Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke

Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial

Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking care. Internet Cognitive Behavioural Therapy (ICBT) may overcome these barriers. The stroke ICBT program teaches skills such as challenging unhelpful thoughts, memory and attention, managing related physical symptoms, and pacing through a mix of online learning and weekly contact with a trained Guide. While the program's content was found to be acceptable among individuals after stroke, the program's effectiveness still needs to be evaluated. Thus, the primary purpose of this study is to evaluate if the stroke ICBT program will improve symptoms of depression compared to an attention control group. Individuals in both groups will answer questions about themselves and their injury and describe symptoms of depression, quality of life, and health service use to evaluate its impact on people's wellbeing. The study results will be useful in determining if the ICBT program is effective and whether it should be part of routine clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Stroke; Anxiety
• Intervention / Treatment: Behavioral: Guided internet delivered cognitive behavioural therapy; Behavioral: Stroke rehabilitation mental health education

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Swati Mehta, PhD; Phone Number: 42359 519-661-2111; Email: swati.mehta@sjhc.london.on.ca
• Study Contact Backup: Name: Shannon Janzen; Phone Number: 41295 519-661-2111; Email: shannon.janzen@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older;
• Canadian residents;
• diagnosed with a stroke at least 6 months ago;
• endorsing symptoms of depression (PHQ-9≥5); 5) suicide risk score <8 (Suicide Behaviours Questionnaire);
• speak and read English;
• able to access and be comfortable using computers and the internet;
• willing to provide a physician as an emergency contact.

Exclusion Criteria:

• significant cognitive impairment, a score of <21 on the Telephone Interview for Cognitive Status;
• aphasia, with significant language impairment;
• currently involved in another psychotherapeutic intervention;
• present with a severe mental health disorder requiring in-person therapy (e.g., severe suicidal ideation, severe substance abuse, a recent history of psychosis or mania).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke internet delivered cognitive behavioural therapy; A 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client.	Behavioral: Guided internet delivered cognitive behavioural therapy; A 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client.
Active Comparator: Stroke Rehabilitation Education; A 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client.	Behavioral: Stroke rehabilitation mental health education; A 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression	Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes	baseline, 10 weeks, 3 months
Change in anxiety	Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes	baseline, 10 weeks, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life symptoms	Measured by VAS on the EuroQol-5D (EQ5D), higher scores indicate better outcomes	baseline, 10 weeks, 3 months
Self-efficacy	Measured by Self-Efficacy for managing Chronic Disease-6 (SEMCD), higher scores indicate better outcomes	baseline, 10 weeks, 3 months
Change in perceived disability	Measured by The World Health Organization Disability Assessment Schedule ,(WHODAS), higher scores indicate worse outcomes	baseline, 10 weeks, 3 months
Treatment credibility	Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.	baseline, 10 weeks
Treatment satisfaction	Measured by Internet-CBT Treatment Satisfaction Measure, higher scores indicate greater satisfaction	baseline, 10 weeks

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Robert Teasell, MD, Western University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Stroke; Anxiety; internet-delivered cognitive behaviour therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Depression
• Other Study ID Numbers: 12132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No