Clinical trial NCT03684434: Online Cognitive Behaviour Therapy for Depression and Anxiety: Randomized Controlled Trial Varying Treatment Content
Official title: Development and Evaluation of a Brief Online Motivational Interviewing Intervention for Enhancing Engagement in Internet-delivered Cognitive Behaviour Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
Internet-delivered cognitive behaviour therapy
Motivational Interviewing
Randomized controlled trial
Pre-treatment
Mental health system
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-09-25
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in motivation levels
timeFrame: Baseline and week 1
measure: Change in depression symptoms
timeFrame: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
measure: Change in anxiety symptoms
timeFrame: Baseline, weeks 2, 3, 5, 6, 8, 10, 13, 25, and 53
measure: Client engagement in online therapy (i.e., the Wellbeing Course)
timeFrame: week 10
measure: Client feedback questions
timeFrame: week 1 (following completion of the Planning for Change lesson)
measure: Change in motivation to engage in treatment
timeFrame: Monday of week 1 and Sunday of week 1
Secondary outcomes:
measure: NOTE ABOUT SECONDARY MEASURES
timeFrame: weeks 1 to 53
measure: Change in panic symptoms
timeFrame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because PDSS was mistakenly not administered at baseline
measure: Change in social anxiety symptoms
timeFrame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SIAS was mistakenly not administered at baseline
measure: Change in social phobia symptoms
timeFrame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because SPS was mistakenly not administered at baseline
measure: Change in quality of life symptoms
timeFrame: Weeks 2, 10, 13, 25, and 53 **Not used as a secondary measure anymore because EQ-5D-5L was mistakenly not administered at baseline
measure: Psychological Distress
timeFrame: Baseline, weeks 2, 10, 13, 25, and 53 **K10 outcomes were only collected for half the sample during baseline due to the measure accidentally not being included at the start of recruitment. As such, distress was measured using the PHQ-9 and GAD-7 instead.
measure: Change in disability
timeFrame: Baseline, weeks 2, 10, 13, 25, and 53
measure: Change in post-traumatic symptoms
timeFrame: Baseline, weeks 13, 25, and 53
measure: Changes in treatment costs
timeFrame: Baseline, week 13, 25, and 53 **Only used to assess for group differences at baseline**
measure: Change in treatment credibility
timeFrame: Baseline and week 10
measure: Therapeutic alliance
timeFrame: week 10
measure: Satisfaction with Wellbeing Program assessed by the Internet-CBT Treatment Satisfaction Measure
timeFrame: week 10
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: