Internet-delivered Cognitive Behaviour Therapy (ICBT) for Post-secondary Students
Examining Motivational Interviewing and Booster Sessions in Internet-delivered Cognitive Behaviour Therapy for Post-secondary Students: An Implementation Trial
1 other identifier
interventional
308
1 country
1
Brief Summary
Post-secondary students are at an elevated risk for anxiety and depression, with approximately one in three students experiencing clinical levels of symptoms at some point during their academic career. Despite the high prevalence of these mental health concerns, many students do not receive adequate treatment. Internet-delivered cognitive behaviour therapy (ICBT) is an alternative to face-to-face service that is effective for improving symptoms of anxiety and depression in general adult populations. Recently, there has been increasing interest in the use of ICBT in post-secondary populations, however high drop-out rates and small effect sizes suggest that current ICBT programs are not fully meeting students' specific needs. Additional research is necessary to ensure that ICBT is delivered to students in a manner that is both acceptable and effective. The proposed study will be an implementation trial to examine whether the efficacy of an ICBT course for post-secondary students is improved by offering a motivational interviewing component at pre-treatment and a booster session 1-month after completing treatment. Follow-up assessment will be conducted as 3-month post-treatment. Primary outcomes are anxiety, depression, and academic functioning. Implementation outcomes will include measures of the acceptability, adoption, and fidelity (assessed by number of modules completed) of the ICBT course.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Feb 2020
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
February 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2021
CompletedNovember 18, 2021
November 1, 2021
1.3 years
February 7, 2020
November 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (screening), weeks 1-6, 9, and 17
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.
Baseline (screening), weeks 1-6, 9, and 17
Secondary Outcomes (7)
Sheehan Disability Scale (SDS)
Baseline (screening), week 6, 9, and 17
Alcohol Use Disorders Identification Test (AUDIT)
Baseline (screening), week 6, and week 9
Drug Use Disorders Identification Test (DUDIT)
Baseline (screening), week 6, and week 9
Academic functioning
Baseline (screening), weeks 1-6, 9, and 17
Treatment credibility.
Baseline (screening), week 6
- +2 more secondary outcomes
Study Arms (4)
Standard ICBT
EXPERIMENTALClients assigned to the Standard ICBT condition will receive the standard version of the ICBT course, which consists of four lessons spread across the span of five weeks. Clients will receive five weeks of therapist support.
ICBT with Motivational Interviewing
EXPERIMENTALClients assigned to the ICBT with Motivational Interviewing condition will receive the Planning for Change lesson before Lesson 1 of the UniWellbeing Course.
ICBT with Booster
EXPERIMENTALClients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course.
ICBT with Motivational Interviewing and Booster
EXPERIMENTALClients assigned to the ICBT with Motivational Interviewing and Booster condition will receive access to both the Motivational Interviewing content (before Lesson 1 of the UniWellbeing Course) and the booster session (one month after ICBT course).
Interventions
All clients will receive the same materials, namely the UniWellbeing Course, which was developed at Macquarie University, Australia. The UniWellbeing Course is a transdiagnostic intervention targeting symptoms of depression and anxiety, that has been tailored for use in post-secondary students. It comprises 4 online lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model; thought monitoring and challenging; de-arousal strategies and pleasant activity scheduling; graduated exposure; and relapse prevention. Seven supplementary lessons can also be accessed at any time (e.g., sleep, communication). Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) with 4 lesson summaries and homework assignments that facilitate skill acquisition. Therapists will spend \~15 mins. per week/per client.
Clients assigned to the ICBT with Motivational Interviewing condition will receive access to the Planning for Change lesson before accessing Lesson 1. They will be presented with five interactive online exercises based on motivational interviewing principles (i.e. values clarification, importance ruler, looking back, confidence ruler, and looking forward). As clients complete the exercises, they are prompted to answer open-ended questions and are provided with written feedback.
Clients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course. The booster session will include information about maintaining motivation, a review of the ICBT course content and skills, and information about structured problem solving. Clients will also have access to a Do-It-Yourself guide that summarizes the information in the booster session and includes worksheets for clients to practice the problem-solving skills described in the booster. This booster session will be self-guided (ie. no therapist support is offered).
Eligibility Criteria
You may qualify if:
- registered as a student at a post-secondary institution in Saskatchewan; over the age of 18;endorse symptoms of depression and/or anxiety; be able to access computers and the Internet and be comfortable using them; and willing to provide a physician as an emergency contact
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Online Therapy Unit University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
Related Publications (1)
Peynenburg V, Hadjistavropoulos H, Thiessen D, Titov N, Dear B. Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons. J Med Internet Res. 2022 Sep 7;24(9):e40637. doi: 10.2196/40637.
PMID: 36069785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Peynenburg, MA
University of Regina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
February 28, 2020
Primary Completion
June 26, 2021
Study Completion
June 26, 2021
Last Updated
November 18, 2021
Record last verified: 2021-11