Clinical trial NCT05097040: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anxiety
Stress
Stroke
Keywords: Acceptance and Commitment Therapy
Stroke
Mindfulness
Psychological health
Self-compassion
Depression
Anxiety
Stress
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Patient Health Questionnaire-9
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Generalized Anxiety Disorder-7
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Perceived Stress Scale
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
Secondary outcomes:
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the World Health Organization Quality of Life - Psychological health component
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Self-Compassion Scale- Short Form
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: 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
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: 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
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Action and Acceptance Questionnaire-II
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Cognitive Fusion Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
measure: Change from baseline to immediately after the intervention and 2-month follow-up on the Engaged Living Scale
timeFrame: Change from baseline to immediately after the intervention and 2-month follow-up
Other outcomes:
measure: Interviews of participants
timeFrame: Immediately after completing 6 weekly ACT sessions
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: