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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Depressive Symptoms, Post Traumatic Stress Symptoms, Perceived Stress

Intervention / Treatment
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* Behavioral: Brief cognitive behavioral therapy
* Behavioral: Crisis intervention therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief cognitive behavioral therapy<br>Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry. | Behavioral: Brief cognitive behavioral therapy<br>* 9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.<br>|
| Active Comparator: Crisis intervention therapy<br>Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry. | Behavioral: Crisis intervention therapy<br>* 3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, telepsychiatry, cognitive behavioral therapy, crisis intervention, depression, post traumatic stress