NCT02423733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

April 13, 2015

Last Update Submit

December 17, 2018

Conditions

Keywords

depressiondysthymiacognitive behavioural therapyCBTproblem-solving therapyPSTwaitlistsecondary mental health caremental healthe-therapycomputerized therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Scores on PHQ-9 Scale

    Measures severity of depressive symptoms.

    Baseline, 2, 6 and 12 weeks

Secondary Outcomes (7)

  • Change in Scores on SF-12 Scale

    Baseline, 6 and 12 weeks

  • Change in Scores on EQ-5D Scale

    Baseline, 6 and 12 weeks

  • Internet Use Questionnaire

    12 weeks

  • Time Off Work Questionnaire

    12 weeks

  • Hospital Admission from ICES data

    12 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Demographic Questionnaire

    Baseline

Study Arms (2)

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.

Other: The Journal

Interventions

"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.

Computerized Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

Location

Related Publications (14)

  • 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.

    PMID: 17826154BACKGROUND
  • Andersson 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.

    PMID: 20183695BACKGROUND
  • So 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.

    PMID: 23587347BACKGROUND
  • Titov 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.

    PMID: 20544030BACKGROUND
  • Hatcher 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.

    PMID: 21816868BACKGROUND
  • Ware 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.

    PMID: 1593914BACKGROUND
  • Rabin 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.

    PMID: 11491192BACKGROUND
  • Craig 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.

    PMID: 18824488BACKGROUND
  • Depression: 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/

    PMID: 31886986BACKGROUND
  • Marks I, Cavanagh K, Gega L. Hands-on help: Computer-aided psychotherapy. Psychology Press Taylor and Francis, 2007

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 20152960BACKGROUND
  • Ministry of Health. 2009. www.depression.org.nz.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionDysthymic DisorderPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersPersonal Satisfaction

Study Officials

  • Simon Hatcher, MD.

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair Research, Department of Psychiatry

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 22, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

May 31, 2019

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations