Condition category
Mental and Behavioural Disorders
Date applied
05/11/2013
Date assigned
31/01/2014
Last edited
03/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression and anxiety are common, disabling and undertreated disorders in Canada. Therapist-assisted Internet Cognitive Behavioural Therapy (ICBT) involves patients reviewing therapy materials over the Internet while receiving support and assistance from a therapist through secure e-mail. Research has consistently shown that therapist-assisted ICBT is effective in reducing anxiety and depression. ICBT has now been offered in Saskatchewan, Canada for generalized anxiety disorder, depression, and panic disorder in a 12-module format. Although previous programs were effective in reducing symptoms, feedback suggested that clients wanted a shorter program that could help improve anxiety and depression at the same time.
The Wellbeing Course is a Transdiagnostic ICBT (T-ICBT) program that was originally developed and tested by researchers as the eCentreClinic in Australia. It is referred to as a T-ICBT program because it is designed to treat both depression and anxiety. Research conducted in Australia has shown that depression and anxiety can be effectively treated with the Wellbeing Course. This study will provide and evaluate the eCentreClinic’s Wellbeing treatment program with residents of Saskatchewan, Canada.

Who can participate?
Adults aged 18 and older living in the province of Saskatchewan with symptoms of anxiety, depression, social phobia, or panic.

What does the study involve?
All interested participants will participate in an online screening to determine if T-ICBT matches their needs. Screening takes about 15 to 30 minutes and will ask questions about their current symptoms and other mental health history. Following the screening, eligible clients receive T-ICBT immediately. The T-ICBT program, entitled the Wellbeing Course, is designed to treat symptoms of anxiety and depression among adults. The program consists of five self-led lessons containing CBT materials and additional therapeutic resources that are accessed online. The lessons include information about the symptoms of anxiety and depression, how to identify and challenge unhelpful thoughts, relaxation techniques, behavioural activation strategies, and other coping strategies. Clients should engage in the Wellbeing Course for about 8 weeks. All participants are asked to complete questionnaires at the start of the program, immediately following completion of the program, and 3 months following completion of the program.

What are the potential benefits and risks of participating?
There are several potential benefits associated with participating in the Wellbeing Course. You do not need to schedule an appointment with Internet-based CBT, you avoid having to visit an office if things like transportation, travel, stigma or your own availability are a concern, you can access the online material at a time and location that is convenient to you, you can save and print off program materials for your own review, you can e-mail your therapist at any time through our secure website, you may feel more comfortable disclosing personal information online than in person, and this service is provided free of charge. In addition, this research may help participants manage symptoms of anxiety and depression more effectively. Symptoms of anxiety and depression may also decrease as a result of learning more helpful coping strategies. If the program is found to be effective, it may help other adults who experience anxiety and low mood.
The potential risks or challenges include: assessment and diagnosis may be more difficult when visual cues are not present, potential misinterpretation of e-mail messages between you and your therapist, there is a risk for breaches of confidentiality, there is potential for technology failures that may result in messages not being received by either you or your therapist. As with any form of psychological treatment, there is a small risk of temporary discomfort and/or slight increases in your negative emotions due to increased focus on and awareness of these emotions. However, with the continuation of the Wellbeing Course, these emotions typically lessen and improve as a result of treatment.

Where is the study run from?
The study is run from the Online Therapy Unit for Service, Education, and Research, University of Regina, Canada.

When is the study starting and how long is it expected to run for?
Recruitment for the study began in November 2013 and is expected to continue until June 2015.

Who is funding the study?
Funding has been provided by the Canadian Institutes of Health Research and the Partnership for Health Improvement, Saskatchewan Health Research Foundation, Rx & D Health Research Foundation, Canada.

Who is the main contact?
Dr Heather D. Hadjistavropoulos, Principal Investigator, hadjista@uregina.ca
Marcie Nugent, Unit Coordinator, online.therapy.user@uregina.ca

Trial website

https://www.onlinetherapyuser.ca/wellbeing/

Contact information

Type

Scientific

Primary contact

Dr Heather Hadjistavropoulos

ORCID ID

Contact details

Department of Psychology
University of Regina
3737 Wascana Parkway
Regina
S4S 0A2
Canada
+1 306 585 5133
hadjista@uregina.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Transdiagnostic Internet Cognitive-Behaviour Therapy (T-ICBT) for anxiety and depression

Acronym

Study hypothesis

1. It is predicted that patients who receive T-ICBT will demonstrate significant improvement from pre- to post-treatment on (a) primary outcome measures of anxiety and depression and, (b) secondary outcome measures of social anxiety, stress, and disability.
2. It is expected that over 80% of patients will complete all T-ICBT modules.
3. It is predicted that patients will report a high degree of satisfaction with T-ICBT.
4. It is expected that improvements will be maintained at 3-month follow-up.

