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Clinical Trials/NCT01975207
NCT01975207CompletedNot Applicable

Comparison Study of Family Practice Interventions for Depression in Adults

AHS Cancer Control Alberta0 sites1,489 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,489
Primary Endpoint
Reduction in depression scores in those patients who have one of the two treatment interventions

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Group 1

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.

Group 3

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.

Intervention: Internet Intervention (Behavioral)

Group 4

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.

Intervention: Depression Treatment Pathway (Behavioral)

Group 2

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.

Intervention: Treatment as usual (Behavioral)

Outcomes

Primary Outcomes

Reduction in depression scores in those patients who have one of the two treatment interventions

Time Frame: 12 weeks

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).

Secondary Outcomes

  • Reduction in total health care costs(12 weeks/12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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