JMIR Publications

ABSTRACT

Background:

Treatment-resistant depression (TRD) is the inability of a patient with major depressive disorder (MDD)to accomplish and or achieve remission after an adequate trial of antidepressant treatments. Several combinations and augmentation treatment strategies for TRD exist, including the use of repetitive transcranial magnetic stimulation (rTMS), and new therapeutic options are being introduced. Text4Support, a text message-based form of cognitive behavior therapy that allows patients with MDD to receive daily supportive text messages that seek to correct or alter negative thought patterns through positive reinforcement may be a useful augmentation treatment strategy for patients with TRD. It is however currently unknown if adding the Text4Support intervention will enhance patients with TRD’s response to rTMS treatments.

Objective:

This study aims to assess the initial comparative clinical effectiveness of rTMS with and without the Text4Support program as an innovative patient-centered intervention for the management of participants diagnosed with TRD.

Methods:

This study is a multicentered prospective, parallel-design, two-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for six weeks, observation, and a follow-up period of six months for participants in both arms of the study. In total, 200 participants diagnosed with TRD at rTMS care clinics in Edmonton, Alberta, and rTMS clinics in Halifax, Nova Scotia will be randomized to one of two treatment arms (rTMS sessions alone and rTMS sessions plus Text4Support intervention. Participants in each group will be made to complete evaluation measures at baseline, one month, three months, and six months. The primary outcome measure will be the mean change to scores on the Patient Health Questionnaire (PHQ-9). The secondary outcome measure includes the 7-item Generalized Anxiety Disorders Scale (GAD-7), the Columbia Suicide Severity Rating Scale (C-SSRS), and The World Health Organization - Five Well-Being Index (WHO-5). Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Qualitative data will be analyzed using a thematic analysis framework.

Results:

The result of the study is expected to be available 18 months from the start of the recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention treatment arm of the study will achieve superior outcomes compared with participants enrolled in the rTMS treatment alone arm.

Conclusions:

The concomitant application of the combination of these two treatment techniques rTMS plus Text4Support intervention has not been investigated previously. Therefore, we hope that this project will provide a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities. Clinical Trial: Health Ethics Research Board of the University of Alberta (Pro000122696) and the Nova Scotia Health Research Ethics Board (REB File #: 1028488). The study is registered with ClinicalTrials.gov (registration number NCT05570344;