Transdiagnostic iCBT for Depression and Anxiety

NCT ID: NCT02266693

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-08-31

Brief Summary

This 8-week, pilot randomized, controlled trial to evaluate the benefits of transdiagnostic Internet-based CBT (iCBT) in young adults with MDD, SAD, PD or GAD. The investigators hypothesize that patients who receive iCBT will show significant improvement in anxiety symptoms and functioning, compared to a wait-list group. This pilot randomized controlled study will assess the efficacy of transdiagnostic iCBT in 60 young adults.

Detailed Description

Unipolar depression and anxiety disorders (particularly social anxiety disorder [SAD], generalized anxiety disorder [GAD] and panic disorder [PD]) are among the most common forms of mental illnesses. They often have a chronic course, and are frequently associated with co-morbidities, significant disability, and poor quality of life. Published epidemiologic studies indicate that these conditions typically emerge during early adolescence and adulthood, and are often poorly recognized, resulting in delay of several years before help is sought. Such delay is often attributed to the non-recognition of the significance of the symptoms, lack of information on or access to services, and embarrassment and fear of stigma, but each effective early treatment can reduce co-morbidities and improve prognosis.

Cognitive behaviour therapy (CBT) is recognized as the single most effective psychological intervention for depression and anxiety, but accessibility is affected by therapist costs and long wait times for OHIP-covered services. Internet-based CBT (iCBT) is an innovative alternative with higher accessibility and cost-efficiency than group CBT, but with comparable efficacy. Transdiagnostic models of iCBT that treat depression, SAD, PD and GAD within one program have shown efficacy in preliminary trials and may offer even greater accessibility and economy, as several depressed and anxious populations can be treated with the same protocol. As a non-pharmacological treatment option enhanced by technological advances, iCBT is likely to appeal to tech-savvy young adults. However, it has not been evaluated specifically in a young adult population, thus far.

This 8-week, multi-site, randomized, controlled trial to evaluate the benefits of trandiagnostic iCBT in 60 young adults with unipolar depression and/or SAD, PD or GAD. We hypothesize that patients who receive iCBT will show significant improvement in depressive and anxiety symptoms and functioning, compared to a wait-list group.

Conditions

Major Depressive Disorder; Social Anxiety Disorder; Panic Disorder; Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICBT Group

The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.

Group Type: EXPERIMENTAL

iCBT

Intervention Type: BEHAVIORAL

The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.

Waitlist Group

Upon completion of the 8-week study wait-list period (i.e. their study participation), the opportunity to participate in iCBT, outside the study framework will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iCBT

The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet based Cognitive Behavioural Therapy

Eligibility Criteria

Inclusion Criteria

1. Age range (18-29 years).

2. Primary diagnosis of MDD, SAD, PD and/or GAD, per the DSM-IV-TR.

3. A score ≥17 on the first 17 items of the Hamilton Depression Rating Scale (HAM-D)55

4. A score ≥17 on the Hamilton Anxiety Rating Scale (HAM-A)56.

5. Score ≥50 on the Leibowitiz Social Anxiety Scale (LSAS),57 ≥10 on the Panic Disorder Severity Scale (PDSS)58 and/or ≥60 the Penn State Worry Questionnaire (PSWQ).59

6. Currently unmedicated or on stable and adequate doses of medication for at least 4 weeks.

7. Co-morbidities are allowed and will be documented.

Exclusion Criteria

1. Primary diagnosis of any psychotic disorder or any other anxiety disorder (OCD, PTSD).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Arun Ravindran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Ravindran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health

Other Identifiers

057/2012

Identifier Type: -

Identifier Source: org_study_id