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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Internet-delivered cognitive behaviour therapy
Motivational Interviewing
Booster Session
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, post-secondary students, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centred, therapist-assistance

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 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)

Sites / Locations

  • Online Therapy Unit University of Regina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard ICBT

ICBT with Motivational Interviewing

ICBT with Booster

ICBT with Motivational Interviewing and Booster

Arm Description

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.

Clients assigned to the ICBT with Motivational Interviewing condition will receive the Planning for Change lesson before Lesson 1 of the UniWellbeing Course.

Clients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course.

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).

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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.

Full Information

First Posted
February 7, 2020
Last Updated
November 17, 2021
Sponsor
University of Regina
Collaborators
Saskatchewan Centre for Patient-Oriented Research
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1. Study Identification

Unique Protocol Identification Number
NCT04264585
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
June 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Saskatchewan Centre for Patient-Oriented Research

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
anxiety, depression, post-secondary students, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centred, therapist-assistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard ICBT
Arm Type
Experimental
Arm Description
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.
Arm Title
ICBT with Motivational Interviewing
Arm Type
Experimental
Arm Description
Clients assigned to the ICBT with Motivational Interviewing condition will receive the Planning for Change lesson before Lesson 1 of the UniWellbeing Course.
Arm Title
ICBT with Booster
Arm Type
Experimental
Arm Description
Clients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course.
Arm Title
ICBT with Motivational Interviewing and Booster
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered cognitive behaviour therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Booster Session
Intervention Description
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).
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 1-6, 9, and 17
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 1-6, 9, and 17
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (SDS)
Description
Change in disability. Three items are summed into a total score ranging from 0 to 30, with higher scores indicating higher levels of disability.
Time Frame
Baseline (screening), week 6, 9, and 17
Title
Alcohol Use Disorders 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), week 6, and week 9
Title
Drug Use Disorders 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), week 6, and week 9
Title
Academic functioning
Description
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.
Time Frame
Baseline (screening), weeks 1-6, 9, and 17
Title
Treatment credibility.
Description
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.
Time Frame
Baseline (screening), week 6
Title
Treatment satisfaction
Description
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
Time Frame
Week 6
Title
Change Questionnaire
Description
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.
Time Frame
Pre-treatment

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 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)
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36069785
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.
Results Reference
derived

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

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