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Clinical Trials/NCT06729580
NCT06729580
Completed
Not Applicable

Risk-Targeted Behavioral Activation: a Novel Approach to the Management of Treatment-Resistant Depression.

McGill University1 site in 1 country118 target enrollmentJanuary 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Treatment Resistant Depression (TRD)
Sponsor
McGill University
Enrollment
118
Locations
1
Primary Endpoint
Depression symptom severity.
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

Objective: The purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (RTBA) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (TRD). Methods: The study sample consisted of 118 individuals with TRD, who were currently absent from work and referred to an occupational rehabilitation service. The RTBA intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. The objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. Measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
October 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Sullivan

Principal investigator

McGill University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Participating in another psychotherapeutic intervention.

Outcomes

Primary Outcomes

Depression symptom severity.

Time Frame: baseline/immediately after the intervention

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.

Secondary Outcomes

  • Catastrophic thinking(baseline/immediately after the intervention.)
  • Perceived Injustice(baseline/immediately after the intervention.)

Study Sites (1)

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