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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Journal
Sponsored by
University of Ottawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring depression, dysthymia, cognitive behavioural therapy, CBT, problem-solving therapy, PST, waitlist, secondary mental health care, mental health, e-therapy, computerized therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Ottawa Mental Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Computerized Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Scores on PHQ-9 Scale
Measures severity of depressive symptoms.

Secondary Outcome Measures

Change in Scores on SF-12 Scale
A generic measure of function and well being
Change in Scores on EQ-5D Scale
A generic health-related quality of life index that can be related to costs
Internet Use Questionnaire
Record of internet resources used relating to health concerns assessed by self-report
Time Off Work Questionnaire
To assess cost of treatment
Hospital Admission from ICES data
To assess cost of treatment
Outpatient appointments from ICES data
To assess cost of treatment
Medication use from ICES data
To assess cost of treatment

Full Information

First Posted
April 13, 2015
Last Updated
December 17, 2018
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT02423733
Brief Title
Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial
Official Title
Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, dysthymia, cognitive behavioural therapy, CBT, problem-solving therapy, PST, waitlist, secondary mental health care, mental health, e-therapy, computerized therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Computerized Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The Journal
Intervention Description
"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 Measure Information:
Title
Change in Scores on PHQ-9 Scale
Description
Measures severity of depressive symptoms.
Time Frame
Baseline, 2, 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Scores on SF-12 Scale
Description
A generic measure of function and well being
Time Frame
Baseline, 6 and 12 weeks
Title
Change in Scores on EQ-5D Scale
Description
A generic health-related quality of life index that can be related to costs
Time Frame
Baseline, 6 and 12 weeks
Title
Internet Use Questionnaire
Description
Record of internet resources used relating to health concerns assessed by self-report
Time Frame
12 weeks
Title
Time Off Work Questionnaire
Description
To assess cost of treatment
Time Frame
12 weeks
Title
Hospital Admission from ICES data
Description
To assess cost of treatment
Time Frame
12 weeks
Title
Outpatient appointments from ICES data
Description
To assess cost of treatment
Time Frame
12 weeks
Title
Medication use from ICES data
Description
To assess cost of treatment
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Demographic Questionnaire
Description
To describe similarities and differences between the groups
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Hatcher, MD.
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Ottawa Mental Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada

12. IPD Sharing Statement

Citations:
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17826154
Citation
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Can E-therapies Reduce Waiting Lists in Secondary Mental Health Care? A Randomized Controlled Trial

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