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临床试验/CTRI/2024/06/068359
CTRI/2024/06/068359招募中不适用

A study on resolution of symptoms of dissociative seizures treated with adjuvant short-term psycho-dynamically oriented cognitive behavioural therapy

Institutional Ethical Commitee, Maulana Azad Medical College and Associated Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
1) Parameters of dissociative seizure like seizure frequency, seizure duration, awareness of event and semiology of seizure before treatment, during treatment sessions and one month after last session.

研究概览

简要总结

Given that patients suffering from dissociative disorder (DS) are frequently excluded from treatment studies of related disorders like PTST, DD either explicitly or implicitly, there is a need for outcome research for this population. Moreover, there is paucity of systematic study comparing efficacy of short term dynamically oriented CBT in DS patients. Given the prevalence and health care cost associated with dissociative seizure disorder (van der Kolk, 2008) especially in India rigorous research is needed so that firm conclusion can be made about the effectiveness of dissociative disorder focused treatment. The present study is an attempt to fill this void by seeing the progression of symptoms and functional abilities in the follow up patients of DS who are treated with such a short term combination of psychotherapy and pharmacotherapy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • INCLUSION CRITERIA FOR INTERVENTION GROUP
  • Age should be between 18-60years at the time of first contact.
  • Consecutive OPD and admitted patients meeting the criteria from International Classification of Disease 10 (ICD-10) for the diagnosis of conversion disorder with seizures or convulsions (F44.5, dissociative seizure) with or without co morbid diagnosis of depression (F32), adjustment disorder (F43.2) and mixed anxiety and depressive disorder (F41.2).
  • Patients developed symptoms of dissociative seizure (F44.5) in past six months and are treatment naive since then.
  • Patients should be cooperative for the assessment, intervention and formally educated up to minimum Vth grade.
  • Patents should have psychological mindedness and willing to visit hospital weekly.
  • Patient should consent for study as well as adjuvant psychological intervention in addition to conventional pharmacological management.
  • INCLUSION CRITERIA FOR CONTROL GROUP
  • Patients have developed symptoms of dissociative seizure (F44.5) in past six months and are treatment naive since then.
  • Age should be between 18-60years at the time of first contact and matched with intervention group.
  • Age, gender and education (years) should be matched with intervention group.
  • Those who are not adequately psychological minded or it is not possible to visit hospital weekly (e.g. stays far off place).
  • Patient should consent for study as well as only conventional pharmacological management.

排除标准

  • EXCLUSION CRITERIA FOR BOTH INTERVENTION AND CONTROL GROUP 1) Past history of any type of dissociative or other psychiatric disorder.
  • Patients having any hearing or vision problems.
  • Head injury, epilepsy or any structural brain lesion or organic brain syndrome (based on clinical examination and investigation reports), dementia any endocrinological illness or taking the treatment for the same.
  • Those patients failed to attend three consecutive sessions of psychological intervention or not following instructions (e.g. medication compliance can’t be assured either verbally or conformed by checking empty foils, or not doing homework for psychological intervention etc).

结局指标

主要结局

1) Parameters of dissociative seizure like seizure frequency, seizure duration, awareness of event and semiology of seizure before treatment, during treatment sessions and one month after last session.

时间窗: therapeutic sessions (10 weekly sessions ± booster 2 session) and one month (± one week) after intervention is completed.

次要结局

  • Severity of co morbid diagnosis if any [depression (F 32) to be assessed clinically as well as by Hamilton Depression Rating Scale 17, Hamilton M 1960)], adjustment disorder (43.2) [to be assessed clinically as well as by the adjustment disorder-new model 20 (ADNM-20), by Einsle et, 2010], and anxiety [to be assessed clinically as well as by Hamilton Anxiety Rating Scale (HAM-A), Hamilton M, 1959] before treatment, during treatment sessions and one month after last session.(2) Level of recent stressor in their life at those treatment points (to be assessed by The adjustment disorder-new model 20) (Einsle et, 2010).)

研究者

发起方
Institutional Ethical Commitee, Maulana Azad Medical College and Associated Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Partha Sarathi Biswa

GB Pant Institute of PG medical education and research

研究点 (1)

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