A Multimodal Psychological Intervention for Persons with Multiple Sclerosis: Development, Feasibility, and Efficacy Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Anxiety and Depression
研究概览
简要总结
The study will be a parallel two-arm randomized, controlled trial with an intervention group and
a treatment-as-usual group, with baseline, post-treatment and 3-month follow-up assessment.
The subjects will be randomized using computer-generated random number tables with allocation
concealment.
Primary outcome measures will be assessed by an independent blinded rater at baseline, post, and
3-month follow-up points.
A sample of 44 patients with a diagnosis of MS will be recruited from NIMHANS outpatient
clinical services.
Individuals who meet inclusion criteria and give consent will be recruited for the study.
They will be assigned to the intervention or treatment as usual group using block
randomization.
The participants of both the groups will complete the baseline assessment which will
include the socio-demographic data form and the outcome measures. The outcome
measures will be administered by an independent assessor who is blinded to the groups.
The intervention group will receive the psychotherapy intervention.
The primary and secondary outcome measures will be administered post-intervention
and 3-month follow-up to both the groups by an independent blinded rater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •A clinician made diagnosis of Relapsing-Remitting Multiple Sclerosis diagnosis based on the Modified McDonald’s criteria of duration less than 5 years, or with an EDSS score less than 5 if the duration is greater than 5 years.
- •Working knowledge of English and, or Tamil.
排除标准
- •Other MS subtypes, apart from RRMS.
- •Clinically relevant cognitive deficits as evaluated by the treating neurologist and indicated by a score of less than 25 on the HMSE.
- •H/o of severe psychiatric disorders, such as psychosis, severe depression, with suicidality, or any other psychiatric disorder that prevents patient from participating in the study and/or requires clinical priority.
- •Clinically relevant physical impairments, defined as an Expanded Disability Status Scale (EDSS) score higher than 5.
结局指标
主要结局
Anxiety and Depression
时间窗: Pre-intervention, post-intervention, 3-month follow-up
次要结局
- Quality of Life, Illness Perceptions, Resilience, Self-efficacy(Pre-intervention, post-intervention, 3-month follow-up)
研究者
Sindhura Lakshmikanth
University - National Institute of Mental Health and Neurosciences