ICBT for Persons With Stroke

NCT04667754 | Unknown

• 1 other identifier: 115449
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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.

  Baseline to 3 months

Secondary Outcomes (2)

• Change in anxiety

  Baseline to 3 months

• Change in quality of life

  Baseline to 3 months

Study Arms (1)

10 week ICBT

EXPERIMENTAL

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

Internet-delivered Cognitive Behavioural Therapy BEHAVIORAL

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.

10 week ICBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Swati Mehta, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

• Robert Teasell, MD

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swati Mehta, PhD

CONTACT

519-685-8500; swati.mehta@sjhc.london.on.ca

Alexandria Roa Agudelo

CONTACT

(519) 646-6100; alexandria.roaagudelo@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: June 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05