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Clinical Trials/NCT06729580
NCT06729580CompletedNot Applicable

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

McGill University1 site in 1 country118 target enrollmentStarted: January 5, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
118
Locations
1
Primary Endpoint
Depression symptom severity.

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Behavioural Activation for Depression.

Experimental

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

Intervention: Behavioural Activation (Behavioral)

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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Sullivan

Principal investigator

McGill University

Study Sites (1)

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