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Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378257
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
The Research Council
Oman Medical Specialty Board
Information provided by (Responsible Party):
Mohammed Al Alawi, Sultan Qaboos University

Brief 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.


Condition or disease Intervention/treatment Phase
Depressive Symptoms Generalized Anxiety Behavioral: Therapist Guided E-Therapy Behavioral: Self-Help Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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 sessions will be conducted in the Arabic or English languages.

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
Behavioral: 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 link will direct the participant directly to a screen where they will be able to see and interact with the psychologist once a week. The sessions will be conducted in the Arabic or English languages.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

Active Comparator: Self-Help Therapy
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.
Behavioral: Self-Help Therapy
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.)




Primary Outcome Measures :
  1. Change in Depressive symptoms measured by Patient Health Questionnaire-9 [ Time Frame: 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.

  2. Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7 [ Time Frame: 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.



Secondary Outcome Measures :
  1. Proportion of subjects with Significant Depression [ Time Frame: 6-12 weeks ]
    Proportion of subjects with Significant Depression (Defined as PHQ-9 total score ≥ 10 ) in each arm

  2. Proportion of subjects with Significant Anxiety [ Time Frame: 6-12 weeks ]
    Proportion of subjects with Significant Anxiety (Defined as GAD-7 total score ≥ 10 ) in each arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378257


Contacts
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Contact: Mohammed Al Alawi, MD +14379725277 alalawim@squ.edu.om

Sponsors and Collaborators
Sultan Qaboos University
The Research Council
Oman Medical Specialty Board
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Responsible Party: Mohammed Al Alawi, Principal Investigator, Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT04378257    
Other Study ID Numbers: 12/2020
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms