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Completed

NCT Number: NCT06729580

Risk-Targeted Behavioural Activation for 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.

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Key information

Conditions

Treatment Resistant Depression (TRD) Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University

Montreal, Quebec, H3A 1G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioural Activation

Behavioral

10-week standardized behavioural activation program.

Primary outcomes

  1. 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

  1. Catastrophic thinking

    Time frame: 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.

  2. Perceived Injustice

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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