Online Cognitive Behaviour Therapy for Depression and Anxiety: Randomized Controlled Trial Varying Treatment Content
Development and Evaluation of a Brief Online Motivational Interviewing Intervention for Enhancing Engagement in Internet-delivered Cognitive Behaviour Therapy
1 other identifier
interventional
480
1 country
1
Brief Summary
Anxiety and depression are prevalent and disabling conditions. Although cognitive behaviour therapy (CBT) has been shown to significantly reduce symptoms of anxiety and depression, access to the service is limited. Internet-delivered cognitive behaviour therapy (ICBT) represents a novel approach to overcoming access barriers and involves delivering therapeutic content to manage symptoms via structured online lessons. The Online Therapy Unit has been studying the efficacy of ICBT for anxiety and depression and found that \~75% of clients complete treatment and demonstrate large improvement in symptoms. However, recent research suggests that younger clients and clients with higher baseline distress are more likely to dropout of ICBT. While it remains unclear why these clients are more susceptible to attrition, it is plausible that they are experiencing a greater degree ambivalence to change and, thus, terminate treatment as a result. Motivational interviewing (MI) aims to help facilitate clients' intrinsic motivation to change by resolving ambivalence. MI has been integrated into CBT for anxiety to overcome similar concerns of poor treatment retention. Evidence suggests that the integration of MI and CBT further enhances response and completion rates. In the context of online therapy, however, the efficacy of MI remains unclear. In the current trial, the investigators aimed to assess a recently developed online MI pre-treatment (i.e., the Planning for Change lesson). A total of 480 clients (original aim for sample size was 300) applying to transdiagnostic ICBT in routine care were randomly assigned to receive the MI pre-treatment or no pre-treatment (i.e., a waiting period) prior to participating in ICBT (i.e., the Wellbeing Course). The investigators sought to examine: how ICBT with MI compared to standardized ICBT in terms of symptom change, rates of reliable improvement, intervention usage (e.g., number of lessons completed), frequency of motivational language in the first two emails to therapist, and motivation levels. It was hypothesized that there would be a small but significant effect of MI on these variables. Additionally, the investigators aimed to explore if age and severity of baseline distress moderate the effect between MI and ICBT outcomes. Younger clients and clients with higher baseline distress are more likely to drop out of ICBT and, thus, it was further hypothesized that online MI will have a greater impact on these groups.
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 Sep 2018
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
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
September 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2020
CompletedJune 9, 2020
June 1, 2020
1.5 years
September 11, 2018
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in motivation levels
Change Questionnaire - 3 Item: Items are summed into a total score. Total score ranges from 0 to 30, with higher scores representing greater self-reported levels of motivation.
Baseline and week 1
Change in depression symptoms
Patient Health Questionnaire - 9 Item: Items are summed into a total score. Total score ranges from 0 to 27, with higher scores representing more severe self-reported levels of depression.
Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Change in anxiety symptoms
Generalize Anxiety Disorder - 7 Item: Items are summed into a total score. Total score ranges from 0 to 21, with higher scores representing more severe self-reported levels of anxiety.
Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
Client engagement in online therapy (i.e., the Wellbeing Course)
Measured by: Number of lessons completed, number of lesson logins, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client
week 10
Client feedback questions
Administered to only those participants assigned to the Online MI plus ICBT group: A series of rating and open-ended questions developed by the investigators designed to ascertain clients' perceptions of the Planning for Change lesson. Questions are designed to provide both quantitative and qualitative information, and do not include total scores.
week 1 (following completion of the Planning for Change lesson)
Change in motivation to engage in treatment
Two questions developed by Titov et al. (2010) to measure motivation to engage in ICBT: Both questions are rated on a 1 to 9 scale, with higher scores representing greater self-reported motivation levels. Questions will be independently assessed and, thus, there will be no total score.
Monday of week 1 and Sunday of week 1
Secondary Outcomes (12)
NOTE ABOUT SECONDARY MEASURES
weeks 1 to 53
Change in panic symptoms
Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because PDSS was mistakenly not administered at baseline
Change in social anxiety symptoms
Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SIAS was mistakenly not administered at baseline
Change in social phobia symptoms
Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SPS was mistakenly not administered at baseline
Change in quality of life symptoms
Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because EQ-5D-5L was mistakenly not administered at baseline
- +7 more secondary outcomes
Study Arms (2)
Online MI plus Online CBT
EXPERIMENTALAn online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
Online CBT
ACTIVE COMPARATORAn 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
Interventions
An online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
Eligibility Criteria
You may qualify if:
- is 18 years of age or older
- is a resident of Saskatchewan, Canada
- is experiencing at least mild to moderate symptoms of anxiety and/or depression
- has not been hospitalized within the last year for mental health and/or suicide risk concerns
- is not seeking regular face-to-face therapy for anxiety and/or depression
- has access to a secure computer and the Internet
- is comfortable using technology
- is available to work through treatment each week
- is willing to provide a medical contact as emergency contact
You may not qualify if:
- is younger than 18 years of age
- is not a resident of Saskatchewan, Canada
- is experiencing no symptoms of anxiety and/or depression
- has been hospitalized within the last year for mental health and/or suicide risk concerns
- has unmanaged problems with alcohol, drugs, psychosis, or mania
- is seeking regular face-to-face therapy for anxiety and/or depression
- does not have access to a secure computer and the Internet
- is not comfortable using technology
- is not available to work through treatment each week
- is not willing to provide a medical contact as an emergency contact
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Online Therapy Unit
Regina, Saskatchewan, S4S 0A2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather D Hadjistavropoulos, PhD
University of Regina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 25, 2018
Study Start
September 27, 2018
Primary Completion
March 14, 2020
Study Completion
March 14, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06