CClinicalTrials.gg
CompletedNCT06729580Updated Dec 11, 2024

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

An interventional study of Behavioural Activation in Treatment Resistant Depression (TRD), sponsored by McGill University. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by McGill University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jan 2022, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Treatment Resistant Depression (TRD)

Keywords

  • treatment resistant depression
  • catastrophic thinking
  • perceived injustice
  • behavioural activation
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In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 118 is above the median of 84 across 6,722 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Participating in another psychotherapeutic intervention.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Behavioural Activation for Depression.

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

    Behavioral: Behavioural Activation

Interventions

  • BehavioralBehavioural Activation

    10-week standardized behavioural activation program.

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What researchers measure

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.

    Time frame: baseline/immediately after the intervention

Secondary outcomes

  1. 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.

    Time frame: baseline/immediately after the intervention.

  2. 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.

    Time frame: baseline/immediately after the intervention.

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Study locations

1 site
  • McGill University
    Montreal, Quebec H3A 1G1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06729580
Lead sponsor
McGill University
Responsible party
Michael Sullivan (Principal investigator, McGill University) — Principal investigator
First posted
Dec 11, 2024
Start date
Jan 5, 2022
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023
Last update
Dec 11, 2024

Study contacts

Michael Sullivan, PhD
principal investigator · McGill University
Heather Adams, BSW
study director · Dalhousie University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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