Evaluating the acceptability and effectiveness of internet cognitive behaviour therapy
| ISRCTN | ISRCTN48160673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48160673 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/10/2013
- Registration date
- 04/02/2014
- Last edited
- 10/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Psychology
University of Regina
3737 Wascana Parkway
Regina
S4S 0A2
Canada
| Phone | 1-306-585-5133 |
|---|---|
| hadjista@uregina.ca |
Study information
| Study design | Single-group open trial comparing pre-treatment to post-treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An evaluation of patient access to, satisfaction with, and outcomes resulting from internet cognitive behaviour therapy |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 | Behavioural |
| 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 study start date | 01/10/2010 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 221 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- Canada
Study participating centre
S4S 0A2
Canada
Sponsor information
University/education
c/o Heather Hadjistavropoulos
Department of Psychology
3737 Wascana Parkway
Regina
S4S 0A2
Canada
| Phone | 1-306-585-5133 |
|---|---|
| hadjista@uergina.ca | |
| Website | http://www.onlinetherapyuser.ca |
"ROR" |
https://ror.org/03dzc0485 |
Funders
Funder type
Government
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- SHRF
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Training provided to therapists | 01/08/2012 | Yes | No | |
| Results article | 01/12/2014 | 10/11/2022 | Yes | No |
Editorial Notes
10/11/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
