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DepressionNCT01975207

Comparison Study of Family Practice Interventions for Depression in Adults

A study testing Treatment as usual, Internet Intervention and Depression Treatment Pathway in people with Depression, run by AHS Cancer Control Alberta.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
Treatment as usual, Internet Intervention and Depression Treatment Pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,489 participants
Where
No sites listed yet
Study dates
Nov 2013to 5 May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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
Being tested
Treatment as usual, Internet Intervention, Depression Treatment Pathway
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment as usualBehavioural

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

  • Internet InterventionBehavioural

    Also called Guided internet-based invtervention, Moodgym, On-line CBT

    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 PathwayBehavioural

    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.

Study groups in NCT01975207
Study groupRoleWhat they receive
Group 1No interventionPatients 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 2ExperimentalGroup #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.
Receives: Behavioral: Treatment as usual
Group 3ExperimentalGroup #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.
Receives: Behavioral: Internet Intervention
Group 4ExperimentalDepression 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.
Receives: Behavioral: Depression Treatment Pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 weeks

Secondary outcomes (1)

  1. 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.

    Measured: 12 weeks/12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion5 May 2015
  4. Study completion5 May 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975207
Sponsor's protocol ID
AMH-SCN-01
Status last verified
Jul 2020
First submitted
29 Oct 2013
Last updated
30 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20528705

  • 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.

    PubMed 31382932

Questions about this trial

What is this clinical trial studying?

A study testing Treatment as usual, Internet Intervention and Depression Treatment Pathway in people with Depression, run by AHS Cancer Control Alberta.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in depression scores in those patients who have one of the two treatment interventions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01975207, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.

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