Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic: An Open-Label 12 - Weeks Randomized Controlled Trail
试验速览
- 阶段
- 3 期
- 入组人数
- 70
- 主要终点
- Change in Depressive symptoms measured by Patient Health Questionnaire-9
研究概览
简要总结
Background:
COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against it on 20 January, 2020. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term.
Importance and justify the study:
This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises
Hypothesis:
We hypothesize that compared to self-help email delivered therapy, the therapist guided e-Therapy is more efficacious in reducing the level of psychosocial stress among distressed individuals in Oman during COVID19.
Objective:
The aim of this study is to assess the efficacy of six weeks therapist guided e-Therapy versus Self-help e-mail delivered therapy on Psychological distress among random sample of individuals live in Oman during COVID 19 pandemic.
This study will recruit 60 participants from a list respondents to public survey who reported high levels of depression and anxiety, and randomize them to either therapist guided e-psychotherapy(intervention) or (control) self-help arms. Participants in the intervention arm will receive six sessions of therapist guided e therapy as described in the study schedule. Participants in the control arm will receive self-help psychotherapy contents similar to the intervention arm as detailed in the study schedule. Throughout the study, outcome and safety assessments will be conducted.
详细描述
COVID-19 (Corona Virus Disease 2019) is a virulent infectious disease with an incubation period ranging between 2-14 days. This highly contagious disease is caused by Sars-Cov-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The number of people infected by COVID-19 has increased exponentially since January as a result of traveling and contact with COVID-19 infected individual. Initially, the seriousness of COVID-19 was not gauged properly until World Health Organization classified it as Pandemic type infectious disease and rapidly made plans actions to fight against this disease on 20 January, 2020. Ever since then, epidemic prevention was comprehensively upgraded and marked the real beginning of universal concern, indicating widespread impacts. The uncertainty and low predictability of COVID-19 not only threaten people's physical health, but also affect people's mental health, especially in terms of emotions and cognition. As consequence of public emergency, with its economic health and social impacts, psychological repercussions among people are inevitable at the short and long term. For instance, self-isolation and self-quarantine are often an unpleasant experiences for those who should endure them. Quarantine is the separation and restriction of movement of people who have potentially been exposed to a contagious disease to ascertain if they become unwell, so reducing the risk of them infecting other. This definition differs from isolation, which is the separation of people who have been diagnosed with a contagious disease from people who are not sick; however, the two terms are often used interchangeably, especially in communication with the public. Separation from loved ones, the loss of freedom, uncertainty over about the disease situation, financial consequences of not being at work, and boredom can have significant impact on the individuals. Furthermore, shortage of supply of basic needs, inadequate information/ misinformation and stigma of being infected are major concerns during these times. A number of studies studying stigma during times of pandemic showed the participants endorsed discrimination evident by others treating them differently: avoiding them, withdrawing social invitations, treating them with fear and suspicion, and making critical comments. In the literature, depression, anxiety and post-traumatic stress disorder are known sequalae of such pandemic in the past. Surge in suicide thoughts and hopelessness have been reported amid previous public health crisis.
With above being mentioned and given the paucity of literature from this part of the world, the researchers embark on studying the psychological impact of COVID-19 among Omani public and decipher the personal and socio-demographic characteristics shaping individual's resilience and psychological wellbeing. Those with high level of psychological distress will be invited to participate in 12 weeks randomized control trial of e-Therapy. Such endeavor would inform the public and policy maker to preemptively take the necessary steps in helping people during crisis to avoid major losses secondary to psychological degeneration.
Importance and justify the study:
This study will assess the effectiveness of e therapy in treating anxiety and depression during a pandemic. This would be a novel way of providing therapy during crises
Hypothesis:
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Omanis and Non-Omanis living in Oman, Male or female aging 18-65 years, with PHQ-9 or GAD -7 total scores ≥
- •Has access to the internet and video conferencing.
- •Able to participate in the trial and adhere to the trial protocol.
- •Can provide a written informed consent to participate in the trial.
排除标准
- •Pre-existing mental disorders.
- •Diagnosis of moderate to severe intellectual disability.
- •Presence of alcohol or other substance use disorders (except for nicotine or caffeine).
- •Those who does not meet the inclusion criteria.
- •Those with suicidal or homicidal ideation at baseline.
结局指标
主要结局
Change in Depressive symptoms measured by Patient Health Questionnaire-9
时间窗: 6-12 weeks
Depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer "not at all" (scored as a 0) , "several days" (scored as a 1), "more than half the days" (scored as a 2), or "nearly every day" (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). The primary out come measure is to calculate the change in the mean scores of PHQ-9 from baseline to the end of the study between the intervention and the control.
Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7
时间窗: 6-12 WEEKS
The Generalized Anxiety Disorder 7-item scale is a 7- item self-report measure of generalized anxiety. Participants rate the frequency with which they experience anxiety-related symptoms on a scale of 0 (Not at all) to 3 (Nearly every day). Total scores range from 0-21 with higher scores indicating greater anxiety symptoms. The second primary out come measure is to calculate the change in the mean scores of GAD-7 from baseline to the end of the study between the intervention and the control.
次要结局
- Proportion of subjects with Significant Depression(6-12 weeks)
- Proportion of subjects with Significant Anxiety(6-12 weeks)
研究者
Mohammed Al Alawi
Principal Investigator
Sultan Qaboos University
