Adult Depression and Integrative Medical Care

NCT ID: NCT06915207

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Longitudinal over 1 year
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual care for depression

Medication for depression

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Integrative medical care

Group Type ACTIVE_COMPARATOR

Counselling, behavioural, nutrition

Intervention Type DIETARY_SUPPLEMENT

integrative medical care delivered by one physician and referral to other health professionals as appropriate

Interventions

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Counselling, behavioural, nutrition

integrative medical care delivered by one physician and referral to other health professionals as appropriate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Anne Leis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Leis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Shirley Maltman, MD

Role: STUDY_CHAIR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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USaskatchewan-CH&E

Identifier Type: -

Identifier Source: org_study_id

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