Risk-Targeted Behavioural Activation for the Management of Treatment-Resistant Depression.

Not Applicable

Completed

• Conditions: Treatment Resistant Depression (TRD)

• Registration Number: NCT06729580
• Lead Sponsor: McGill University

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 Timeline

• Study Start: 2022-01-05
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Depression symptom severity.	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 Outcome Measures

Name	Time	Method
Catastrophic thinking	baseline/immediately after the intervention.	The Symptom Catastrophizing Scale (SCS) was used to assess catastrophic appraisals of depressive symptoms. Scores on the SCS range from 0 to 14 where higher scores reflect a higher degree of catastrophic thinking.
Perceived Injustice	baseline/immediately after the intervention.	The Injustice Experience Questionnaire - Short Form (IEQ-SF) was used to assess injustice appraisals. Scores on the IEQ-SF range from 0 to 10 where higher scores reflect a greater sense of injustice.

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada