ICBT for Persons With Stroke

• ClinicalTrials.gov Identifier: NCT04667754
• Recruitment Status: Unknown
• First Posted: December 16, 2020
• Last Update Posted: May 18, 2022
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): Swati Mehta, Lawson Health Research Institute

Tracking Information

• First Submitted Date: December 8, 2020
• First Posted Date: December 16, 2020
• Last Update Posted Date: May 18, 2022
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 8, 2020)

Change in depression [ Time Frame: Baseline to 3 months ]

Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 8, 2020)

• Change in anxiety [ Time Frame: Baseline to 3 months ]
  Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater Severity of anxiety. Scores range from 0 to 21.
• Change in quality of life [ Time Frame: Baseline to 3 months ]
  EuroQol five-dimension (EQ-5D) questionnaire. Every dimension of the EQ-5D-5L includes five answer levels, covering no problems (1) to extreme problems (5). Higher numbers indicates poorer quality of life.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ICBT for Persons With Stroke
• Official Title: Internet Delivered Cognitive Behavioural Therapy (ICBT) for Persons With Stroke
• Brief Summary: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke. The aim of the current study is to pilot a tailored ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke living in the community.

Detailed Description

Background: Individuals with stroke can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions.

Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke.

Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke

Methods: In this project, an ICBT program for those with stroke developed through a patient oriented approach will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting.

Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have experienced stroke and mental health concerns.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Stroke
• Internet-Delivered Cognitive Behavioural Therapy
• Depression
• Anxiety

Intervention

Behavioral: Internet-delivered Cognitive Behavioural Therapy

ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.

Study Arms

Experimental: 10 week ICBT

CBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.

Intervention: Behavioral: Internet-delivered Cognitive Behavioural Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 8, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2022
• Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• adults ≥ 18 years
• diagnosed with stroke
• resident of Canada
• access to a computer and the internet
• cognitive capacity to read and understand the content of the program.

Exclusion Criteria:

• High risk of suicide
• Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status (TICS)
• primary problems with psychosis, alcohol or drug problems, mania
• Currently receiving active psychological treatment for anxiety or depression
• Not present in Canada during treatment; 6) Concerns about online therapy
• Physically unable to perform the tasks.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04667754
• Other Study ID Numbers: 115449
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Swati Mehta, Lawson Health Research Institute
• Original Responsible Party: Swati Mehta, Lawson Health Research Institute, Scientist
• Current Study Sponsor: Lawson Health Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Swati Mehta, PhD; Lawson Health Research Institute
• Principal Investigator: Robert Teasell, MD; St. Joseph's Health Care London

• PRS Account: Lawson Health Research Institute
• Verification Date: May 2022