Plain English Summary
Background and study aims
Depression and anxiety are common, disabling and under-treated disorders in Canada. Therapist-assisted Internet Cognitive Behavioural Therapy (ICBT) involves patients reviewing therapy materials over the internet while receiving help from a therapist through secure e-mail. Research has consistently shown that ICBT is effective in reducing anxiety and depression. The purpose of this study was to find out the acceptability and effectiveness of ICBT in routine clinical practice.
Who can participate?
Men and women aged 18 years from the Saskatchewan area with symptoms of depression or anxiety and access to a computer.
What does the study involve?
All interested participants participate in a telephone screening to determine if ICBT matches their needs. Screening takes about 60 minutes and asks questions about participants current symptoms and other mental health history. Following the screening, eligible clients receive ICBT immediately. Each online program has 12 treatment modules containing CBT materials that are accessed online, as well as activities that are to be completed offline. Modules include information about the targeted symptoms, how to monitor and challenge unhelpful thoughts, relaxation techniques, behavioural activation, and other coping strategies. Treatment takes a minimum of 12 weeks, although participants can take longer if they wish. All participants are asked to complete questionnaires at the start of the program, mid-way through the program, and immediately following completion of the program.
What are the potential benefits and risks of participating?
The potential benefits include: 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, and 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 ICBT program, 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 started in October 2010 and continued until April 2013.
Who is funding the study?
Canadian Institutes of Health Research and The Saskatchewan Health Research Foundation (Canada).
Who is the main contact?
Dr Heather D. Hadjistavropoulos, Principal Investigator, hadjista@uregina.ca
Ms Marcie Nugent, Unit Coordinator, online.therapy.user@uregina.ca
Trial website
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
An evaluation of patient access to, satisfaction with, and outcomes resulting from internet cognitive behaviour therapy
Acronym
Study hypothesis
1. It is hypothesized that participants who receive Internet Cognitive Behaviour Therapy (ICBT) will demonstrate significant improvement from pre- to post-treatment on symptom outcome measures, with moderate to large, significant, and clinically significant reductions in relevant symptoms.
2. It is hypothesized that approximately 80% of patients offered ICBT will complete all modules in the program.
3. It is hypothesized that over 80% of patients who are offered ICBT will report a high degree of satisfaction with the service.
Ethics approval
1. University of Regina; September 21, 2010; File #: 17R1011
2. University of Saskatchewan; November 30, 2010; File #: BEH-10-294
3. The Regina QuAppelle Health Region; October 1, 2010; REB-10-52
4. Sun Country Health Region; December 7, 2010
5. Cypress Health Region; November 15, 2010
Study design
Single-group open trial comparing pre-treatment to post-treatment
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 (GAD), Panic Disorder
Intervention
Examining the effectiveness of therapist-assisted Internet-based CBT. Participants are selected for each program based on symptom levels.
The interventions are titled GAD Online, Depression Online, and Panic Online, which are ICBT programs designed to treat symptoms of generalized anxiety, depression, and panic respectively. The program consists of 12 treatment modules containing CBT materials that are accessed online, as well as activities that are to be completed offline. All programs begin with information on the targeted disorder. Following this, treatment modules contain a mix of cognitive and behavioural strategies for managing the disorder. For example, information on how to identify and challenge unhelpful thoughts, relaxation techniques, behavioural activation, exposure, and other coping strategies are contained within the modules. Clients should engage in ICBT for approximately 12 weeks. Depression Online, GAD Online, and Panic Online are 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 system built into the program website. In the weekly e-mail, the therapist comments on the progress a client has made, addresses homework concerns, and answers any questions the client has for the therapist. The therapists role is also to provide support, encouragement, and motivation for clients to continue with the program.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Depression Anxiety Stress Scale-21 Item (DASS)
2. Patient Health Questionnaire- 9 Item (PHQ-9)
3. Generalized Anxiety Disorder 7 (GAD-7)
4. Panic Disorder Severity Scale (PDSS)
Measured at baseline, during the study treatment (after the 6th module), at the end of treatment (after the final module) and at 3 months after completing the 12 modules.
Secondary outcome measures
1. World Health Organization Quality of Life Assessment BREF (WHOQOL-BREF)
2. Work and Social Adjustment Scale (WSAS)
3. Treatment Satisfaction questions
4. Therapeutic Alliance Questionnaire (TAQ)
Measured at baseline, during the study treatment (after the 6th module), at the end of treatment (after the final module) and at 3 months after completing the 12 modules.
Overall trial start date
01/10/2010
Overall trial end date
01/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Resident of Saskatchewan
2. Aged 18 years or older, either sex
3. Currently experiencing symptoms of depression, generalized anxiety, or panic
4. Has regular access to a computer, Internet, and printer
5. Comfortable using the internet and writing e-mails
6. For panic: PHQ-9 - score of 5 or above
7. Generalized Anxiety Disorder (GAD)-7 score of 5 or above
8. Panic Disorder Severity Scale (PDSS) score of 6 or above
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
Recruitment start date
01/10/2010
Recruitment end date
01/04/2013
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
Government
Funder name
Canadian Institutes of Health Research (Canada) Partnership for Health Improvement Grant; Reference #: 101526
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Saskatchewan Health Research Foundation (Canada)
Alternative name(s)
SHRF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Canada
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
Basic results (scientific)
Publication list
2012 Training provided to therapists in http://www.ncbi.nlm.nih.gov/pubmed/?term=22428582