Adult Depression and Integrative Medical Care

April 7, 2025 updated by: Anne Leis, University of Saskatchewan

Integrative Medical Care For Adult Depression: A One Year Pilot Project

The goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. The main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one year.

Participants attended five data collection visits which occurred at baseline, 3, 6, 9 and 12 months. At each visit, they completed questionnaires and had a small blood sample drawn. They were also asked to keep a diary of their symptoms and what they did between visits. They brought a calendar summary with a saliva sample at visits 2 to 5.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N5E5
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • experiencing depressive symptoms as defined by a Centre for Epidemiologic Studies-Depression (CES-D) scale score of 16 or higher as categorized by Lewinsohn et al.
  • willing to commit to five study visits over one year.

Exclusion Criteria:

  • substance abuse
  • pregnancy
  • non-depression neurological problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care for depression
Medication for depression
Active Comparator: Intervention
Integrative medical care
Dietary supplement: Counselling, behavioural, nutrition
integrative medical care delivered by one physician and referral to other health professionals as appropriate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression
Time Frame: one year
as measured by the Beck Depression Inventory (BDI) test. It has a continuous range of whole number scores from 0-63 that correspond to four categories of depression: minimal (0-13), mild (14-19), moderate (20-28) and severe (29-63)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Anne Leis, PhD, University of Saskatchewan
  • Study Chair: Shirley Maltman, MD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USaskatchewan-CH&E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This is a small pilot study

IPD Sharing Time Frame

within 3 months

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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