Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Patient-centered Multicentral Randomized Controlled Pilot Trial. Protocol.
概览
- 阶段
- 不适用
- 干预措施
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- 疾病 / 适应症
- Depressive Disorder, Treatment-Resistant
- 发起方
- University of Alberta
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The Patient Health Questionnaire (PHQ-9)
- 状态
- 招募中
- 最后更新
- 19天前
概览
简要总结
This study is a multicenter prospective, parallel design, two-arm, rater-blinded randomized controlled pilot trial. Participants will be randomly assigned to one of two treatment conditions. In the first condition, treatment consists of rTMS sessions combined with Text4Support. The second condition is made up of the treatment as usual (rTMS sessions alone). The recruitment process is scheduled to last 12 months. It will involve active treatment for six weeks and follow-up period observation periods of 1,3, and 6 months for participants in both arms of the study. Participants will be recruited from four different centers for this project. Two centers (the Addiction and Mental Health clinic and the Alberta day hospital) will be from the large, sociodemographic diverse city of Edmonton in Alberta Western Canada. The remaining two centers will be in Halifax and Annapolis Valley in Nova Scotia, Canada.
详细描述
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). 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. Interventions: Study participants will be randomized to one of the treatment interventions (rTMS alone or rTMS plus Text4Support). During the introductory visit to the study sites, participants in both arms of the study will be given a detailed orientation about the rTMS application, and all procedures and activities within each visit will be explained to them. As part of their participation in the rTMS program, all patients will be made to complete some standard measures. Participants will be invited to the various rTMS clinics a week before the commencement of the rTMS sessions to enable them to undergo motor threshold (MT) assessments. The MT assessment is essential in that it aids in the selection of the required stimulation intensity for each patient for inclusion in the treatment. MT assessment is a measure of the minimum intensity of TMS output needed to elicit a motor response in the participating TRD patients in at least 50% of all attempts. The MT assessments will be conducted by the rTMS team of experts within the rTMS clinics in the various treatment centers and may consist of psychiatrists, nurses, and other healthcare professionals with the requisite knowledge to do so. Each TMS assessment session will take about 3-5 minutes, and the total time will be within 35-45 minutes. This visit timeline will be the same for all study participants. Overall, all study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health. Additionally, participants in the rTMS plus Text4Support group of the study will be assisted by a study team member assigned that purpose to register on to the Text4Support program. The process will require all participants in this arm of the study to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.
研究者
入排标准
入选标准
- •aged 18 and above and diagnosed with MDD based upon the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and who have at least failed two or more standard antidepressant treatments during the current episode. Participants may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines, and anticonvulsants. They must have a good understanding of the English language. Must have access to a smartphone and be able to receive and read text messages. Must be willing to provide written informed consent upon acceptance into the study.
排除标准
- •Patients below the age of
- •Having diagnosis such as the following conditions (current unless otherwise stated): A neurological disorder, including a history of seizures, having primary or secondary tumors in the central nervous system, cerebrovascular disease, stroke, cerebral aneurysm, movement disorder,
- •Having a current psychotic disorder such as substance-induced psychosis, psychotic disorder due to a medical condition, or MDD with psychotic features at the time of screening
- •Having a current personality disorder that may hinder the patient's participation in this research or may have the potential of affecting cognition and ability to fully participate in the study.
- •Having a learning disability as per identified through medical history or by the investigator during the assessment process.
- •Participants involved in any drug or device clinical trial within the last six weeks before the screening visit and/or involvement in another clinical trial for the duration of this study.
- •Pregnant and breastfeeding women.
- •Identification and/or the sudden appearance of any condition or instance from the mentioned above and based on the expertise of the investigators that have the potential to hinder the progress and completion and/or become a confounding factor on the outcome assessments.
研究组 & 干预措施
Enrolment in rTMS sessions alone
All study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS)
Enrolment in rTMS sessions plus Text4Support
Participants in the rTMS plus Text4Support group of the study would be assisted by a study team member assigned that purpose to register onto the Text4Support program. The process would require all participants to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) Plus Text4Support
结局指标
主要结局
The Patient Health Questionnaire (PHQ-9)
时间窗: 6 months
With 9 items, the PHQ-9 is half the length of many other depression measures, has comparable sensitivity and specificity, and it's made up of the actual 9 criteria upon which the diagnosis of depressive disorders according to the DSM-IV is based. This instrument has the potential to establish major depressive disorder diagnoses as well as grading the severity of depressive symptom
The Patient Health Questionnaire (PHQ-9)
时间窗: Baseline
With 9 items, the PHQ-9 is half the length of many other depression measures, has comparable sensitivity and specificity, and it's made up of the actual 9 criteria upon which the diagnosis of depressive disorders according to the DSM-IV is based. This instrument has the potential to establish major depressive disorder diagnoses as well as grading the severity of depressive symptom
The Patient Health Questionnaire (PHQ-9)
时间窗: 1 month
With 9 items, the PHQ-9 is half the length of many other depression measures, has comparable sensitivity and specificity, and it's made up of the actual 9 criteria upon which the diagnosis of depressive disorders according to the DSM-IV is based. This instrument has the potential to establish major depressive disorder diagnoses as well as grading the severity of depressive symptom
The Patient Health Questionnaire (PHQ-9)
时间窗: 3 months
With 9 items, the PHQ-9 is half the length of many other depression measures, has comparable sensitivity and specificity, and it's made up of the actual 9 criteria upon which the diagnosis of depressive disorders according to the DSM-IV is based. This instrument has the potential to establish major depressive disorder diagnoses as well as grading the severity of depressive symptom
次要结局
- Columbia Suicide Severity Rating Scale(6 months)
- The World Health Organization - Five Well-Being Index (WHO-5)(6 months)
- Generalized Anxiety Disorders Scale (GAD-7)(6 months)
- Generalized Anxiety Disorders Scale (GAD-7)(Baseline)
- Generalized Anxiety Disorders Scale (GAD-7)(1 month)
- Generalized Anxiety Disorders Scale (GAD-7)(3 months)
- Columbia Suicide Severity Rating Scale(Baseline)
- Columbia Suicide Severity Rating Scale(1 month)
- Columbia Suicide Severity Rating Scale(3 months)
- The World Health Organization - Five Well-Being Index (WHO-5)(Baseline)
- The World Health Organization - Five Well-Being Index (WHO-5)(1 month)
- The World Health Organization - Five Well-Being Index (WHO-5)(3 months)