Comparison Study of Family Practice Interventions for Depression in Adults

NCT01975207 | Completed

• 1 other identifier: AMH-SCN-01
• Study Type: interventional
• Target: 1,489
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction in total health care costs

  12 weeks/12 months

Study Arms (4)

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 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.

Behavioral: Treatment as usual

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.

Behavioral: Internet Intervention

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.

Behavioral: Depression Treatment Pathway

Interventions

Treatment as usual BEHAVIORAL

Participants will be treated as per clinic's standard treatment for depression.

Group 2

Internet Intervention BEHAVIORAL

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

Also known as: Guided internet-based invtervention, Moodgym, On-line CBT

Group 3

Depression Treatment Pathway BEHAVIORAL

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.

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and above
• Cognitively capable of independently understanding and confirming their desire to take part

You may not qualify if:

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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Addiction & Mental Health Strategic Clinical Network: collaborator

Related Publications (2)

• 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. doi: 10.5694/j.1326-5377.2010.tb03690.x.

  PMID: 20528705 BACKGROUND

• Yan C, Rittenbach K, Souri S, Silverstone PH. Cost-effectiveness analysis of a randomized study of depression treatment options in primary care suggests stepped-care treatment may have economic benefits. BMC Psychiatry. 2019 Aug 5;19(1):240. doi: 10.1186/s12888-019-2223-3.

  PMID: 31382932 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Peter H Silverstone, M.D.

  Alberta Health Services and University of Alberta

  PRINCIPAL INVESTIGATOR

• Katherine Rittenbach, PhD

  Alberta Health services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 4, 2013
• Study Start: November 1, 2013
• Primary Completion: May 5, 2015
• Study Completion: May 5, 2015
• Last Updated: July 30, 2020

Record last verified: 2020-07