ICBT for Persons With Stroke

Stroke Clinical Trial

Official title:

Internet Delivered Cognitive Behavioural Therapy (ICBT) for Persons With Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04667754
• Other study ID #: 115449
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: July 2022

Study information

• Verified date: May 2022
• Source: Lawson Health Research Institute
• Contact: Swati Mehta, PhD
• Phone: 519-685-8500
• Email: swati.mehta[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.	Baseline to 3 months
Secondary	Change in anxiety	Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater Severity of anxiety. Scores range from 0 to 21.	Baseline to 3 months
Secondary	Change in quality of life	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.	Baseline to 3 months