search
Back to results

Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Various Course Durations

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wellbeing Course for Students (Fast Track)
Wellbeing Course for Students (5 weeks)
Wellbeing Course (8 weeks)
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring anxiety, depression, post-secondary students, internet-delivered cognitive behaviour therapy, transdiagnostic, preference trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • registered as a student at a post-secondary institution in Saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the PHQ-9) and/or anxiety (score of 5 or greater on the GAD-7); and be able to access computers and the Internet and be comfortable using them

Exclusion Criteria:

  • high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month

Sites / Locations

  • Online Therapy Unit, University of ReginaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Fast-Track Course

5-Week Course

8-Week Course

Arm Description

Clients who select the Fast-Track Course option will receive access to a single ICBT core lesson and Do-It-Yourself guide, followed by three additional Do-It-Yourself guides that they can access in any order. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive up to five weeks of optional therapist support.

Clients who select the 5-week course will receive access to an ICBT course which consists of four lessons spread across the span of five weeks. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive five weeks of optional therapist support.

Clients who select the 8-week course will receive access to an ICBT course which consists of five lessons spread across the span of eight weeks. The content in this course is not student-specific. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive eight weeks of optional therapist support.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire 9-item (PHQ-9)
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder 7-item (GAD-7)
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Perceptions of Academic Functioning (PAF)
Change in subjective academic functioning. 3 items are summed into a total score ranging from 0 to 30, with higher scores indicating higher perceived functioning.

Secondary Outcome Measures

Credibility and Expectancy Questionnaire (CEQ)
Measure of treatment credibility. Three items range from 0-9 with higher scores indicating better outcome.
Treatment Satisfaction
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Work and Social Adjustment Scale (WSAS)
Measure includes 5 questions assessing impairment of functioning. Items are scored on a scale of 0 to 8. Total scores on the WSAS range from 0 to 40 with higher scores suggesting severe impairment.

Full Information

First Posted
April 11, 2022
Last Updated
September 20, 2022
Sponsor
University of Regina
Collaborators
Ministry of Health, Saskatchewan
search

1. Study Identification

Unique Protocol Identification Number
NCT05333627
Brief Title
Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Various Course Durations
Official Title
Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Flexible, 5-Week, and 8-Week Options
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Ministry of Health, Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (ICBT) for post-secondary students with symptoms of depression and anxiety. In ICBT, clients review structured online content over several weeks to learn strategies and skills to manage their symptoms. Low treatment completion rates remain a concern for post-secondary students, so it is possible that existing treatment protocols do not offer enough flexibility for students' needs and preferences. This trial will examine students' preferences for different course options (fast-track, 5-week, and 8-week) and compare enrollment, adherence, and outcomes of students who pick each of the three options. In all three options, students will receive optional therapist support, in which the assigned therapist only contacts the student on weeks where the student sends the therapist a message. This trial will help inform the delivery of flexible treatment options for post-secondary students in a routine care setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
anxiety, depression, post-secondary students, internet-delivered cognitive behaviour therapy, transdiagnostic, preference trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each client will choose one of the following: Wellbeing Course for Students (Fast-Track), Wellbeing Course for Students (5 weeks), and Wellbeing Course (8 weeks)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fast-Track Course
Arm Type
Experimental
Arm Description
Clients who select the Fast-Track Course option will receive access to a single ICBT core lesson and Do-It-Yourself guide, followed by three additional Do-It-Yourself guides that they can access in any order. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive up to five weeks of optional therapist support.
Arm Title
5-Week Course
Arm Type
Experimental
Arm Description
Clients who select the 5-week course will receive access to an ICBT course which consists of four lessons spread across the span of five weeks. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive five weeks of optional therapist support.
Arm Title
8-Week Course
Arm Type
Experimental
Arm Description
Clients who select the 8-week course will receive access to an ICBT course which consists of five lessons spread across the span of eight weeks. The content in this course is not student-specific. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive eight weeks of optional therapist support.
Intervention Type
Behavioral
Intervention Name(s)
Wellbeing Course for Students (Fast Track)
Intervention Description
The core Fast-Track lesson includes information on managing their cycle of symptoms, motivation, and an overview of strategies that can be used to manage symptoms of depression and anxiety. After the core lesson, clients can access three additional Do-It-Yourself guides that focus on thought challenging, controlled breathing/activity planning, and behavioural activation/relapse prevention. These materials are able to be accessed out of sequence on a schedule that suits their needs. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.
Intervention Type
Behavioral
Intervention Name(s)
Wellbeing Course for Students (5 weeks)
Intervention Description
The 5-week course consists of four lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.
Intervention Type
Behavioral
Intervention Name(s)
Wellbeing Course (8 weeks)
Intervention Description
The 8-week course consists of five lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire 9-item (PHQ-9)
Description
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Time Frame
Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Time Frame
Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Title
Perceptions of Academic Functioning (PAF)
Description
Change in subjective academic functioning. 3 items are summed into a total score ranging from 0 to 30, with higher scores indicating higher perceived functioning.
Time Frame
Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Secondary Outcome Measure Information:
Title
Credibility and Expectancy Questionnaire (CEQ)
Description
Measure of treatment credibility. Three items range from 0-9 with higher scores indicating better outcome.
Time Frame
Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)
Title
Treatment Satisfaction
Description
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Time Frame
Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)
Title
Work and Social Adjustment Scale (WSAS)
Description
Measure includes 5 questions assessing impairment of functioning. Items are scored on a scale of 0 to 8. Total scores on the WSAS range from 0 to 40 with higher scores suggesting severe impairment.
Time Frame
Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)
Other Pre-specified Outcome Measures:
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
A 10-item screening tool to assess alcohol consumption. Items 1 to 8 are scored on a scale ranging from 0 to 4. Items 9 and 10 are scored on a three-point scale (0, 2, or 4). Scores from 10 items are summed with possible scores ranging from 0 to 40 and higher scores indicating a higher likelihood of problematic alcohol consumption.
Time Frame
Baseline (screening)
Title
Drug Use Disorder Identification Test (DUDIT)
Description
An 11-item screening tool to assess problematic drug use. Items 1 to 9 are scored on a scale ranging from 0 to 4. Items 10 and 11 are scored as a 0, 2, or 4. Total scores for the DUDIT range from 0 to 44 with higher scores suggesting problematic drug use.
Time Frame
Baseline (screening)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: registered as a student at a post-secondary institution in Saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the PHQ-9) and/or anxiety (score of 5 or greater on the GAD-7); and be able to access computers and the Internet and be comfortable using them Exclusion Criteria: high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcie Nugent, MSW
Phone
3063372946
Email
marcie.nugent@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Hadjistavropoulos, PhD
Phone
3065855133
Email
hadjista@uregina.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Peynenburg, MA
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online Therapy Unit, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcie Nugent, MSW
Phone
3063373331
Email
marcie.nugent@uregina.ca
First Name & Middle Initial & Last Name & Degree
Heather Hadjistavropoulos, PhD

12. IPD Sharing Statement

Learn more about this trial

Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Various Course Durations

We'll reach out to this number within 24 hrs