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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Depressive Symptoms; Perceived Stress; Post Traumatic Stress Symptoms
• Intervention / Treatment: Behavioral: Brief cognitive behavioral therapy; Behavioral: Crisis intervention therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Honduras
  • Francisco Morazán
    • Tegucigalpa, Francisco Morazán, Honduras, 11101
      • Universidad Nacional Autonoma de Honduras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief cognitive behavioral therapy; Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry.	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.
Active Comparator: Crisis intervention therapy; Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate reduction in Depressive symptoms	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.	6 months after psychotherapeutic intervention has started
Rate reduction in Anxiety symptoms	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.	6 months after psychotherapeutic intervention has started
Rate reduction in Post traumatic Stress symptoms	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.	6 months after psychotherapeutic intervention has started
Rate reduction in Perceived stress level	Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.	6 months after psychotherapeutic intervention has started

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras
• Investigators: Principal Investigator: José R Galindo-Donaire, MD, Universidad Nacional Autonoma de Honduras; Principal Investigator: Elena N Reyes-Flores, MD, Universidad Nacional Autonoma de Honduras

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: depression; anxiety; cognitive behavioral therapy; post traumatic stress; telepsychiatry; crisis intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 1503202018052020242912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No