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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975207
Other study ID # AMH-SCN-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date May 5, 2015

Study information

Verified date July 2020
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if treatment of significant depressive symptoms identified in individuals attending a family practice improves either psychiatric outcome, overall health care costs, or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based approach and a comprehensive depression pathway - will be compared to two control groups (those who have treatment as usual after screening for depression and measurement of QOL, and a second control group who will have QOL data only collected). The investigators hope to help Alberta Health Services identify which approach is best as rapidly as possible so that the best approach can be implemented throughout the province of Alberta.


Recruitment information / eligibility

Status Completed
Enrollment 1489
Est. completion date May 5, 2015
Est. primary completion date May 5, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults aged 18 and above

- Cognitively capable of independently understanding and confirming their desire to take part

Exclusion Criteria:

- 18 and under

- Cognitively incapable of independently understanding and confirming their desire to take part

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Treatment as usual
Participants will be treated as per clinic's standard treatment for depression.
Internet Intervention
One of the major treatments for mild-moderate depressive disorders is cognitive behavioural therapy (CBT). It has been possible to operationalize some of this treatment and internet-based approaches to this have been developed. The most widely examined was developed in Australia and is termed "MoodGYM" (https://moodgym.anu.edu.au/welcome). This program has been widely studied, and these studies have shown it is very effective for many individuals in family practice
Depression Treatment Pathway
There has been a growing awareness in health care circles that certain high frequency, high cost addiction and mental health disorders may be best addressed via the systemic adoption of clinical pathways. A clinical pathway is defined as "a multidisciplinary outline of anticipated care, placed in an appropriate timeframe, to help a patient with a specific condition or set of symptoms move progressively through a clinical experience to positive outcomes." A clinical pathway incorporates guidelines, protocols and evidence informed best practice into everyday use for the patient and family.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
AHS Cancer Control Alberta Addiction & Mental Health Strategic Clinical Network

References & Publications (1)

Hickie IB, Davenport TA, Luscombe GM, Moore M, Griffiths KM, Christensen H. Practitioner-supported delivery of internet-based cognitive behaviour therapy: evaluation of the feasibility of conducting a cluster randomised trial. Med J Aust. 2010 Jun 7;192(S11):S31-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in depression scores in those patients who have one of the two treatment interventions We expect a reduction in depression scores in those patients who have one of the two treatment interventions (Groups #3 and #4) over a 12-week period, compared to those who are screened for depression, but only receive treatment as usual (Group #2). 12 weeks
Secondary Reduction in total health care costs We expect a reduction in total health care costs in the two treatment groups compared both to those who are not screened for depression (Group #1) and those who are screened for depression, but only receive treatment as usual (Group #2). This will be a within-subject comparison for total health care costs in the 12-weeks prior to the index visit compared to the total health care costs in the 12-weeks following the index visit. Mid-term costs will also be compared between groups for the 12-month period following the index visit. Examples of costs included are the number of doctors visits, any ambulance rides or emergency room visits and lab tests. The data collected will not include any diagnosis or results and will only be used for economic analysis. This data will be owned by the University of Alberta, will not be saved in medical records and no one but the study staff will have access to the data unless authorized by a governement agency or ethics board. 12 weeks/12 months
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