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

NCT04239651 | Completed

• 1 other identifier: Pro00094208
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Repetitive Transcranial Magnetic Stimulation; Internet-Delivered Cognitive Behavior Therapy; Treatment of Resistant Depression; Patient - Centered Randomized Controlled Pilot Trial

Outcome Measures

Primary Outcomes (1)

• The Hamilton Depression Rating Scale.

  The scale contains 17 variables. Some are defined in terms of a series of categories of increasing intensity, while others are defined by a number of equal-valued terms. The form on which ratings are recorded also includes: four :Diurnal variation, de- realization, paranoid symptoms, obsessional symptoms.score Range of its score is from 0-54. from 0-6 means no depression. 7-17: mild depression 18-24:moderate depression 24 and more: Severe depression

  6 months

Secondary Outcomes (8)

• Quick Inventory of Depressive Symptomatology Self Report-16.

  6 months

• Columbia Suicide Severity Rating Scale.

  6 months

• Young Mania Rating Scale.

  6 months

• Frequency, Intensity, and Burden of Side Effects Ratings *Edited for rTMS

  6 months

• Patient Rated Inventory of Side Effects.

  6 months

Study Arms (2)

Enrolment in rTMS sessions alone

ACTIVE COMPARATOR

All patients will be scheduled to receive 30 sessions of rTMS treatments over a six-week period as pre-determined by Alberta Health Services' Strategic Clinical Network for Addiction and Mental Health.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Enrolment in iCBT Plus rTMS

ACTIVE COMPARATOR

Patients in the rTMS plus iCBT arm of the study, would be assisted to register on the iCBT program (Moodgym) to receive unique login information. They would be assisted to participate in 12 one-hour sessions of iCBT at the clinic prior to receiving rTMS treatments. These in-clinic iCBT sessions would be scheduled in about three days intervals (ideally Tuesdays and Thursdays) so that patients receive two iCBT sessions each week. Patients would also be encouraged to continue with iCBT treatments on their own at home outside the sessions delivered in the clinic.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Other: Internet-Delivered Cognitive Behavior Therapy (iCBT)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

Enrolment in iCBT Plus rTMS; Enrolment in rTMS sessions alone

Internet-Delivered Cognitive Behavior Therapy (iCBT) OTHER

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.

Enrolment in iCBT Plus rTMS

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-60 years
• Suffering from a major depressive episode based on Diagnostic and Statistical manual (DSM) 5 criteria and having failed two or more standard antidepressant treatments during the current episode.
• Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more
• Participant may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants
• Able and willing to provide informed consent.

You may not qualify if:

• Diagnosis with the following conditions (current unless otherwise stated):
• Have a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in central nervous system, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness due to head injury.
• Any current Axis 1 psychotic disorder (including substance-induced psychosis, psychotic disorder due to a medical condition, or major depression with psychotic features), as defined by the MINI (Mini International Neuropsychiatric Interview; English Version 7.0.0 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); Copyright 1992---2014 Sheehan DV) at the screening visit.
• Any lifetime Axis 1 psychotic disorder (excluding substance-induced psychosis, or psychotic disorder due to a medical condition), or as defined by the MINI at the screening visit.
• Any current Axis II personality disorder that would interfere in the participation of the study as determined or might affect cognition and ability to meaningfully participate. In addition to mental retardation identified through medical history or in the opinion of the investigator.
• Have a current amnestic disorder, dementia, or delirium as defined by Montreal Cognitive Assessment of less than or equal to 16 or any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in cognitive behavioral therapy (CBT).
• Any illicit substance use as determined by positive toxicology screen for drugs of abuse; or alcohol and/or substance abuse or dependence within the past 3 months (90 days) as determined by the MINI at the screening visit
• Treatment histories including prior treatment with TMS.
• Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
• Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
• Presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Edmonton Mental Health Clinic

Edmonton, Alberta, T6R 3P5, Canada

Location

Related Publications (1)

• Abou El-Magd RM, Obuobi-Donkor G, Adu MK, Lachowski C, Duddumpudi S, Lawal MA, Sapara AO, Achor M, Kouzehgaran M, Hegde R, Chew C, Mach M, Daubert S, Urichuk L, Snaterse M, Surood S, Li D, Greenshaw A, Agyapong VIO. Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression: Protocol for Patient-Centered Randomized Controlled Pilot Trial. JMIR Res Protoc. 2020 Oct 27;9(10):e18843. doi: 10.2196/18843.

  PMID: 33107835 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Vincent Agyapong, MD,Ph.D

  Division of Community Psychiatry, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because it will not be possible for participants to be blinded, treatment allocation will be made explicit to them as soon as randomization is concluded. Primary outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the database which contains the randomization code. After data collection is complete, all data will undergo a blind review for the purposes of finalizing the planned analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 27, 2020
• Study Start: October 15, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)