ICBT for Persons With Stroke

• ClinicalTrials.gov Identifier: NCT04667754
• Recruitment Status: Not yet recruiting
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Internet-Delivered Cognitive Behavioural Therapy; Depression; Anxiety	Behavioral: Internet-delivered Cognitive Behavioural Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet Delivered Cognitive Behavioural Therapy (ICBT) for Persons With Stroke
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Swati Mehta, PhD; 519-685-8500 ext 42359; swati.mehta@sjhc.london.on.ca

Contact: Alexandria Roa Agudelo; (519) 646-6100 ext x42696; alexandria.roaagudelo@sjhc.london.on.ca

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

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

More Information

• Responsible Party: Swati Mehta, Principle Investigator, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04667754
• Other Study ID Numbers: 115449
• First Posted: December 16, 2020
• Last Update Posted: May 18, 2022
• Last Verified: May 2022

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

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases