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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04394455
• Other study ID #: 1503202018052020242912
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2020
• Source: Universidad Nacional Autonoma de Honduras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 236
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Perceived Stress
• Post Traumatic Stress Symptoms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Honduras	Universidad Nacional Autónoma de Honduras	Tegucigalpa	Francisco Morazán

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Honduras

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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