Mobile Phone Based Intervention to Protect Mental Health in Healthcare Workers at Frontline Against COVID19

NCT04393818 | Completed Phase 3

• 1 other identifier: COVID-19/06
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

Conditions

Mental Health Disorder; Depression; Posttraumatic Stress Disorder; Burnout; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Depression, anxiety and stress

  Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

  2 weeks

Secondary Outcomes (3)

• Post-traumatic stress syndrome

  2 weeks

• Insomnia

  2 weeks

• Self Efficacy

  2 weeks

Study Arms (2)

Intervention App

EXPERIMENTAL

Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep), work environment, and social support.

Behavioral: Intervention App

Control App

SHAM COMPARATOR

Participants allocated to the control App will receive access to a a fully operational mobile phone App with limited contents about management and prevention of mental health problems. Although this group will also receive psychoeducation, the content will be reduced to general, written recommendations.

Behavioral: Intervention App

Interventions

Intervention App BEHAVIORAL

Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep disorders), work environment, and social support.

Control App; Intervention App

Eligibility Criteria

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

You may qualify if:

• Healthcare workers having provided healthcare to patients with COVID19 in a healthcare centre (any setting) during the viral outbreak in Spain.
• We will include professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.).

You may not qualify if:

• We will exclude healthcare workers not able to use, or with no access, to a smartphone.

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• Universidad de las Islas Baleares: collaborator
• Hospital Miguel Servet: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Andalusian School of Public Health: collaborator
• Hospital Son Espases: collaborator

Study Sites (1)

Ignacio Ricci-Cabello

Palma de Mallorca, Balearic Islands, 07002, Spain

Location

Related Publications (2)

• Fiol-DeRoque MA, Serrano-Ripoll MJ, Jimenez R, Zamanillo-Campos R, Yanez-Juan AM, Bennasar-Veny M, Leiva A, Gervilla E, Garcia-Buades ME, Garcia-Toro M, Alonso-Coello P, Pastor-Moreno G, Ruiz-Perez I, Sitges C, Garcia-Campayo J, Llobera-Canaves J, Ricci-Cabello I. A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 18;9(5):e27039. doi: 10.2196/27039.

  PMID: 33909587 DERIVED

• Serrano-Ripoll MJ, Ricci-Cabello I, Jimenez R, Zamanillo-Campos R, Yanez-Juan AM, Bennasar-Veny M, Sitges C, Gervilla E, Leiva A, Garcia-Campayo J, Garcia-Buades ME, Garcia-Toro M, Pastor-Moreno G, Ruiz-Perez I, Alonso-Coello P, Llobera J, Fiol-deRoque MA. Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial. J Adv Nurs. 2021 Jun;77(6):2898-2907. doi: 10.1111/jan.14813. Epub 2021 Mar 6.

  PMID: 33675247 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depression; Stress Disorders, Post-Traumatic; Burnout, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Stress, Psychological

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded, as both the intervention and the control group will receive an App with information about management of mental health problems targeted at healthcare providers. The statisticians and outcome assessors (in this case the psychologists who will undertake the pre and post intervention psychological evaluations) will also be blinded. Only the PI and a research assistance will be unblinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 19, 2020
• Study Start: May 5, 2020
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-08

Locations

ES (1)