Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry on Psychiatric Symptoms

Overview

The purpose of this randomized controlled trial is to determine the effect of two behavioral interventions: brief cognitive-behavioral therapy and crisis intervention therapy through telepsychiatry, over the level of perceived stress, anxiety, depression and post-traumatic stress symptoms during the COVID-19 pandemic in medical residents and medical staff at three hospitals in two cities of Honduras.

Full Title of Study: “Effect of Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry in Medical Staff During the COVID-19 Pandemic: A Multicentric Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: November 30, 2020

Detailed Description

The psychotherapeutic interventions are going to be delivered from June to August at each participating center. Subjects will be allocated randomly in each of the two interventional arms independently by stratification in each participating center. The population for intervention will be medical staff from three different national hospitals in the frontline during the pandemic. After valid informed consent, a screening process will take place to identify symptoms as baseline evaluation using validated self-assessment tools delivered through electronic invitation. Post-intervention measurements will take place at 3 and 6 months from baseline. Intention to treat analysis and per-protocol analysis will take place. CONSORT guidelines were followed.

Interventions

  • Behavioral: Brief cognitive behavioral therapy
    • 9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
  • Behavioral: Crisis intervention therapy
    • 3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.

Arms, Groups and Cohorts

  • Experimental: Brief cognitive behavioral therapy
    • Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry.
  • Active Comparator: Crisis intervention therapy
    • Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry.

Clinical Trial Outcome Measures

Primary Measures

  • Rate reduction in Depressive symptoms
    • Time Frame: 6 months after psychotherapeutic intervention has started
    • Patient Health Questionnaire 9 scale (PHQ-9), a 9 item scale with a score range from 0 to 27. A higher score means a worse outcome.
  • Rate reduction in Anxiety symptoms
    • Time Frame: 6 months after psychotherapeutic intervention has started
    • General Anxiety Disorder 7 Scale (GAD-7), a 7 item scale with a score range from 0 to 21. A higher score means a worse outcome.
  • Rate reduction in Post traumatic Stress symptoms
    • Time Frame: 6 months after psychotherapeutic intervention has started
    • Post-traumatic Stress Scale for DSM-5 (PCL-5), a 20 item scale with a score range from 0 to 80. A higher score means a worse outcome.
  • Rate reduction in Perceived stress level
    • Time Frame: 6 months after psychotherapeutic intervention has started
    • Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.

Participating in This Clinical Trial

Inclusion Criteria

  • Medical doctors and medical residents 18 years and older, from UNAH medical school and Hospital de Occidente.
  • Medical doctors and medical residents whom during the initial screening show positive scores in Patient Health Questionnaire-2 and Generalized Anxiety Disorder scale-2
  • Access to internet and an electronic device

Exclusion Criteria

  • Medical doctors and medical residents referring a history of psychiatric disorders
  • Medical residents that belong to the Psychiatry Residency Program
  • Medical residents and medical doctors that have been diagnosed with COVID-19
  • Medical doctors and residents whom during evaluations show severe symptoms of depression, anxiety and post-traumatic stress symptoms
  • Medical doctors and residents with negative screening in Patient Health Questionnaire-2 and Generalized Anxiety Disorder Scale-2
  • Participants that do not have access to internet connection or an electronic device.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Nacional Autonoma de Honduras
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hector Benjamin Valle Rodriguez, Chief Resident – Universidad Nacional Autonoma de Honduras
  • Overall Official(s)
    • José R Galindo-Donaire, MD, Principal Investigator, Universidad Nacional Autonoma de Honduras
    • Elena N Reyes-Flores, MD, Principal Investigator, Universidad Nacional Autonoma de Honduras

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