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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04959708
Other study ID # PHYSFORPHYS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date March 1, 2022

Study information

Verified date May 2022
Source Universitat de Lleida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Insula treatment
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

Locations

Country Name City State
Spain Cristina Bravo Navarro Igualada Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scale Body Connection 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 a of 0.83 for BA (12 items) and 0.78 for BD (8 items) Baseline and up to 12 weeks and 1 year
Secondary Depression anxiety and stress scale 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 Baseline and up to 12 weeks and 1 year
Secondary Warwick-Edinburgh Mental Well-being Scale 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 Baseline and up to 12 weeks and 1 year
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