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

Not Applicable

• Conditions: Anxiety; Depressive Symptoms; Perceived Stress; Post Traumatic Stress Symptoms
• Interventions: Behavioral: Crisis intervention therapy; Behavioral: Brief cognitive behavioral therapy

• Registration Number: NCT04394455
• Lead Sponsor: Universidad Nacional Autonoma de Honduras

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Status Verified: 2020-06
• Study Start: 2020-06-30
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crisis intervention therapy	Crisis intervention therapy	Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry.
Brief cognitive behavioral therapy	Brief cognitive behavioral therapy	Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry.

Primary Outcome Measures

Name	Time	Method
Rate reduction in Depressive symptoms	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	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	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	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.

Trial Locations

Locations (1)

Universidad Nacional Autónoma de Honduras; 🇭🇳 Tegucigalpa, Francisco Morazán, Honduras