Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke

Stroke Clinical Trial

Official title:

Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05243615
• Other study ID #: 12132
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: Swati Mehta, PhD
• Phone: 519-661-2111
• Email: swati.mehta[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stroke

Intervention

Behavioral:
• Guided internet delivered cognitive behavioural therapy
A 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client.
• Stroke rehabilitation mental health education
A 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client.

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	Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes	baseline, 10 weeks, 3 months
Primary	Change in anxiety	Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes	baseline, 10 weeks, 3 months
Secondary	Change in quality of life symptoms	Measured by VAS on the EuroQol-5D (EQ5D), higher scores indicate better outcomes	baseline, 10 weeks, 3 months
Secondary	Self-efficacy	Measured by Self-Efficacy for managing Chronic Disease-6 (SEMCD), higher scores indicate better outcomes	baseline, 10 weeks, 3 months
Secondary	Change in perceived disability	Measured by The World Health Organization Disability Assessment Schedule ,(WHODAS), higher scores indicate worse outcomes	baseline, 10 weeks, 3 months
Secondary	Treatment credibility	Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.	baseline, 10 weeks
Secondary	Treatment satisfaction	Measured by Internet-CBT Treatment Satisfaction Measure, higher scores indicate greater satisfaction	baseline, 10 weeks