Internet-delivered Cognitive Behaviour Therapy (ICBT) for Post-secondary Students

Depression Clinical Trial

Official title:

Examining Motivational Interviewing and Booster Sessions in Internet-delivered Cognitive Behaviour Therapy for Post-secondary Students: An Implementation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264585
• Other study ID #: 2019-205
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: June 26, 2021

Study information

• Verified date: November 2021
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: June 26, 2021
• Est. primary completion date: June 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Internet-delivered cognitive behaviour therapy
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.
• Motivational Interviewing
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.
• 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. 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).

Locations

Country	Name	City	State
Canada	Online Therapy Unit University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Saskatchewan Centre for Patient-Oriented Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sheehan Disability Scale (SDS)	Change in disability. Three items are summed into a total score ranging from 0 to 30, with higher scores indicating higher levels of disability.	Baseline (screening), week 6, 9, and 17
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	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.	Baseline (screening), week 6, and week 9
Secondary	Drug Use Disorders Identification Test (DUDIT)	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.	Baseline (screening), week 6, and week 9
Secondary	Academic functioning	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.	Baseline (screening), weeks 1-6, 9, and 17
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 (screening), week 6
Secondary	Treatment satisfaction	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	Week 6
Secondary	Change Questionnaire	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.	Pre-treatment