AnxietyNCT04394455
Brief Cognitive Behavioral Therapy Versus Crisis Intervention Therapy Through Telepsychiatry on Psychiatric Symptoms
A study testing Brief cognitive behavioral therapy and Crisis intervention therapy in people with Anxiety and Depressive Symptoms, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depressive Symptoms, Post Traumatic Stress Symptoms
- What is being tested?
- Brief cognitive behavioral therapy and Crisis intervention therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteHonduras
- Study dates
- 30 Jun 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Universidad Nacional Autónoma de Honduras
Tegucigalpa, Francisco Morazán Department, 11101
About this study
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
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.
Read the 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.
- Being tested
- Brief cognitive behavioral therapy, Crisis intervention therapy
- Keywords
- telepsychiatry, cognitive behavioral therapy, crisis intervention, anxiety, depression, post traumatic stress
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cognitive behavioral therapyBehavioural
9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
Crisis intervention therapyBehavioural
3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
| Study group | Role | What they receive |
|---|---|---|
| Brief cognitive behavioral therapy | Experimental | Medical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry. Receives: Behavioral: Brief cognitive behavioral therapy |
| Crisis intervention therapy | Active comparator | Medical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry. Receives: Behavioral: Crisis intervention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after psychotherapeutic intervention has started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hector Benjamin Valle Rodriguez, Universidad Nacional Autonoma de Honduras
- Investigators
- José R Galindo-Donaire, MD, Principal investigator, Universidad Nacional Autonoma de HondurasElena N Reyes-Flores, MD, Principal investigator, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394455
- Sponsor's protocol ID
- 1503202018052020242912
- Status last verified
- Jun 2020
- First submitted
- 3 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04394455
- Acronym / sponsor ID
- 1503202018052020242912
- Keywords
- telepsychiatry, cognitive behavioral therapy, crisis intervention, anxiety, depression, post traumatic stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief cognitive behavioral therapy | Experimental | Behavioral: Brief cognitive behavioral therapyMedical staff (medical doctors and residents) who will receive brief cognitive behavioral therapy through telepsychiatry. |
| Crisis intervention therapy | Active comparator | Behavioral: Crisis intervention therapyMedical staff (medical doctors and residents) who will receive 3 sessions of crisis intervention therapy through telepsychiatry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief cognitive behavioral therapy9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry. | Behavioural | Brief cognitive behavioral therapy |
| Crisis intervention therapy3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry. | Behavioural | Crisis intervention therapy |
Primary outcome
Rate reduction in Depressive symptoms
Time frame: 6 months after psychotherapeutic intervention has started
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
Time frame: 6 months after psychotherapeutic intervention has started
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
Time frame: 6 months after psychotherapeutic intervention has started
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
Time frame: 6 months after psychotherapeutic intervention has started
Perceived stress scale (PSS), a 10 item scale with a score range from 0 to 40. A higher score means a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Galindo-Donaire, MD principal investigator
Universidad Nacional Autonoma de Honduras
Elena N Reyes-Flores, MD principal investigator
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cognitive behavioral therapy and Crisis intervention therapy in people with Anxiety and Depressive Symptoms, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate reduction in Depressive symptoms (time frame: 6 months after psychotherapeutic intervention has started). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.