Transdiagnostic iCBT for Depression and Anxiety

Efficacy of Transdiagnostic Internet-based CBT for Early Illness Unipolar Depression and Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Panic Disorder
• Intervention / Treatment: Behavioral: iCBT

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Internet based Cognitive Behavioural Therapy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hamilton Depression Rating Scale (HAM-D) Total Score	Baseline to study endpoint (Week 8)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score	Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score	Baseline to study endpoint (Week 8)
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score	Baseline to study endpoint (Week 8)
Change in Panic Disorder Severity Scale Total Score	Baseline to study endpoint (Week 8)
Change in Penn State Worry Questionnaire Total Score	Baseline to study endpoint (Week 8)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score	Baseline to study endpoint (Week 8)
Change in Sheehan Disability Scale (SDS) Total Score	Baseline to study endpoint (Week 8)
Change in Clinical Global Impression (CGI)	Baseline to study endpoint (Week 8)

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: MDD; CBT; Cognitive Behavioural Therapy; Internet Based; SAD; PD; GAD; Transdiagnostic; iCBT
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Phobic Disorders; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major; Phobia, Social; Panic Disorder
• Other Study ID Numbers: 057/2012