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Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02423733
Recruitment Status : Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Simon Hatcher, University of Ottawa

Brief 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 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.


Condition or disease Intervention/treatment Phase
Depression Other: The Journal Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Computerized Therapy
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.
Other: 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.




Primary Outcome Measures :
  1. Change in Scores on PHQ-9 Scale [ Time Frame: Baseline, 2, 6 and 12 weeks ]
    Measures severity of depressive symptoms.


Secondary Outcome Measures :
  1. Change in Scores on SF-12 Scale [ Time Frame: Baseline, 6 and 12 weeks ]
    A generic measure of function and well being

  2. Change in Scores on EQ-5D Scale [ Time Frame: Baseline, 6 and 12 weeks ]
    A generic health-related quality of life index that can be related to costs

  3. Internet Use Questionnaire [ Time Frame: 12 weeks ]
    Record of internet resources used relating to health concerns assessed by self-report

  4. Time Off Work Questionnaire [ Time Frame: 12 weeks ]
    To assess cost of treatment

  5. Hospital Admission from ICES data [ Time Frame: 12 weeks ]
    To assess cost of treatment

  6. Outpatient appointments from ICES data [ Time Frame: 12 weeks ]
    To assess cost of treatment

  7. Medication use from ICES data [ Time Frame: 12 weeks ]
    To assess cost of treatment


Other Outcome Measures:
  1. Demographic Questionnaire [ Time Frame: Baseline ]
    To describe similarities and differences between the groups



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423733


Locations
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Canada, Ontario
Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4
Sponsors and Collaborators
University of Ottawa
Investigators
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Principal Investigator: Simon Hatcher, MD. University of Ottawa

Publications:
National Institute for Health and Clinical Excellence. Depression the treatment and management of depression in adults (Clinical guideline 90) http://guidance.nice.org.uk/CG90 2009
Marks 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
Ministry of Health. 2009. www.depression.org.nz.

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Responsible Party: Dr. Simon Hatcher, Vice Chair Research, Department of Psychiatry, University of Ottawa
ClinicalTrials.gov Identifier: NCT02423733     History of Changes
Other Study ID Numbers: 2014001
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Keywords provided by Dr. Simon Hatcher, University of Ottawa:
depression
dysthymia
cognitive behavioural therapy
CBT
problem-solving therapy
PST
waitlist
secondary mental health care
mental health
e-therapy
computerized therapy

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms