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

NCT ID: NCT04394455

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-12-30

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.

Conditions

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Anxiety Depressive Symptoms Post Traumatic Stress Symptoms Perceived Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Investigators will not take part in the baseline symptom evaluation of subjects or the post-intervention evaluation.

Study Groups

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Brief cognitive behavioral therapy

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

Group Type EXPERIMENTAL

Brief cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

Crisis intervention therapy

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

Group Type ACTIVE_COMPARATOR

Crisis intervention therapy

Intervention Type 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.

Interventions

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Brief cognitive behavioral therapy

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional Autonoma de Honduras

OTHER

Sponsor Role lead

Responsible Party

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Hector Benjamin Valle Rodriguez

Chief Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José R Galindo-Donaire, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Autonoma de Honduras

Elena N Reyes-Flores, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Autonoma de Honduras

Locations

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Universidad Nacional Autónoma de Honduras

Tegucigalpa, Francisco Morazán Department, Honduras

Site Status

Countries

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Honduras

Other Identifiers

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1503202018052020242912

Identifier Type: -

Identifier Source: org_study_id

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