Clinical trial NCT04394455: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depressive Symptoms
Post Traumatic Stress Symptoms
Perceived Stress
Keywords: telepsychiatry
cognitive behavioral therapy
crisis intervention
anxiety
depression
post traumatic stress
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate reduction in Depressive symptoms
timeFrame: 6 months after psychotherapeutic intervention has started
measure: Rate reduction in Anxiety symptoms
timeFrame: 6 months after psychotherapeutic intervention has started
measure: Rate reduction in Post traumatic Stress symptoms
timeFrame: 6 months after psychotherapeutic intervention has started
measure: Rate reduction in Perceived stress level
timeFrame: 6 months after psychotherapeutic intervention has started
Secondary outcomes:
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Universidad Nacional Autónoma de Honduras
state: Francisco Morazán
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: José R Galindo-Donaire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional Autonoma de Honduras
name: Elena N Reyes-Flores, MD
role: PRINCIPAL_INVESTIGATOR
References: