Repetitive Transcranial Magnetic Stimulation (rTMS) With and Without Internet-Delivered Cognitive Behavior Therapy (iCBT) For the Treatment of Resistant Depression (TRD): Protocol for Patient - Centered Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The Hamilton Depression Rating Scale.
研究概览
简要总结
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.
详细描述
BACKGROUND AND RATIONALE:
Major depression is a severe, disabling, and potentially lethal clinical disorder. While there are a wide variety of pharmaceutical agents available as treatments for major depression, only about half of patients respond to an initial course of antidepressant pharmacotherapy, It has been conservatively estimated that at least 15% of all patients with major depressive disorder remain refractory to any treatment intervention. While a complex relationship exists between disease chronicity and ineffective treatment, clinical evidence suggests that the greater the number of treatment failures, the less likelihood of a good treatment response to subsequent interventions. The reported results of the STAR*D study are the most vivid example of this clinical phenomenon. In that work, there was a progressive likelihood of poorer response with each successive treatment failure. For example, after the first treatment attempt, about 30% of patients remitted. By the time that a patient had experienced definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered fell below 10%. Taken together, these facts underline the clinical urgency for physicians to identify treatment resistant patients as early as possible so that alternative treatments with proven efficacies may be offered sooner. In turn, this will result in superior treatment outcomes for these treatment resistant patients.
Technology and the Internet have dramatically changed medicine. According to Statistics Canada, 83% of Canadians had Internet access in 2012, and more than 70% use the Internet daily; 62% were smartphone users. E-Mental health refers to the use of computers, Internet, and mobile devices for mental health information and care. E-Mental health applications are now widely available for information, screening, assessment and monitoring, interactive self-management, psychotherapy, and social support. Clinicians should be aware that there are benefits and potential harms to using and recommending e-Mental health applications and that few have good-quality evidence to support effectiveness. Meta-analyses and reviews of computer-based psychological treatment for the treatment of MDD, whether delivered over the Internet or as a stand-alone program, demonstrate convincing support for these treatment modalities. Internet- and computer-delivered cognitive behaviour therapy (iCBT) can also be helpful in relapse prevention.
In 2009, the Canadian Network for Mood and Anxiety Treatments (CANMAT), a not-for-profit scientific and educational organization, published a revision of evidence-based clinical guidelines for the treatment of depressive disorders. CANMAT has updated these guidelines in 2016 to reflect new evidence in the field. Neurostimulation, or neuromodulation, is an expanding area of research and clinical interest, driven in part by the increasing knowledge base on the neurocircuitry of depression. Most of these neurostimulation treatments have been studied and are used in patients with TRD who have failed to respond to standard treatments. However, there is no previous study which has examined the effect of rTMS plus iCBT in comparison to rTMS alone.
Repetitive Transcranial Magnetic Stimulation (rTMS):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Hamilton Depression Rating Scale.
时间窗: 6 months
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
次要结局
- Frequency, Intensity, and Burden of Side Effects Ratings *Edited for rTMS(6 months)
- Quick Inventory of Depressive Symptomatology Self Report-16.(6 months)
- Young Mania Rating Scale.(6 months)
- (The EuroQol-5 Dimension Assessment).(6 months)
- Columbia Suicide Severity Rating Scale.(6 months)
- Patient Rated Inventory of Side Effects.(6 months)
- World Health Organization Disability Assessment 2.0(6 months)
- Patient Satisfaction/ Community Service Experience Survey(3 months)