Online Multi-component Psychological Intervention for Healthcare Workers During COVID-19 Pandemic

NCT04890665 | Unknown DMC

• 1 other identifier: VIU-Health_care_workers_COVID
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to carry out a randomized clinical trial with healthcare workers in Mexico through a web platform. The intervention aims to reduce anxiety, depressive symptoms, burnout, stress, compassion fatigue, and increase the quality of life and sleep and self-care, as well as improve skills in providing bad news to patients and their families. A self-applied intervention will be compared with an intervention delivered by therapists providing the same intervention implemented through Zoom, Skype, or Microsoft Teams, to ensure sanitary protection measures.

Conditions

Anxiety; Depression; Sleep Disturbance; Quality of Life; Burnout, Professional; Stress; Fatigue, Compassion

Outcome Measures

Primary Outcomes (6)

• The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)

  The CESD-R is an updated version of the CES-D. The CESD-R consists of 20. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where \^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P \< 0.05) in depression symptoms.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Decrease in the symptoms of General Anxiety Disorder (GAD-7)

  On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 represent mild, moderate, and severe anxiety symptom levels, respectively. Is expected a statistically significant decrease (P \< 0.05) in the General Anxiety symptoms.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Decrease in the score of The Pittsburgh Sleep Quality Index (PSQI).

  This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistically significant decrease (P \< 0.05) in the Sleep Quality measure.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (PSS)

  The Post-Traumatic Stress Disorder Symptom Scale is a 17-item structured interview. The severity over the last 2 weeks of each item on the PSS is rated by the interviewer using a 4-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, and 3 = very much. The maximum possible score is 51 (severely affected) and the minimum possible score is 0 (total absence of the symptoms). The total severity score is calculated as the sum of the severity ratings for the 17 items. The diagnosis of the Post-Traumatic Stress Disorder Symptom Scale is made when at least 1 re-experiencing, 3 avoidance, and 2 arousal symptoms are endorsed on the scale by individuals who were traumatized at least one month prior to the assessment. It is expected a statistically significant decrease (P \< 0.05) in the symptoms of Post-Traumatic Stress Disorder in the patients suffering from this disorder.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Increase in the score of the Professional Quality of Life Measure (ProQOL)

  The professional quality of life will be evaluated with the ProQOL scale (Professional Quality of Life Measure). This scale measures the sections of Satisfaction by empathy, compassion fatigue, and Burnout. The scale is composed of 30 Likert-type questions with five possible answers, being: Never = 1, Rarely = 2, Sometimes = 3, Often = 4 and Often = 5. A score of 17 could indicate affect action in the measured dimensions. It is expected a statistically significant decrease (P \< 0.05) in the perception of Professional Quality of Life of the patients.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Increase in the score of the Appraisal of Self-care Agency (ASA)

  This scale is made up of 24 Likert-type reagents with four types of response, which have a score of one to four points, which when performing the final sum may result in the range of 24-96. The higher the resulting score, the greater the person's self-care capabilities. Maximum ability of self-care is reflected with a score of 96 and a minimum with 24, where high scores of self-care are with scores equal or higher to 76, for a medium ability with equal or higher to 70 but equal or lower than 75 and a low ability any score of 69 or lower. It is expected a statistically significant increase (P \< 0.05) in the in the score of the Appraisal of Self-care Agency.

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

Secondary Outcomes (2)

• Decrease in the Plutchik Suicide Risk Scale (BSI)

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

• Increase in the Scale for measuring resilience with Mexicans (RESI-M)

  Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 9 nuclear modules.

Study Arms (2)

Experimental: Self-applied psychological intervention for healthcare workers

EXPERIMENTAL

Participants in this group will receive 9 sessions of a multi-component psychological intervention focused on the reduction of symptoms of anxiety, depression, stress, burnout, fatigue compassion, and post-traumatic stress, and the increase of the quality of sleep and perception of the quality of life. The participants will have the option to do 3 extra modules that are complimentary for the intervention.

Behavioral: Online psychological intervention for healthcare workers

Control: Self-applied psychological intervention for healthcare workers

ACTIVE COMPARATOR

The participants in this group will receive exactly the same intervention but delivered through a therapist in a weekly session through an online video call. The participants will be informed also about the 3 extra modules and briefly what it is the contents of these modules so they can accept or not receive these extra contents.

Behavioral: Online psychological intervention for healthcare workers

Interventions

Online psychological intervention for healthcare workers BEHAVIORAL

The intervention is based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, Acceptance and Commitment Therapy and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of anxiety, depression, burnout, fatigue compassion, posttraumatic stress disorder, and affectations in sleep quality and perception of life quality in healthcare workers. And 3 complementary modules that according to the scientific literature could affect the mental health of healthcare workers related to how to deliver bad health news, Psychological first aid and how beliefs could influence physical and emotional self-care in the face of the COVID-19 pandemic.

Control: Self-applied psychological intervention for healthcare workers; Experimental: Self-applied psychological intervention for healthcare workers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have access to a communication device with access to the internet (computer, tablet, and mobile)
• To have a valid email address.
• To have basic digital skills in the use of an operational system and internet browsing.
• To understand Spanish since all the contents are in this language.
• Symptoms of anxiety, depression, burnout, and fatigue compassion

You may not qualify if:

• To have a diagnosis of psychotic disorder
• To be receiving psychological and/or pharmacological treatment during the study
• Moderate to a high score on the suicide scale
• Recent attempt of suicide (3 months)
• To refuse to accept to participate

Sponsors & Collaborators

• Universidad Internacional de Valencia: lead
• Universidad Autonoma de Ciudad Juarez: collaborator
• University of Guadalajara: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator
• Universidad Internacional del Ecuador: collaborator
• University of Buenos Aires: collaborator
• University of Valencia: collaborator

Study Sites (3)

Universidad Autónoma de Ciudad Juárez

Juárez, Chihuahua, 32315, Mexico

RECRUITING

Universidad de Guadalajara

Guadalajara, Jalisco, 44160, Mexico

NOT YET RECRUITING

Universidad Nacional Autónoma de México

México, 54090, Mexico

NOT YET RECRUITING

Related Publications (22)

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  RESULT

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  RESULT

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  PMID: 36232049 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Parasomnias; Burnout, Professional; Compassion Fatigue

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Anabel de la Rosa Gómez, PhD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Paulina Erika Herdoiza Arroyo, PhD

  Universidad Internacional del Ecuador

  STUDY CHAIR

• Rosa Olimpia Castellanos Vargas, MD

  Universidad Autonoma de Ciudad Juarez

  STUDY CHAIR

• Joaquín Mateu Molla, PhD

  Valencian International University

  STUDY CHAIR

• Luis Farfallini, PhD

  University of Buenos Aires

  STUDY CHAIR

• Eduardo Bautista Valerio, BD

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

Central Study Contacts

Alejandro Dominguez Rodriguez, PhD

CONTACT

+521 664 471 3277; alejandro.dominguez.r@campusviu.es

Reyna Jazmin Martinez Arriaga, PhD

CONTACT

+52 1 33 1197 9082; reyna.martinez@academicos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are not aware that there is an experimental group and a control group, the participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has two arms, one is the experimental group that receives the treatment solely through the online platform, and the other is the comparison group that will receive treatment delivered through a therapist through video calls. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: July 16, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This data will be available approximately in June 2022 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Locations

ME (3)