Ethics approval

1. University of Regina, 18/01/2013, ref.: 60R1213
2. University of Saskatchewan; 18/01/2013; ref.: BEH 12-348
3. The Regina Qu’Appelle Health Region, 18/01/2013, ref.: REB 12-112
4. Saskatoon Health Region, 26/022013, ref.: BEH- 12-348
5. Five Hills Health Region, 24/05/2013
6. Sun Country Health Region, 06/11/2013
7. Cypress Health Region, 07/10/2013

Study design

Single-group open trial comparing pre-treatment to post-treatment and post-treatment to 3-month follow-up

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression, Generalized Anxiety Disorder, Panic Disorder, Social Phobia

Intervention

Therapist-assisted Transdiagnostic Internet-based CBT.

The intervention is titled the Wellbeing Course, which is a T-ICBT program designed to treat symptoms of anxiety and depression among adults. The program consists of five self-led lessons containing CBT materials that are accessed online. The lessons include information about the symptoms of anxiety and depression, strategies for identifying and changing unhelpful thoughts, strategies for increasing activity, relaxation techniques, and additional coping strategy. Each lesson also includes a “Do It Yourself” Guide which breaks down central concepts and offers additional practice activities. Participants can access several additional resources outlining topics such as assertiveness, communication skills, sleep, and problem solving. The Wellbeing Course is therapist-assisted. Each client is assigned an online therapist who communicates with the client on a weekly basis via e-mail using the secure e-mail built into the program website. In the weekly e-mail, the therapist comments on the progress the client has made, addresses any concerns they client might have, and answers questions regarding application of the concepts and skills learned. The therapist’s role is also to provide support and encouragement as clients progress through the program.

Participants who complete the Wellbeing Course will be contacted three months after completing the program to be asked to complete follow-up measures.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient Health Questionnaire- 9 Item (PHQ-9)
2. Generalized Anxiety Disorder – 7 (GAD-7)

Measured at baseline, immediately following completion of the program, and 3 months following completion of the program.

Secondary outcome measures

1. Social Interaction Anxiety Scale 6-Item and Social Phobia Scale 6-Item Composite (SIAS6/SPS6)
2. Panic Disorder Severity Scale – Self Rating (PDSS-SR)
3. Kessler-10 (K-10)
4. Sheehan Disability Scales (SDS)
5. Working Alliance Inventory – Short Form (WAI-SF)
6. Treatment Satisfaction questions

Measured at baseline, immediately following completion of the program, and 3 months following completion of the program.

Overall trial start date

04/11/2013

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Resident of Saskatchewan
2. Aged 18 years or older, either sex
3. Currently experiencing clinically significant symptoms of depression, anxiety, social phobia, and/or panic
4. Has regular access to a computer, Internet, and printer
5. Comfortable using the Internet and writing e-mails

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Not a resident of Saskatchewan
2. Less than 18 years of age
3. Has no regular access to a computer, Internet, and use of printer
4. Currently receiving psychotherapy elsewhere or in some other form
5. Started a new psychotropic medication within the past month or had a change in dosage
6. Meets criteria for current substance abuse or dependence (drugs or alcohol)
7. Meets current criteria for a psychotic disorder or bipolar disorder, or severe symptoms of depression, including frequent suicidal ideation
8. Has a primary diagnosis of obsessive compulsive disorder or post-traumatic stress disorder, unless T-ICBT can be offered as an adjunct to in person care for these conditions.

Recruitment start date

04/11/2013

Recruitment end date

01/06/2015

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Psychology
Regina
S4S 0A2
Canada

Sponsor information

Organisation

University of Regina (Canada)

Sponsor details

c/o Heather Hadjistavropoulos
Department of Psychology
3737 Wascana Parkway
Regina
S4S 0A2
Canada
+1 306 585 5133
hadjista@uergina.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (Canada) – Partnership for Health Improvement Grant Reference #: 293379

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Research Foundation, Saskatchewan Health Research Foundation (Canada), Reference #: N/A

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Rx & D Health Research Foundation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes