ClinicalTrials.gg
Status unknownNCT04667754Updated May 18, 2022

ICBT for Persons With Stroke

An interventional study of Internet-delivered Cognitive Behavioural Therapy in Stroke, Internet-Delivered Cognitive Behavioural Therapy and Depression, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

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.

    Behavioral: Internet-delivered Cognitive Behavioural Therapy

Interventions

  • BehavioralInternet-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.

06

What researchers measure

Primary outcomes

  1. Change in depression

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

    Time frame: Baseline to 3 months

Secondary outcomes

  1. Change in anxiety

    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater Severity of anxiety. Scores range from 0 to 21.

    Time frame: Baseline to 3 months

  2. 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.

    Time frame: Baseline to 3 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04667754
Responsible party
Swati Mehta (Principle Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Dec 16, 2020
Start date
Jun 2022 (estimated)
Primary completion
Jul 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
May 18, 2022

Study contacts

Swati Mehta, PhD
Contact
swati.mehta@sjhc.london.on.ca
519-685-8500 ext. 42359
Alexandria Roa Agudelo
Contact
alexandria.roaagudelo@sjhc.london.on.ca
(519) 646-6100 ext. x42696
Swati Mehta, PhD
principal investigator · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Robert Teasell, MD
principal investigator · St. Joseph's Health Care London

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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