NCT04078282

Brief Summary

The first part of this study aims to identify the occurence of depression in the elderly. In the second part, older patients with depression will be invited to a collaborative care with his or her family physician and a psychiatrist specialized in psychiatry in the elderly in accordance with a study protocol. The intervention includes two sessions where the patient will meet the psychiatrist together with the family physician, and between the two sessions the patient will have three treatment sessions with the family physician based on the evaluation by the psychiatrist. Following the last session with the psychiatrist the intervention ends with three more treatment sessions with the family physician.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

August 27, 2019

Last Update Submit

February 20, 2024

Conditions

Keywords

DepressionElderlyFamily Practice

Outcome Measures

Primary Outcomes (1)

  • Number of patients with a change in clinical significant depression

    Change in depression as described by the Patient Health Questionnaire (PHQ-9). The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant.

    At start and at 12 and 18 month following treatment

Secondary Outcomes (2)

  • Number of patients with a change in the level of anxiety

    At start and at 12 and 18 month following treatment

  • Number of Subjective Health Complaints among patients with depression

    At start and at 12 and 18 month following treatment

Study Arms (2)

Active treatment group

EXPERIMENTAL

Patients will meet in a joint consultation with their family physician and a psychiatrist for evaluation. Then it follows three treatment sessions with the family physician before a new joint consultation with the psychiatrist. The intervention ends with three more treatment sessions with the family physician.

Behavioral: Intervention group

Control group

ACTIVE COMPARATOR

Patients belonging to family physicians who constitute the control group will be assessed and given treatment according to usual care. This may include treatment by the family physician, medication, referrals to specialized care.

Behavioral: Intervention group

Interventions

see above

Active treatment groupControl group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • all patients visiting one of the collaborative family physicians during the enrollment period of four weeks

You may not qualify if:

  • cognitive dysfunction
  • speaking Norwegian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (1)

  • Kvalbein-Olsen LC, Aakhus E, Haavet OR, Mdala I, Werner EL. Joint consultations in a structured GP-patient-geriatric-psychiatrist model for late-life depression: a cluster RCT. BMC Prim Care. 2025 Sep 29;26(1):297. doi: 10.1186/s12875-025-03002-w.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jørund Straand, PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cluster randomized controlled trial where family physicians are to be randomized into interventional or control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 6, 2019

Study Start

September 15, 2019

Primary Completion

September 30, 2022

Study Completion

December 30, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations