Clinical trial NCT05243615: Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke
Official title: Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Depression
Anxiety
Keywords: Stroke
Depression
Anxiety
internet-delivered cognitive behaviour therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking care. Internet Cognitive Behavioural Therapy (ICBT) may overcome these barriers. The stroke ICBT program teaches skills such as challenging unhelpful thoughts, memory and attention, managing related physical symptoms, and pacing through a mix of online learning and weekly contact with a trained Guide. While the program's content was found to be acceptable among individuals after stroke, the program's effectiveness still needs to be evaluated. Thus, the primary purpose of this study is to evaluate if the stroke ICBT program will improve symptoms of depression compared to an attention control group. Individuals in both groups will answer questions about themselves and their injury and describe symptoms of depression, quality of life, and health service use to evaluate its impact on people's wellbeing. The study results will be useful in determining if the ICBT program is effective and whether it should be part of routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Canadian residents;
* diagnosed with a stroke at least 6 months ago;
* endorsing symptoms of depression (PHQ-9≥5); 5) suicide risk score \<8 (Suicide Behaviours Questionnaire);
* speak and read English;
* able to access and be comfortable using computers and the internet;
* willing to provide a physician as an emergency contact.

Exclusion Criteria:

* significant cognitive impairment, a score of \<21 on the Telephone Interview for Cognitive Status;
* aphasia, with significant language impairment;
* currently involved in another psychotherapeutic intervention;
* present with a severe mental health disorder requiring in-person therapy (e.g., severe suicidal ideation, severe substance abuse, a recent history of psychosis or mania).

Primary outcomes:
measure: Change in depression
timeFrame: baseline, 10 weeks, 3 months
measure: Change in anxiety
timeFrame: baseline, 10 weeks, 3 months
Secondary outcomes:
measure: Change in quality of life symptoms
timeFrame: baseline, 10 weeks, 3 months
measure: Self-efficacy
timeFrame: baseline, 10 weeks, 3 months
measure: Change in perceived disability
timeFrame: baseline, 10 weeks, 3 months
measure: Treatment credibility
timeFrame: baseline, 10 weeks
measure: Treatment satisfaction
timeFrame: baseline, 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Western University
name: Robert Teasell, MD
role: PRINCIPAL_INVESTIGATOR
References: