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

NCT04378257 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-05-08

No results posted yet for this study

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

Interventions

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

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.)

Sponsors & Collaborators

  • The Research Council

    collaborator UNKNOWN
  • Oman Medical Specialty Board

    collaborator UNKNOWN
  • Sultan Qaboos University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-09-30
Completion
2020-10-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378257 on ClinicalTrials.gov