Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief cognitive behavioral therapy | Experimental | Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry. |
|
| Crisis intervention therapy | Active Comparator | Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| José R Galindo-Donaire, MD | Universidad Nacional Autonoma de Honduras | Principal Investigator |
| Elena N Reyes-Flores, MD | Universidad Nacional Autonoma de Honduras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Nacional Autónoma de Honduras | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Investigators will not take part in the baseline symptom evaluation of subjects or the post-intervention evaluation.
| 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. |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided