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

NCT04378257 | Unknown Phase 3 DMC

• 1 other identifier: 12/2020
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Symptoms; Generalized Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Depressive symptoms measured by Patient Health Questionnaire-9

  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.

  6-12 weeks

• Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7

  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.

  6-12 WEEKS

Secondary Outcomes (2)

• Proportion of subjects with Significant Depression

  6-12 weeks

• Proportion of subjects with Significant Anxiety

  6-12 weeks

Study Arms (2)

Therapist Guided E-Therapy

EXPERIMENTAL

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

Self-Help Therapy

ACTIVE COMPARATOR

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

Interventions

Therapist Guided E-Therapy BEHAVIORAL

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

Therapist Guided E-Therapy

Self-Help Therapy BEHAVIORAL

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.)

Self-Help Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with suicidal or homicidal ideation at baseline.

Sponsors & Collaborators

• Sultan Qaboos University: lead
• The Research Council: collaborator
• Oman Medical Specialty Board: collaborator

Related Publications (1)

• Al-Alawi M, McCall RK, Sultan A, Al Balushi N, Al-Mahrouqi T, Al Ghailani A, Al Sabti H, Al-Maniri A, Panchatcharam SM, Al Sinawi H. Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19-Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial. JMIR Ment Health. 2021 Feb 12;8(2):e26683. doi: 10.2196/26683.

  PMID: 33512323 DERIVED

MeSH Terms

Conditions

Depression; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders

Central Study Contacts

Mohammed Al Alawi, MD

CONTACT

+14379725277; alalawim@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 7, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 20, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05