DepressionNCT02423733
Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial
A study testing The Journal in people with Depression, run by University of Ottawa at 1 site in Canada.
Trial summary
Depression is common and disabling but access to specialist treatment is often delayed with waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE (The National… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Depression
- What is being tested?
- The Journal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years of age or older .
- Referred to the Youth, Geriatric, or Mood and Anxiety Psychiatry Programs at the Royal Ottawa Mental Health Centre for any depressive symptoms.
- Has been triaged to the Youth, Geriatric, or Mood and Anxiety Psychiatry Programs at the Royal Ottawa Mental Health Centre.
Who cannot join
- Is unable to read or write in English
- Has cognitive impairments that render participant unable to use a computer
- Does not have access to a computer
- Does not have an OHIP number
Trial locations and contacts
1 site in 1 country.
About this study
Depression is common and disabling but access to specialist treatment is often delayed with waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE (The National Institute for Health and Clinical Excellence) and others about the importance of non-drug therapies. One way to address this problem is to use computerized e-therapies which deliver structured cognitive behavioral treatment where the therapy can be accessed in a location and at a time that is convenient for patients and where there is no waiting list. Previous randomized controlled trials of e-therapies for depression have mainly been in people recruited through the internet or in clinical populations with mild disorders where many participants do not complete the on-line course. Despite this there is some evidence that clinician-assisted computerized cognitive behavior therapy can result in significant improvements in depression with reduced demands on clinician time. To date there have been no trials of clinician assisted e-therapy in secondary care.
Therefore the aim of this clinical trial is to answer the question "In patients on the waiting list for the mood program does a computerized therapy with an e-therapy coach compared to written information about depression and the availability of computerized treatments result in better outcomes, quicker improvements and the use of fewer resources after 12 weeks". The study will be a randomized controlled trial with health service use and PHQ-9 as the main outcome measures.
Read the detailed description
Depression is common and disabling but the evidence is that fewer than half of people with depression seek any treatment and few receive any help from specialized mental health professionals (1). In secondary care treatment is often limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE and others about the importance of non-drug therapies (2). At The Royal Ottawa Health Care Group the waiting time to be seen in the Mood Program is between nine months and a year. One way to address this problem is to use computerized e-therapies which deliver structured cognitive behavioral treatment via a computer (3). The appeal of e-therapies is that they solve several problems. Firstly they are convenient for users. They can be used at any time and can be accessed in different locations. Secondly there is no waiting for appointments. Last for health providers they address the workforce issue of a lack of trained providers of effective interventions. If e-therapies can be shown to be acceptable, feasible and effective there is no reason why these computerized therapies could not replace humans leaving qualified professionals to focus on more complex management problems. This may lead to the development of new role which in this proposal is an e-therapy coach.
Previous randomized controlled trials of e-therapies for depression have mainly been in people recruited through the internet or in clinical populations with mild or "sub-clinical" disorders(4). The difficulty with these populations is that there is a high rate of spontaneous remission. However systematic reviews have consistently found a significant moderate effect of computerized therapies in reducing depressive symptoms compared to control conditions (5, 6). A further problem is that many people fail to complete the course of e-therapy (although this also applies to face to face therapies). There is a need for randomized controlled trials of e-therapies in clinical populations using novel techniques to maximize the dose of e-therapy without losing the potential health workforce benefits.
A potentially attractive solution is to enable clinician-assisted computerized cognitive behavior therapy. For this proposal the investigators plan to use an e-therapy coach who would coach people through the on-line therapy. In this model the clinician acts in the role of a coach to support the patient progress through the computerized treatment - the clinician does not need to deliver the non-drug therapy themselves. There is some evidence that this can result in significant improvements in depression with reduced demands on clinician time(7). However previous trials have been done using participants with relatively less severe depression who may not have seen clinicians as part of their usual care (8). Also the outcome measures are usually only self-rating scales rather than objective measures of function. To date there have been no trials of clinician assisted e-therapy in secondary care.
"The Journal" (9) a free internet based program for the self-management of depression (www.depression.org.nz) was developed in New Zealand and capitalizes on the social marketing appeal of Sir John Kirwan, an ex All Black who has described his experiences of depression to help destigmatize mental illness. However in Canada John Kirkan is unknown so one hypothesis the investigators will test in this study is whether the social marketing by a celebrity is necessary for the effective use of an e-therapy. The self-help program is based on the cognitive behavioral techniques of behavioral activation and problem solving which teaches patients the skills of problem solving and delivers an evidence based intervention which is personalized for their individual care. The problem solving approach was derived from a large randomized control trial of face to face problem solving used in people who presented to emergency departments with intentional self-harm (10).
Usage data from New Zealand shows that the depression.org web site was visited by 700,000 people in its first year (the population of New Zealand is 4.2 million) with 20,000 registered with The Journal and 13,000 active users. About 1500 people a month register to start the program with about three quarters of people recording significant improvement. Although the program was designed for depression of mild to moderate severity the evidence shows that nearly a third of people who access the program have more severe depression. The mean PHQ-9 score at the start of the program is 16 which reduces to 10 after 3 sessions and 7 by the end of the program. The change in depression scores is most marked for severe depression with only 5% of people scoring in the severe range at the end of the program.
- Conditions
- Depression
- Being tested
- The Journal
- Keywords
- depression, dysthymia, cognitive behavioural therapy, CBT, problem-solving therapy, PST, waitlist, secondary mental health care, mental health, e-therapy, computerized therapy
- Medical subject headings
- Depression, Dysthymic Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The JournalOther
"The Journal" is a free internet based program for the self-management of depression (www.depression.org.nz) that was developed in New Zealand and capitalizes on the social marketing appeal of Sir John Kirwan, an ex All Black who has described his experiences of depression to help destigmatize mental illness. . The self-help program is based on the cognitive behavioral techniques of behavioral activation and problem solving which teaches patients the skills of problem solving and delivers an evidence based intervention which is personalized for their individual care.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In addition to their usual clinical care will also be given written information about web sites that provide information on depression but will not be specifically directed to The Journal. |
| Computerized Therapy | Experimental | In addition to their usual clinical care they will receive an invitation to use The Journal supported by an e-therapy coach who will provide patients with weekly email or telephone contact. The e-therapy coach will have a guideline script for each lesson of The Journal to reinforce the topic of each lesson, help identify and support patients in their goals and to coach them in goal setting and the techniques of problem solving. Receives: Other: The Journal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scores on PHQ-9 Scale
Measures severity of depressive symptoms.
Measured: Baseline, 2, 6 and 12 weeks
Secondary outcomes (7)
Change in Scores on SF-12 Scale
A generic measure of function and well being
Measured: Baseline, 6 and 12 weeks
Change in Scores on EQ-5D Scale
A generic health-related quality of life index that can be related to costs
Measured: Baseline, 6 and 12 weeks
Internet Use Questionnaire
Record of internet resources used relating to health concerns assessed by self-report
Measured: 12 weeks
Time Off Work Questionnaire
To assess cost of treatment
Measured: 12 weeks
Hospital Admission from ICES data
To assess cost of treatment
Measured: 12 weeks
Outpatient appointments from ICES data
To assess cost of treatment
Measured: 12 weeks
Medication use from ICES data
To assess cost of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Simon Hatcher, University of Ottawa
- Investigators
- Simon Hatcher, MD., Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423733
- Sponsor's protocol ID
- 2014001
- Status last verified
- Dec 2018
- First submitted
- 13 Apr 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Andrews G, Titov N. Depression is very disabling. Lancet. 2007 Sep 8;370(9590):808-9. doi: 10.1016/S0140-6736(07)61393-2. No abstract available.
PubMed 17826154Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
PubMed 20183695So M, Yamaguchi S, Hashimoto S, Sado M, Furukawa TA, McCrone P. Is computerised CBT really helpful for adult depression?-A meta-analytic re-evaluation of CCBT for adult depression in terms of clinical implementation and methodological validity. BMC Psychiatry. 2013 Apr 15;13:113. doi: 10.1186/1471-244X-13-113.
PubMed 23587347Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One. 2010 Jun 8;5(6):e10939. doi: 10.1371/journal.pone.0010939.
PubMed 20544030Hatcher S, Sharon C, Parag V, Collins N. Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):310-6. doi: 10.1192/bjp.bp.110.090126. Epub 2011 Aug 4.
PubMed 21816868Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Depression: Evidence Update April 2012: A summary of selected new evidence relevant to NICE clinical guideline 90 'The treatment and management of depression in adults' (2009) [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2012. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552056/
PubMed 31886986Marks I, Cavanagh K, Gega L. Hands-on help: Computer-aided psychotherapy. Psychology Press Taylor and Francis, 2007
Cowpertwait L, Clarke D. Effectiveness of web-based psychological interventions for depression: A meta analysis. International Journal of Mental Health and Addiction. 2013; 11: 247-68
Vernmark K, Lenndin J, Bjarehed J, Carlsson M, Karlsson J, Oberg J, Carlbring P, Eriksson T, Andersson G. Internet administered guided self-help versus individualized e-mail therapy: A randomized trial of two versions of CBT for major depression. Behav Res Ther. 2010 May;48(5):368-76. doi: 10.1016/j.brat.2010.01.005. Epub 2010 Feb 2.
PubMed 20152960Ministry of Health. 2009. www.depression.org.nz.
MacLean S, Corsi DJ, Litchfield S, Kucharski J, Genise K, Selaman Z, Testa V, Hatcher S. Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 9;22(6):e15001. doi: 10.2196/15001.
PubMed 32515740
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02423733
- Acronym / sponsor ID
- 2014001
- Conditions
- Depression
- Keywords
- depression, dysthymia, cognitive behavioural therapy, CBT, problem-solving therapy, PST, waitlist, secondary mental health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression is common and disabling but access to specialist treatment is often delayed with waiting lists of up to a year not uncommon. Also treatment is frequently limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE (The National Institute for Health and Clinical Excellence) and others about the importance of non-drug therapies. One way to address this problem is to use computerized e-therapies which deliver structured cognitive behavioral treatment where the therapy can be accessed in a location and at a time that is convenient for patients and where there is no waiting list. Previous randomized controlled trials of e-therapies for depression have mainly been in people recruited through the internet or in clinical populations with mild disorders where many participants do not complete the on-line course. Despite this there is some evidence that clinician-assisted computerized cognitive behavior therapy can result in significant improvements in depression with reduced demands on clinician time. To date there have been no trials of clinician assisted e-therapy in secondary care.
Therefore the aim of this clinical trial is to answer the question "In patients on the waiting list for the mood program does a computerized therapy with an e-therapy coach compared to written information about depression and the availability of computerized treatments result in better outcomes, quicker improvements and the use of fewer resources after 12 weeks". The study will be a randomized controlled trial with health service use and PHQ-9 as the main outcome measures.
Detailed description
Depression is common and disabling but the evidence is that fewer than half of people with depression seek any treatment and few receive any help from specialized mental health professionals (1). In secondary care treatment is often limited to drug therapies because of long waiting lists to see psychological therapists face to face despite recommendations by NICE and others about the importance of non-drug therapies (2). At The Royal Ottawa Health Care Group the waiting time to be seen in the Mood Program is between nine months and a year. One way to address this problem is to use computerized e-therapies which deliver structured cognitive behavioral treatment via a computer (3). The appeal of e-therapies is that they solve several problems. Firstly they are convenient for users. They can be used at any time and can be accessed in different locations. Secondly there is no waiting for appointments. Last for health providers they address the workforce issue of a lack of trained providers of effective interventions. If e-therapies can be shown to be acceptable, feasible and effective there is no reason why these computerized therapies could not replace humans leaving qualified professionals to focus on more complex management problems. This may lead to the development of new role which in this proposal is an e-therapy coach.
Previous randomized controlled trials of e-therapies for depression have mainly been in people recruited through the internet or in clinical populations with mild or "sub-clinical" disorders(4). The difficulty with these populations is that there is a high rate of spontaneous remission. However systematic reviews have consistently found a significant moderate effect of computerized therapies in reducing depressive symptoms compared to control conditions (5, 6). A further problem is that many people fail to complete the course of e-therapy (although this also applies to face to face therapies). There is a need for randomized controlled trials of e-therapies in clinical populations using novel techniques to maximize the dose of e-therapy without losing the potential health workforce benefits.
A potentially attractive solution is to enable clinician-assisted computerized cognitive behavior therapy. For this proposal the investigators plan to use an e-therapy coach who would coach people through the on-line therapy. In this model the clinician acts in the role of a coach to support the patient progress through the computerized treatment - the clinician does not need to deliver the non-drug therapy themselves. There is some evidence that this can result in significant improvements in depression with reduced demands on clinician time(7). However previous trials have been done using participants with relatively less severe depression who may not have seen clinicians as part of their usual care (8). Also the outcome measures are usually only self-rating scales rather than objective measures of function. To date there have been no trials of clinician assisted e-therapy in secondary care.
"The Journal" (9) a free internet based program for the self-management of depression (www.depression.org.nz) was developed in New Zealand and capitalizes on the social marketing appeal of Sir John Kirwan, an ex All Black who has described his experiences of depression to help destigmatize mental illness. However in Canada John Kirkan is unknown so one hypothesis the investigators will test in this study is whether the social marketing by a celebrity is necessary for the effective use of an e-therapy. The self-help program is based on the cognitive behavioral techniques of behavioral activation and problem solving which teaches patients the skills of problem solving and delivers an evidence based intervention which is personalized for their individual care. The problem solving approach was derived from a large randomized control trial of face to face problem solving used in people who presented to emergency departments with intentional self-harm (10).
Usage data from New Zealand shows that the depression.org web site was visited by 700,000 people in its first year (the population of New Zealand is 4.2 million) with 20,000 registered with The Journal and 13,000 active users. About 1500 people a month register to start the program with about three quarters of people recording significant improvement. Although the program was designed for depression of mild to moderate severity the evidence shows that nearly a third of people who access the program have more severe depression. The mean PHQ-9 score at the start of the program is 16 which reduces to 10 after 3 sessions and 7 by the end of the program. The change in depression scores is most marked for severe depression with only 5% of people scoring in the severe range at the end of the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In addition to their usual clinical care will also be given written information about web sites that provide information on depression but will not be specifically directed to The Journal. |
| Computerized Therapy | Experimental | Other: The JournalIn addition to their usual clinical care they will receive an invitation to use The Journal supported by an e-therapy coach who will provide patients with weekly email or telephone contact. The e-therapy coach will have a guideline script for each lesson of The Journal to reinforce the topic of each lesson, help identify and support patients in their goals and to coach them in goal setting and the techniques of problem solving. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16 years of age or older .
- Referred to the Youth, Geriatric, or Mood and Anxiety Psychiatry Programs at the Royal Ottawa Mental Health Centre for any depressive symptoms.
- Has been triaged to the Youth, Geriatric, or Mood and Anxiety Psychiatry Programs at the Royal Ottawa Mental Health Centre.
Key exclusion criteria (4 listed)
- Is unable to read or write in English
- Has cognitive impairments that render participant unable to use a computer
- Does not have access to a computer
- Does not have an OHIP number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Journal"The Journal" is a free internet based program for the self-management of depression (www.depression.org.nz) that was developed in New Zealand and capitalizes on the social marketing appeal of Sir John Kirwan, an ex All Black who has described his experiences of depression to help destigmatize mental illness. . The self-help program is based on the cognitive behavioral techniques of behavioral activation and problem solving which teaches patients the skills of problem solving and delivers an evidence based intervention which is personalized for their individual care. | Other | Computerized Therapy |
Primary outcome
Change in Scores on PHQ-9 Scale
Time frame: Baseline, 2, 6 and 12 weeks
Measures severity of depressive symptoms.
7 secondary outcomes
Change in Scores on SF-12 Scale
Time frame: Baseline, 6 and 12 weeks
Change in Scores on EQ-5D Scale
Time frame: Baseline, 6 and 12 weeks
Internet Use Questionnaire
Time frame: 12 weeks
Time Off Work Questionnaire
Time frame: 12 weeks
Hospital Admission from ICES data
Time frame: 12 weeks
Outpatient appointments from ICES data
Time frame: 12 weeks
Medication use from ICES data
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 17826154Andrews G, Titov N. Depression is very disabling. Lancet. 2007 Sep 8;370(9590):808-9. doi: 10.1016/S0140-6736(07)61393-2. No abstract available.
- Background: PubMed 20183695Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
- Background: PubMed 23587347So M, Yamaguchi S, Hashimoto S, Sado M, Furukawa TA, McCrone P. Is computerised CBT really helpful for adult depression?-A meta-analytic re-evaluation of CCBT for adult depression in terms of clinical implementation and methodological validity. BMC Psychiatry. 2013 Apr 15;13:113. doi: 10.1186/1471-244X-13-113.
- Background: PubMed 20544030Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. PLoS One. 2010 Jun 8;5(6):e10939. doi: 10.1371/journal.pone.0010939.
- Background: PubMed 21816868Hatcher S, Sharon C, Parag V, Collins N. Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):310-6. doi: 10.1192/bjp.bp.110.090126. Epub 2011 Aug 4.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 11491192Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- Background: PubMed 31886986Depression: Evidence Update April 2012: A summary of selected new evidence relevant to NICE clinical guideline 90 'The treatment and management of depression in adults' (2009) [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2012. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552056/
- BackgroundMarks I, Cavanagh K, Gega L. Hands-on help: Computer-aided psychotherapy. Psychology Press Taylor and Francis, 2007
- BackgroundCowpertwait L, Clarke D. Effectiveness of web-based psychological interventions for depression: A meta analysis. International Journal of Mental Health and Addiction. 2013; 11: 247-68
- Background: PubMed 20152960Vernmark K, Lenndin J, Bjarehed J, Carlsson M, Karlsson J, Oberg J, Carlbring P, Eriksson T, Andersson G. Internet administered guided self-help versus individualized e-mail therapy: A randomized trial of two versions of CBT for major depression. Behav Res Ther. 2010 May;48(5):368-76. doi: 10.1016/j.brat.2010.01.005. Epub 2010 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Hatcher, MD. principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Journal in people with Depression, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scores on PHQ-9 Scale (time frame: Baseline, 2, 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423733, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.