Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT06782321

Conditions

Stroke

Mental Health Wellness 1

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

modified Cognitive Behavioral Therapy (mCBT)

Occupational or Speech Therapy

Study Details

Brief summary:

The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.

Conditions

Stroke

Mental Health Wellness 1

Study ID

NCT06782321

Start date

May 1, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
  • Have experienced ischemic or hemorrhagic stroke at least 30 days prior
  • Stroke-related aphasia and/or upper extremity hemiparesis
  • Aged 21 years or older
  • English as primary language
  • Have corrected vision to be able to read text on a screen
  • Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service
  • Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist

Exclusion Criteria:

  • Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
  • Pain that interferes with ability to participate in the study's upper extremity movement tasks.
  • Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy

active comparator: Telerehabilitation Occupational or Speech Therapy

Interventions

modified Cognitive Behavioral Therapy (mCBT)

The theoretical model underling Cognitive Behavioral Therapy (CBT) explains the interaction of thoughts, feelings, and behaviors during life situations. This model suggests that a person's thoughts/feeling/behaviors affect their functioning during life situations. This contrasts with a common belief that one's functioning during life situations is the only way to effect thoughts/feelings/behaviors. Applied to stroke, this model suggests that the stroke survivor can alter his/her functioning during life situations by altering his/her thoughts/feelings/behaviors. The purpose of CBT is to empower the person with the skills to alter his/her thoughts/feelings/behaviors in order to positively affect function in life situations.

The mCBT intervention includes 4 elements: psychoeducation, education about unhelpful thinking, behavioral activation therapy, education on sleep hygiene, and relaxation training.

Occupational or Speech Therapy

If the participant demonstrates aphasia of any severity level on the Revised Western Aphasia Battery (WAB-R) assessment given at the PRE session, the subject will receive ST, provided by a Speech Language Pathologists (SLP), stroke telerehabilitation. If there is no aphasia, the subject will receive OT stroke telerehabilitation.

The OT and ST stroke telerehabilitation sessions will utilize a similar metacognitive strategy training approach which is focused on enabling the stroke survivor to re-engage with meaningful life activities. In the Occupational Therapy literature this approach is called Cognitive Orientation to Occupational Performance (CO-OP) and in the Speech Language Pathology Literature this approach is called the Life Participation Approach to Aphasia (LPAA).

Telerehabilitation CO-OP and LPAA within the OT or ST session include three common elements: Shared decision-making for goal setting, guidance/coaching from the therapist, and self-evaluation.

Primary outcome measure

  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWS) [ Time Frame: Baseline, pre-intervention and immediately after the intervention, Week 8. ]
  • Patient Specific Functional Scale (PSFS) [ Time Frame: Baseline, pre-intervention and immediately after the intervention, Week 8. ]
  • Stroke and Aphasia Quality of Life Scale (SAQoL) [ Time Frame: Baseline, pre-intervention and immediately after the intervention, Week 8. ]

Central Contacts and Locations

Central contacts

Patricia Finetto

843-792-8533piersonp@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Kelly Rishe, MSOT

843-985-1810callahk@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Rehabilitation Studies
  • Stroke
  • Stroke Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-06-18.