RESUMEN
BACKGROUND: Treatment-resistant depression (TRD) is the inability of a patient with major depressive disorder (MDD) to accomplish 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 behavioral therapy that allows patients with MDD to receive daily supportive text messages for correcting or altering 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 the response of patients with TRD to rTMS treatment. 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 patients diagnosed with TRD. METHODS: This study is a multicenter, prospective, parallel-design, 2-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for 6 weeks, observation, and a follow-up period of 6 months for participants in the study arms. 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 1 of 2 treatment arms (rTMS sessions alone or rTMS sessions plus Text4Support intervention). Participants in each group will be made to complete evaluation measures at baseline, and 1, 3, and 6 months. The primary outcome measure will be the mean change in the scores of the Patient Health Questionnaire-9 (PHQ-9). The secondary outcome measures will involve the scores of the 7-item Generalized Anxiety Disorders Scale (GAD-7), Columbia-Suicide Severity Rating Scale (CSSRS), and 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 the thematic analysis framework. RESULTS: The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the rTMS plus Text4Support intervention treatment arm of the study will achieve superior outcomes compared with the outcomes of participants enrolled in the rTMS alone arm. CONCLUSIONS: The application of the combination of rTMS and Text4Support has not been investigated previously. Therefore, we hope that this study will provide a concrete base of data to evaluate the practical application and efficacy of using the novel combination of these 2 treatment modalities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46830.
RESUMEN
Terrorism, though not well-defined, is a violent act that has been shown to have longstanding effects on the mental health of those who witness it. The aim of this general literature review is to explore the effect that terrorism has on posttraumatic stress disorder (PTSD), major depressive disorder (MDD) and anxiety disorders, as well as the bio-psycho-social determinants that mediate its impact. This paper describes the prevalence, risk factors, protective factors, common presentations and interventions identified for PTSD, depression and anxiety disorders occurring following terrorist attacks. We conducted a literature search in MEDLINE using a number of keywords detailed below. After applying inclusion and exclusion criteria, we kept 80 articles, which we summarized in tabular form. A majority of articles found detailed the impact of terrorism on PTSD, and took place in a Western, mainly American setting. The main factors that impacted the presentation of mental illness include gender, ethnicity, social supports, socioeconomic status, level of preparedness, level of exposure, pre-existing trauma and mental illness, and subsequent life stressors. The main intervention detailed in this article as showing evidence post-terrorism is trauma-focused cognitive-behavioural therapy. This study highlights the importance of this topic, and in particular, its implications for public health policy and practice.
RESUMEN
BACKGROUND: Major depression is a severe, disabling, and potentially lethal clinical disorder. Only about half of patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder (MDD) remain refractory to any treatment intervention. By the time that a patient has experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered is below 10%. Repetitive transcranial magnetic stimulation (rTMS) is considered a treatment option for patients with MDD who are refractory to antidepressant treatment. It is not currently known if the addition of internet-delivered cognitive-behavioral therapy (iCBT) enhances patients' responses to rTMS treatments. OBJECTIVE: This study will evaluate the initial comparative clinical effectiveness of rTMS with and without iCBT as an innovative patient-centered intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD). METHODS: This study is a prospective, two-arm randomized controlled trial. In total, 100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada, will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT. Participants 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 will be the mean change 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. RESULTS: We expect the results of the study to be available in 24 months. We hypothesize that participants enrolled in the study who receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone. CONCLUSIONS: The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT). TRIAL REGISTRATION: ClinicalTrials.gov NCT0423965; https://clinicaltrials.gov/ct2/show/NCT04239651. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18843.
