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rTMS With and Without iCBT For the Treatment of Resistant Depression (TRD)

NCT04239651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-08-02

No results posted yet for this study

Summary

This is a prospective, two-arm randomized controlled trial. 100 patients diagnosed with resistant depression in psychiatric care clinic in Edmonton, Alberta, Canada will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone (2) enrolment in the rTMS sessions plus iCBT. Patients in each group will complete evaluation measures (eg, recovery, general symptomatology and functional outcomes) at baseline, 1 month, 3 months and 6 months. The primary outcome measure would be changes to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures and correlational analyses.

Conditions

  • Depressive Disorder, Treatment-Resistant

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

rTMS uses powerful (1.0-2.5 Tesla), focused magnetic field pulses to induce electrical currents in neural tissue noninvasively, via an inductor coil placed against the scalp.

OTHER

Internet-Delivered Cognitive Behavior Therapy (iCBT)

Cognitive behavioral therapy (CBT) is an evidence-based, structured, intensive, time-limited, symptom-focused form of psychotherapy recommended for the treatment of major depression and anxiety disorders. Internet-delivered CBT (iCBT) is structured CBT delivered via the internet.

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Vincent Agyapong, MD,Ph.D · Division of Community Psychiatry, University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-07-29
Completion
2022-07-29

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239651 on ClinicalTrials.gov