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

Primary Purpose

Anxiety, Depressive Symptoms, Post Traumatic Stress Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Honduras
Study Type
Interventional
Intervention
Brief cognitive behavioral therapy
Crisis intervention therapy
Sponsored by
Universidad Nacional Autonoma de Honduras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring telepsychiatry, cognitive behavioral therapy, crisis intervention, anxiety, depression, post traumatic stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Nacional Autónoma de Honduras

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brief cognitive behavioral therapy

Crisis intervention therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2020
Last Updated
June 30, 2020
Sponsor
Universidad Nacional Autonoma de Honduras
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1. Study Identification

Unique Protocol Identification Number
NCT04394455
Brief Title
Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry on Psychiatric Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Autonoma de Honduras

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depressive Symptoms, Post Traumatic Stress Symptoms, Perceived Stress
Keywords
telepsychiatry, cognitive behavioral therapy, crisis intervention, anxiety, depression, post traumatic stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
Investigators will not take part in the baseline symptom evaluation of subjects or the post-intervention evaluation.
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry.
Arm Title
Crisis intervention therapy
Arm Type
Active Comparator
Arm Description
Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry.
Intervention Type
Behavioral
Intervention Name(s)
Brief cognitive behavioral therapy
Intervention Description
9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
Intervention Type
Behavioral
Intervention Name(s)
Crisis intervention therapy
Intervention Description
3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
Primary Outcome Measure Information:
Title
Rate reduction in Depressive symptoms
Description
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.
Time Frame
6 months after psychotherapeutic intervention has started
Title
Rate reduction in Anxiety symptoms
Description
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.
Time Frame
6 months after psychotherapeutic intervention has started
Title
Rate reduction in Post traumatic Stress symptoms
Description
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.
Time Frame
6 months after psychotherapeutic intervention has started
Title
Rate reduction in Perceived stress level
Description
Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.
Time Frame
6 months after psychotherapeutic intervention has started

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José R Galindo-Donaire, MD
Organizational Affiliation
Universidad Nacional Autonoma de Honduras
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena N Reyes-Flores, MD
Organizational Affiliation
Universidad Nacional Autonoma de Honduras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Nacional Autónoma de Honduras
City
Tegucigalpa
State/Province
Francisco Morazán
ZIP/Postal Code
11101
Country
Honduras

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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