Internet-delivered Cognitive Behaviour Therapy (ICBT) for Post-secondary Students
- Conditions
- AnxietyDepression
- Interventions
- Behavioral: Internet-delivered cognitive behaviour therapyBehavioral: Motivational InterviewingBehavioral: Booster Session
- Registration Number
- NCT04264585
- Lead Sponsor
- University of Regina
- 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.
- Detailed Description
The aims of the study will be to: assess the efficacy of the UniWellbeing Course in reducing symptoms of anxiety and depression and increasing adjustment to academic and social responsibilities; to assess the impact of a pre-treatment motivational interviewing component on attrition, engagement, and outcomes (depression, anxiety, and academic functioning); to assess the impact of a booster session on anxiety, depression, and academic and social adjustment at three-month follow-up; and to assess the combined effect of including both a motivational interviewing component and booster session on outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 308
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description ICBT with Motivational Interviewing Motivational Interviewing Clients assigned to the ICBT with Motivational Interviewing condition will receive the Planning for Change lesson before Lesson 1 of the UniWellbeing Course. ICBT with Motivational Interviewing Internet-delivered cognitive behaviour therapy Clients assigned to the ICBT with Motivational Interviewing condition will receive the Planning for Change lesson before Lesson 1 of the UniWellbeing Course. ICBT with Motivational Interviewing and Booster Motivational Interviewing Clients 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). ICBT with Motivational Interviewing and Booster Booster Session Clients 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). Standard ICBT Internet-delivered cognitive behaviour therapy Clients 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 and Booster Internet-delivered cognitive behaviour therapy Clients 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). ICBT with Booster Internet-delivered cognitive behaviour therapy Clients 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 Booster Booster Session Clients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course.
- Primary Outcome Measures
Name Time Method Patient Health Questionnaire 9-item (PHQ-9) Baseline (screening), weeks 1-6, 9, and 17 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) Baseline (screening), weeks 1-6, 9, and 17 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.
- Secondary Outcome Measures
Name Time Method Treatment credibility. Baseline (screening), week 6 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.
Treatment satisfaction Week 6 Measured by Internet-CBT Treatment Satisfaction Measure. Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Alcohol Use Disorders Identification Test (AUDIT) Baseline (screening), week 6, and week 9 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.
Change Questionnaire Pre-treatment The CQ is a self-report measure that focuses on three factors of change: importance, ability, and commitment. For the purpose of this study, the desired change will be to "reduce the anxiety and/or depression I experience". For each of the three factors, participants are asked to rate on a scale of 0 ("Definitely not") to 10 ("Definitely") how motivated they are to make the change. Total scores on the questionnaire can range from 0 to 30.
Drug Use Disorders Identification Test (DUDIT) Baseline (screening), week 6, and week 9 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.
Academic functioning Baseline (screening), weeks 1-6, 9, and 17 Self-report measure of self-efficacy for academic functioning/skills. Items are scored from 0-10, with higher scores indicating higher levels of perceived self-efficacy.
Sheehan Disability Scale (SDS) Baseline (screening), week 6, 9, and 17 Change in disability. Three items are summed into a total score ranging from 0 to 30, with higher scores indicating higher levels of disability.
Trial Locations
- Locations (1)
Online Therapy Unit University of Regina
🇨🇦Regina, Saskatchewan, Canada