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

NCT04394455 | Unknown

• 1 other identifier: 1503202018052020242912
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depressive Symptoms; Post Traumatic Stress Symptoms; Perceived Stress

Keywords

telepsychiatry; cognitive behavioral therapy; crisis intervention; anxiety; depression; post traumatic stress

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Brief cognitive behavioral therapy

EXPERIMENTAL

Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry.

Behavioral: Brief cognitive behavioral therapy

Crisis intervention therapy

ACTIVE COMPARATOR

Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry.

Behavioral: Crisis intervention therapy

Interventions

Brief cognitive behavioral therapy BEHAVIORAL

9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.

Brief cognitive behavioral therapy

Crisis intervention therapy BEHAVIORAL

3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.

Crisis intervention therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Universidad Nacional Autónoma de Honduras

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• José R Galindo-Donaire, MD

  Universidad Nacional Autonoma de Honduras

  PRINCIPAL INVESTIGATOR

• Elena N Reyes-Flores, MD

  Universidad Nacional Autonoma de Honduras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will not take part in the baseline symptom evaluation of subjects or the post-intervention evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident

Model Details: The interventional models are brief cognitive behavioral therapy and crisis intervention therapy through telepsychiatry. Each arm will be divided into therapy groups with a maximum of 10 participants per group. Each therapy session will be directed by a therapist and a co-therapist using a predefined structure for each intervention, with a duration of 60-90 minutes per session.

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 19, 2020
• Study Start: June 30, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)