Transdiagnostic iCBT for Depression and Anxiety

NCT02266693 | Completed DMC

• 1 other identifier: 057/2012
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cognitive Behavioural Therapy; Internet Based; CBT; Transdiagnostic; MDD; PD; SAD; GAD; iCBT

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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)

Study Arms (2)

ICBT Group

EXPERIMENTAL

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

Waitlist Group

NO INTERVENTION

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.

Interventions

iCBT 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.

Also known as: Internet based Cognitive Behavioural Therapy

ICBT Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range (18-29 years).
• Primary diagnosis of MDD, SAD, PD and/or GAD, per the DSM-IV-TR.
• A score ≥17 on the first 17 items of the Hamilton Depression Rating Scale (HAM-D)55
• A score ≥17 on the Hamilton Anxiety Rating Scale (HAM-A)56.
• 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
• Currently unmedicated or on stable and adequate doses of medication for at least 4 weeks.
• Co-morbidities are allowed and will be documented.

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders

Study Officials

• Arun Ravindran, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CA (1)