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Completed

NCT Number: NCT04959708

Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic

This project is aimed at physiotherapists and physiotherapy students who have been psychologically affected during the COVID 19 pandemic.

The objective of the approach is to generate a free intervention programme in virtual modality, from the approach of physiotherapy in mental health, which would help them to alleviate the negative effects of the pandemic, offer them coping tools and collaborate to improve their state of well-being.

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Key information

Conditions

Psychological Distress Anxiety Disorders Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cristina Bravo Navarro

Igualada, Barcelona, 08700, Spain

About this study

The intervention group will consist of the Ínsula method. Insula method will be developed twice a week for 12 weeks online form through videoconference platform. The intervention will consist of twelve individual treatments. It is a program of Physiotherapy in Mental Health, created by the physiotherapists Eugenia de León (Guatemala) and Moisés Magos (Mexico) in conjunction with the Psychiatrist Roberto Martínez Porras (Guatemala). It has a progressive design, seeking to strengthen emotional self-regulation skills, connection with others and the environment, and to guide a self - knowledge process. All these objectives are worked through body resources, like conscious movement, breathing, posture, contact, relaxation exercises, etc. The program has influence of various other disciplines such as Tai - Chi, Chi Kung, Sensorimotor Therapy, Somatic Education, Mindfulness, BBAT, among others. Likewise, its principles and progression are based on theoretical models of Neurosciences

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • they are physiotherapist with a moderate or severe psychological distress self-perceived regarding COVID-19 pandemic
  • age >18 years
  • they can manage to stand from the position of "lying", "sitting", and "standing" without assistance
  • they can have smartphone, laptop or device and internet access to follow the intervention

Exclusion criteria

  • they could not follow the intervention due to cognitive or physical health

Treatment and study plan

Insula treatment

Other

he intervention will consist of twelve individual treatments. Insula method consists of the facilitation and activation of self-regulation resources, relational regulation through breathing, movement, contact, sensory stimulation and posture

Primary outcomes

  1. Scale Body Connection

    Time frame: Baseline and up to 12 weeks and 1 year

    The scale consists of 20 items scored on a Likert scale ranging from 0 ("not at all") to 4 ("all the time"). It includes two independent factors (r=-.08). The first factor is Body Awareness, which assesses conscious attention to sensory cues that indicate the state of the body (e.g., tension, nervousness, relaxation). The second factor, bodily dissociation, measures bodily connection to or detachment from emotional experiences. The internal consistency of both factors was considered suitable on the basis of a Cronbach's α of 0.83 for BA (12 items) and 0.78 for BD (8 items)

Secondary outcomes

  1. Depression anxiety and stress scale

    Time frame: Baseline and up to 12 weeks and 1 year

    This questionnaire clearly differentiates anxiety from depression. Patients rate the frequency and severity of 21 negative emotional symptoms they have experienced during the previous week, using a scale ranging from 0 to 3. The questionnaire consists of three scales (depression, anxiety and stress) containing 7 items each. It is a questionnaire that allows a brief assessment of the three most important aspects of minor psychiatric disorders: depression, anxiety and stress

  2. Warwick-Edinburgh Mental Well-being Scale

    Time frame: Baseline and up to 12 weeks and 1 year

    It measures mental well-being in the previous two weeks. It is an ordinal scale consisting of 14 items with positive statements. Each item offers a 5-point Likert-type scale, from "Not at all" to "All the time", and an overall score is obtained by summing all items (range 14-70); higher scores indicate higher levels of mental well-being

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Registry information

Acronym: PHYSFORPHYS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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