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Transdiagnostic iCBT for Depression and Anxiety

Primary Purpose

Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iCBT
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Cognitive Behavioural Therapy, Internet Based, CBT, Transdiagnostic, MDD, PD, SAD, GAD, iCBT

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICBT Group

Waitlist Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Change in Panic Disorder Severity Scale Total Score
Change in Penn State Worry Questionnaire Total Score

Secondary Outcome Measures

Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score
Change in Sheehan Disability Scale (SDS) Total Score
Change in Clinical Global Impression (CGI)

Full Information

First Posted
October 7, 2014
Last Updated
February 13, 2019
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02266693
Brief Title
Transdiagnostic iCBT for Depression and Anxiety
Official Title
Efficacy of Transdiagnostic Internet-based CBT for Early Illness Unipolar Depression and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Generalized Anxiety Disorder
Keywords
Cognitive Behavioural Therapy, Internet Based, CBT, Transdiagnostic, MDD, PD, SAD, GAD, iCBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICBT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iCBT
Other Intervention Name(s)
Internet based Cognitive Behavioural Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Panic Disorder Severity Scale Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Penn State Worry Questionnaire Total Score
Time Frame
Baseline to study endpoint (Week 8)
Secondary Outcome Measure Information:
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Sheehan Disability Scale (SDS) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Clinical Global Impression (CGI)
Time Frame
Baseline to study endpoint (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Primary diagnosis of any psychotic disorder or any other anxiety disorder (OCD, PTSD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Ravindran, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health

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Transdiagnostic iCBT for Depression and Anxiety

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