Adult Depression and Integrative Medical Care

NCT06915207 | Completed

• 1 other identifier: USaskatchewan-CH&E
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

adults; Depression; Integrative medical care; quasi-experimental design

Outcome Measures

Primary Outcomes (1)

• Change in depression

  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

Study Arms (2)

Usual care for depression

NO INTERVENTION

Medication for depression

Intervention

ACTIVE COMPARATOR

Integrative medical care

Dietary Supplement: Counselling, behavioural, nutrition

Interventions

Counselling, behavioural, nutrition DIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5E5, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

Counseling; Nutritional Status

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Anne Leis, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Shirley Maltman, MD

  University of Saskatchewan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Longitudinal over 1 year

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: December 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: within 3 months

Locations

CA (1)