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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05097040
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Withdrawn
Phase N/A
Start date January 9, 2022
Completion date February 11, 2022

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