Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04378257 |
| Other study ID # |
12/2020 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
October 20, 2020 |
Study information
| Verified date |
May 2020 |
| Source |
Sultan Qaboos University |
| Contact |
Mohammed Al Alawi, MD |
| Phone |
+14379725277 |
| Email |
alalawim[@]squ.edu.om |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
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 1- To identify people with depression and anxiety symptoms during
COVID-19 using GAD-7 AND PHQ-9 scales.
2- 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.
Method Design and study site In this 12-week, open-label, comparative trial, participants
will be randomized to receive either e-Therapy or self-help therapy, using a fixed
randomization schedule allocating participant between the two treatment arms in a 1:1 ratio.
This study will be conducted virtually using a secure encrypted video conference platform to
deliver the e-Therapy to participants in intervention arm across Oman.
Allocation, concealment and randomization A software randomizer will be used to generate
block randomization (block size is 6 ) in a 1:1 ratio to balance the number of the subjects
in each arm . Block randomization is a commonly used technique in clinical trial design to
reduce bias and achieve balance in the allocation of participants to treatment arms. Block
randomization works by randomizing participants within blocks such that an equal number are
assigned to each treatment. For example, given a block size of 4, there are 6 possible ways
to equally assign participants to a block.
Participants allocation sequence either in intervention or control arm will be concealed from
the study participants and the researchers before the beginning of the trial to avoid
selection bias and it will be done through centralized service at the department of
behavioural medicine. Each code will be given a sealed opaque envelope which will contain
that participant's treatment allocation, and which will only be opened by research personnel
not involved in the study or the process of data collection. All participants will have a
code number allocated to them. As the design of this trial is open label, the participant and
therapist who will conduct the therapy will be made aware of the intervention status after
randomization finish. However, the outcome assessor,the person who will receive final outcome
assessment e mails, will be blind to the participant's allocation.
Sample Size The sample size was calculated using nMaster 2.0. The Superiority hypothesis
parallel clinical trial model was adopted to calculate the required sample size in each arm
to achieve a mean effect size of Glass's Δ = 0.75, according to published literature of
Therapist guided e-Therapy. Taking the power as 80% and 5% rate of type one error, the needed
sample size will be 36 participants in each arm after considering 20% attrition rate.
Participants selection and eligibility Inclusion criteria
- All Omanis and Non-Omanis living in Oman, Male or female aging 18-65 years, with PHQ-9
or GAD -7 total scores ≥ 10
- 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. Exclusion criteria
- 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. Intervention arm: Therapist
Guided E-Therapy The participants in this group will be allocated weekly sessions with a
trained aboard certified clinical psychologist via a web-based e-therapy platform. The
psychologist will send an invitation e-link to the participant via e-mail prior to the
scheduled meeting. The link will direct the participant directly to a screen where
participants will be able to see and interact with the psychologist once a week. The
sessions will be conducted in the Arabic or English languages.
The initial sessions would focus on building rapport and the focus would primarily be on the
on-going events and experiences of the participants after the COVID-19 outbreak. Following
sessions would focus on psychological first aid based on the following interventional tools:
Cognitive Behavior Therapy (CBT)
- Acknowledging emotions and normalizing current stress
- Differentiate dysfunction versus distress (identify any debilitating thoughts/emotions
if applicable)
- Behavioral Activation Acceptance and Commitment Therapy (ACT)
- Grounding, Breathing, Acceptance of emotions, and de-fusion The final sessions would
primarily focus on gathering data through the assessments and terminating the
therapeutic relationship.
Control arm The participants in the control group will be supplied with an automatic weekly
newsletter through E-mail containing self-help information and tips to cope with distress
associated with COVID-19 in Oman. The information will mainly comprise of behavioral tips
from principles of CBT and ACT focusing on positive cognitive reinforcement, strengthening
relationships and mindfulness practice. The participants will be requested to use this
information to manage any distress that they might experience. On the sixth week, the
participants in the control group will be assessed on their mood and anxiety symptoms.
Participants will also be requested to provide information on other self-help remedies that
participants used to improve or manage their functionality (example, access to other
websites, communication with close friends or family etc.)
Outcome Measures The Patient Healthcare Questionnaire (PHQ-9) is a self-administered measure
used to make a tentative diagnosis of depression and monitor its severity. The PHQ-9 has been
validated in a number of studies from different population ; ; . In Oman, Al-Ghafri et al
examined the applicability of PHQ-9 among medical doctors. The cut-off score of 10 gave the
best trade-off between a sensitivity of 80.6% and a specificity of 94.0%. In this study, cut
off 10 was used to indicate the presence of significant depression S within the following
classification.
The Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of a self-report questionnaire
that allows for the rapid detection of GAD . Participants are asked if they were bothered by
anxiety related problems over the past two weeks by answering seven items on a 4-point scale.
The total scores ranged from 0 to 21. At a cutoff score of 9, the GAD-7 had a sensitivity of
89 % and a specificity of 82 % for detecting GAD compared with a structured psychiatric
interview. However, the validation of Arabic version of GAD-7 indicated that a cutoff score
of 10 had the best trade-off between sensitivity and specificity. , Therefore, in the current
study researchers take a total score of 10 and above as the cut-off for significant anxiety.
GAD-7 and PHQ-9 are available to healthcare providers completely free of charge. Pfizer Inc.,
the legal copyright holder, explicitly states that "no permission [is] required to reproduce,
translate, display or distribute.
Data related to Age, gender, Martial status, Number of children, region in Oman, looking
after elderly or sick person, highest qualification, , studying abroad, Doctor ( yes , no ),
if yes specify what specialty , Nurse, Yes or No , if yes specify what area of practice, are
you working in health care? Yes or No, if yes specify your type of work, employed ( Yes, No)
if yes specify type of employment, financial strains yes or no , physical health problems yes
or no , specify if yes, mental health problems yes or no , if yes specify, self-isolation Yes
or No, self-quarantine Yes or No, coping strategies specify, e-mail address will be collected
Primary endpoint -Change in the mean scores of PHQ-9 and GAD-7 from baseline to the end of
the study between the intervention and the control.
-Secondary endpoint - Proportion of subjects with Significant Psycho-Social distress (PHQ-9
total score ≥ 10 or GAD-7 total score ≥ 10) between the two arms
Recruitment, recruitment period and consent procedure The recruitment will be taking place
over a period of 2 weeks from May 1st till May 14, 2020. Participants will be recruited
randomly from list of online survey respondents with significant psychological distress in
Oman. This survey was conducted by the current trial team during first two weeks of April
2020 and included 1539 respondents from different regions Oman. The prevalence of
psychological distress among the trial sample was 30%. The research assistant will contact
eligible participant by email and if they are interested and they will be briefed about the
trial protocol. All interaction with the subjects including explanation and consenting will
be carried out in private tele/video interview. Potential participant will receive a thorough
explanation of the objectives, procedures and risks of this protocol of this trial that is
appropriate to their level of understanding and comprehension .Based on the autonomy
principal ,it is the full right of the subject to decline to participate or to withdraw from
the study at any time without prejudice. After the consent form is explained to the
participant and all questions have been answered, the participant can discuss their
participation with the family members. After the consent is read and discussed with family,
the participant will sign an electronic informed consent, the investigator with remind the
patient that their contribution is fully voluntarily, and they can withdraw at any time.
Follow up visits and assessment procedures and Data management After baseline assessment and
receiving 6 sessions of Therapist guided e-Therapy or Self-Help therapy, participant will be
assessed for outcome measures at Week 6 and Week 12 by the sending then email link containing
GAD-7 and PHQ-9. Otherwise, Over the first 6 weeks, each visit will include, checking the
Consent, compliance with protocol and if any adverse effects. Data of each participant will
receive a unique cod (serial number) .All data will be entered initially in to specified file
for each subjects in every visit and then it will be transferred to Epi data sheet at the end
of the visits.
