Overview

This trial is active, not recruiting.

Condition depression
Treatments treatment as usual, internet intervention, depression treatment pathway
Sponsor AHS Cancer Control Alberta
Collaborator Addiction & Mental Health Strategic Clinical Network
Start date November 2013
End date June 2016
Trial size 4500 participants
Trial identifier NCT01975207, AMH-SCN-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Patients will have information collected on their quality of life (QOL) at baseline (EuroQual 5-item measure - "EQ-5D"). Patients will be followed up at week 12 for a repeated measure of QOL and a score on the depression rating scale being used in this study (Patient Health Questionnaire-9 item version - "PHQ-9"). Individuals will also be asked on their health care access frequency (HCAF) at baseline and follow up.
(Experimental)
Group #2. Screening for depression followed by treatment as usual: Patients will complete baseline measurements of their score on the PHQ-9, self-reported HCAF and QOL (EQ-5D) score. The PHQ-9 score will be given to the clinic staff who will then follow up with treatment as usual. Patients will be followed up at week 12 for self-reported HCAF,PHQ-9 and QOL scores.
treatment as usual
Participants will be treated as per clinic's standard treatment for depression.
(Experimental)
Group #3 is Internet intervention: At baseline patients will complete QOL (EQ-5D), PHQ-9 scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered a guided internet-based intervention for the treatment of depression by the study staff. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL scores.
internet intervention Guided internet-based invtervention
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
(Experimental)
Depression Treatment Pathway: At baseline patients will complete PHQ-9, QOL (EQ-5D) scores, and self-reported HCAF. Those who score 10 or more on the PHQ-9 will be offered the specific treatment as determined by the Depression Pathway by the clinic physician. Whenever possible, this pathway will be integrated into the local clinic's electronic medical record system, for ease of administration by the clinic. Patients will be followed up at week 12 for self-reported HCAF, PHQ-9 and QOL (EQ-5D) scores.
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.

Primary Outcomes

Measure
Reduction in depression scores in those patients who have one of the two treatment interventions
time frame: 12 weeks

Secondary Outcomes

Measure
Reduction in total health care costs
time frame: 12 weeks/12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Principal investigator Peter H Silverstone, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.