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

NCT05097040 | Withdrawn

• 1 other identifier: IRB-300008160
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Stress; Stroke

Keywords

Acceptance and Commitment Therapy; Stroke; Mindfulness; Psychological health; Self-compassion; Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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.

  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

  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

  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

  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

  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

  Change from baseline to immediately after the intervention and 2-month follow-up

Other Outcomes (1)

• Interviews of participants

  Immediately after completing 6 weekly ACT sessions

Study Arms (2)

Acceptance and commitment therapy (ACT) group

EXPERIMENTAL

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

Behavioral: acceptance and commitment therapy (ACT)

Control group

NO INTERVENTION

Care as usual

Interventions

acceptance and commitment therapy (ACT) 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.

Acceptance and commitment therapy (ACT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stroke; Psychological Well-Being

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 27, 2021
• Study Start: January 9, 2022
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)