Clinical trial NCT04264585: Internet-delivered Cognitive Behaviour Therapy (ICBT) for Post-secondary Students
Official title: Examining Motivational Interviewing and Booster Sessions in Internet-delivered Cognitive Behaviour Therapy for Post-secondary Students: An Implementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: anxiety
depression
post-secondary students
internet-delivered cognitive behaviour therapy
randomized controlled trial
patient-centred
therapist-assistance
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Centre for Patient-Oriented Research
First posted: 2020-02-11
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

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)

Primary outcomes:
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline (screening), weeks 1-6, 9, and 17
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (screening), weeks 1-6, 9, and 17
Secondary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline (screening), week 6, 9, and 17
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline (screening), week 6, and week 9
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline (screening), week 6, and week 9
measure: Academic functioning
timeFrame: Baseline (screening), weeks 1-6, 9, and 17
measure: Treatment credibility.
timeFrame: Baseline (screening), week 6
measure: Treatment satisfaction
timeFrame: Week 6
measure: Change Questionnaire
timeFrame: Pre-treatment
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Vanessa Peynenburg, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.