Online Cognitive Behaviour Therapy for Depression and Anxiety: Randomized Controlled Trial Varying Treatment Content

University of Regina

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Online MI plus Online CBT; Behavioral: Online CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03684434

2018-084

Details and patient eligibility

About

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.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Online MI plus Online CBT

Experimental group

Description:

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.

Treatment:

Behavioral: Online MI plus Online CBT

Online CBT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Online CBT