跳至主要内容
临床试验/NCT05785312
NCT05785312尚未招募不适用

Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study*

Khushal Khan Khattak Univeristy, Karak, Pakistan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)

研究概览

简要总结

This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.

详细描述

Depressive and Anxiety disorders have higher global prevalence. Moreover, they are leading causes of global burden of mental diseases (i.e., 24th leading cause of global Disability-adjusted Life Years). Such increase in the global prevalence of Depression and Anxiety disorders is due to the complexities of modern life. Nowadays various evidence-based psychotherapies, like e.g., EMDR therapy are available. Therapists have been using face-to-face modes for a long time, but with the expansion of Computer Technologies, online psychotherapies have been developed. The need for online psychotherapies was further increased due to Corona Virus-19 pandemic. Scientists have developed online modes of Cognitive Behavioral Therapy, Prolonged Exposure Therapy and Mindfulness Therapy, etc., but there are limited research studies on the online EMDR therapy, especially in the Asian countries. Therefore, questions arises a) Is it possible to treat Anxiety & Depressive disorders through online EMDR therapy? b) What adaptations would be required to be made in the face-to-face protocols of EMDR therapy? c) Whether the online EMDR therapy will be: i) fit and safe for use; ii) usable; iii) operable & practicable; and iv) efficient in delivering a timely treatment? The existing online programs of EMDR Therapy, e.g., VirtualEMDR have been built in the western-developed countries, hence may not be accessible to the local patients in Pakistan. Moreover, these programs might not be compatible with the requirements of patients in Pakistan. Keeping in view such facts, this study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy. For this purpose, patients will be recruited through a consecutive sampling technique, with a sample size of n=30. Data on symptomology and other technical data will be collected through standard scales. Qualitative data were analyzed by qualitative techniques, while the quantitative data were analyzed by descriptive and multivariate statistics. This study will be unique in its nature since a) an online EMDR therapy will be developed for Pakistani patients, b) this online system will be scientifically validated, c) and its efficacy will be compared with face-to-face EMDR therapy. This study will provide a base for the future researchers to design and implement online psychotherapies in Pakistan. In this way, the mental healthcare system of Pakistan could be ultimately revolutionized through the online treatment facilities.

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 (Participant)

盲法说明

single blinded

入排标准

年龄范围
18 Months 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Both male and female patients.
  • •Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients).
  • •Patients who have basic knowledge & skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR).
  • •Patients do not suffer from severe neuropsychological and cognitive impairments.
  • •Patients have not received any pharmacological therapy in the last three months.
  • •Patients have not received any other psychotherapy like Cognitive Behavioral Therapy.

排除标准

  • 未提供

研究组 & 干预措施

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Experimental

The standard Face to Face Eye Movement Desensitization & Reprocessing Therapy will be applied by a trained clinical psychologist through in person face to face sessions.

干预措施: Face to Face Eye Movement Desensitization & Reprocessing Therapy (Other)

Online Eye Movement Desensitization & Reprocessing Therapy

Active Comparator

The Online Eye Movement Desensitization & Reprocessing Therapy will be applied by a trained clinical psychologist through computer system by connecting through internet. For this purpose the online EMDR therapy application software will be installed

干预措施: Online EMDR Therapy System (Device)

结局指标

主要结局

Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)

时间窗: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)

Generalized Anxiety Disorder by Generalized Anxiety Disorder Questionnaire-IV. Score of 5.7 or above will indicate that the patient is suffering from Generalized Anxiety Disorder.

Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)

时间窗: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)

Major Depressive Disorder by Beck Depression Inventory-II. Score of 30 or above will indicate that the patient is suffering from major depressive disorder

Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)

时间窗: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)

Social Anxiety Disorder will be assed by Social Anxiety Scale. Score of 60 or above will indicate that the patient is suffering from Social Anxiety Disorder.

次要结局

  • Assessing changes in Obsessive symptoms with time (i.e., treatment course)(A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3))
  • Assessing changes in Somatic symptoms(A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3))
  • Assessing changes in Panic symptoms with time (i.e., treatment course)(A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3))

研究者

发起方
Khushal Khan Khattak Univeristy, Karak, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Anwar Khan

Dr. Anwar Khan, Director and Principal Investigator, Office of Research, Innovation and Commercialization

Khushal Khan Khattak Univeristy, Karak, Pakistan

研究点 (1)

Loading locations...

相似试验