DepressionNCT05097040
A Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention for Stroke Survivors
A study testing acceptance and commitment therapy (ACT) in people with Depression and Anxiety, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2022to 11 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Effects of a Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention on Stroke Survivors: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depression, Anxiety, Stress, Stroke
- Being tested
- acceptance and commitment therapy (ACT)
- Keywords
- Acceptance and Commitment Therapy, Stroke, Mindfulness, Psychological health, Self-compassion, Depression, Anxiety, Stress
- Medical subject headings
- Depression, Anxiety Disorders, Stroke, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acceptance and commitment therapy (ACT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | A total of 7 ACT sessions individually guided by a trained coach through Zoom videoconferencing Receives: Behavioral: acceptance and commitment therapy (ACT) |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
Secondary outcomes (7)
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
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.
Measured: Change from baseline to immediately after the intervention and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start9 Jan 2022
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: The research team decided not to implement this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areum Han, University of Alabama at Birmingham
- Investigators
- Areum Han, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097040
- Sponsor's protocol ID
- IRB-300008160
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Coach-Guided Online Acceptance and Commitment Therapy (ACT) Intervention on Stroke Survivors: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05097040
- Acronym / sponsor ID
- IRB-300008160
- Conditions
- Depression, Anxiety, Stress, Stroke
- Keywords
- Acceptance and Commitment Therapy, Stroke, Mindfulness, Psychological health, Self-compassion, Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research team decided not to implement this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 27 Oct 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | Behavioral: acceptance and commitment therapy (ACT)A total of 7 ACT sessions individually guided by a trained coach through Zoom videoconferencing |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| acceptance and commitment therapy (ACT)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. | Behavioural | Acceptance and commitment therapy (ACT) group |
Primary outcome
Change from baseline to immediately after the intervention and 2-month follow-up on the Patient Health Questionnaire-9
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
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
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
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
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
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.
7 secondary outcomes
Change from baseline to immediately after the intervention and 2-month follow-up on the World Health Organization Quality of Life - Psychological health component
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
Change from baseline to immediately after the intervention and 2-month follow-up on the Self-Compassion Scale- Short Form
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
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
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
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
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
Change from baseline to immediately after the intervention and 2-month follow-up on the Action and Acceptance Questionnaire-II
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
Change from baseline to immediately after the intervention and 2-month follow-up on the Cognitive Fusion Questionnaire
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale
Time frame: Change from baseline to immediately after the intervention and 2-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Areum Han, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acceptance and commitment therapy (ACT) in people with Depression and Anxiety, run by University of Alabama at Birmingham 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Mar 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 was withdrawn before enrolling participants, so there are no results.
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 from baseline to immediately after the intervention and 2-month follow-up on the Patient Health Questionnaire-9 (time frame: Change from baseline to immediately after the intervention and 2-month follow-up). The study lists 3 primary outcomes in all. 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 2 Mar 2022.