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

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment Resistant Depression (TRD)
• Intervention / Treatment: Behavioral: Behavioural Activation

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1G1
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioural Activation for Depression.; All participants were enrolled in a 10-week standardized risk-targeted behavioural activation intervention.	Behavioral: Behavioural Activation; 10-week standardized behavioural activation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catastrophic thinking	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.	baseline/immediately after the intervention.
Perceived Injustice	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.	baseline/immediately after the intervention.

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Michael Sullivan, PhD, McGill University; Study Director: Heather Adams, BSW, Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: treatment resistant depression; behavioural activation; catastrophic thinking; perceived injustice
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: CRC245719

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No