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

NCT ID: NCT06729580

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-10-30

Brief Summary

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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

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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.

Conditions

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Treatment Resistant Depression (TRD)

Keywords

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treatment resistant depression catastrophic thinking perceived injustice behavioural activation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioural Activation for Depression.

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

Group Type EXPERIMENTAL

Behavioural Activation

Intervention Type BEHAVIORAL

10-week standardized behavioural activation program.

Interventions

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Behavioural Activation

10-week standardized behavioural activation program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Michael Sullivan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Heather Adams, BSW

Role: STUDY_DIRECTOR

Dalhousie University

Locations

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McGill University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CRC245719

Identifier Type: -

Identifier Source: org_study_id