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

NCT ID: NCT05097040

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-09

Study Completion Date

2022-02-11

Brief Summary

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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

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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

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Depression Anxiety Stress Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Acceptance and commitment therapy (ACT) group

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

Group Type EXPERIMENTAL

acceptance and commitment therapy (ACT)

Intervention Type BEHAVIORAL

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.

Control group

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Areum Han

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Areum Han, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300008160

Identifier Type: -

Identifier Source: org_study_id

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