Emotional Recovery Post-Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
modified Cognitive Behavioral Therapy (mCBT)
BehavioralThe 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
BehavioralIf 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech TherapyExperimental treatment 2 interventions
Group B: Telerehabilitation Occupational or Speech TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.
Time frame
Baseline, pre-intervention and immediately after the intervention, Week 8.2
Patient Specific Functional Scale (PSFS)
A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
Time frame
Baseline, pre-intervention and immediately after the intervention, Week 8.3
Stroke and Aphasia Quality of Life Scale (SAQoL)
39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.
Time frame
Baseline, pre-intervention and immediately after the intervention, Week 8.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
The Duke Endowment
Collaborator
Source ClinicalTrials.gov