diagnosis of severe cognitive impairment (e.g., dementia) inability to understand spoken and/or written English having severe communication difficulties (e.g., aphasia and dysarthria) that can impede study participation having a life-threatening illness (e.g. advanced cancer or advanced heart failure) that would make survival for 6 months unlikely having a diagnosis of other central nervous system disorders other than stroke or a severe mental illness (e.g., psychosis) currently receiving a psychological therapy or participating in another study that may affect mental health having a prior experience in ACT having psychiatric hospitalizations or diagnoses of mental illness in the previous two years taking antipsychotic medication at the time of recruitment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areum Han, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention for Stroke Survivors

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