NCT06729580

Brief Summary

Depression is the leading cause of disability worldwide. Major Depressive Disorder (MDD) is the most common diagnosis made for individuals seeking treatment for depression. Although a wide range of treatments have been developed for the treatment of MDD, a significant proportion of patients fail to respond. This study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 30, 2024

Last Update Submit

December 8, 2024

Conditions

Keywords

treatment resistant depressioncatastrophic thinkingperceived injusticebehavioural activation

Outcome Measures

Primary Outcomes (1)

  • Depression symptom severity.

    The Patient Health Questionnaire (PHQ9) was used to assess depressive symptom severity. PHQ-9 scores can range from 0 to 27 with higher scores indicating more severe depressive symptoms.

    baseline/immediately after the intervention

Secondary Outcomes (2)

  • Catastrophic thinking

    baseline/immediately after the intervention.

  • Perceived Injustice

    baseline/immediately after the intervention.

Study Arms (1)

Behavioural Activation for Depression.

EXPERIMENTAL

All participants were enrolled in a 10-week standardized risk-targeted behavioural activation intervention.

Behavioral: Behavioural Activation

Interventions

10-week standardized behavioural activation program.

Behavioural Activation for Depression.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of Major Depressive Disorder
  • The date of diagnosis of MDD preceded referral by at least 12 months
  • At least one previous prescription of an antidepressant failed to yield therapeutic response
  • Currently taking an antidepressant
  • A PHQ9 score in the moderate to severe range of depression at the time of enrolment

You may not qualify if:

  • \- Participating in another psychotherapeutic intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 1G1, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Michael Sullivan, PhD

    McGill University

    PRINCIPAL INVESTIGATOR
  • Heather Adams, BSW

    Dalhousie University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2024

First Posted

December 11, 2024

Study Start

January 5, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

December 11, 2024

Record last verified: 2024-09

Locations