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

Primary Purpose

Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Insula treatment
Sponsored by
Universitat de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Distress focused on measuring physical therapy, Covid-19, anxiety, depression, body awareness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cristina Bravo Navarro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Participants in the control group will have the same exposure in time as the intervention group and will be asked to maintain their lifestyle during the whole study and to refrain from starting any new regular physical activity. In case they can not maintain the same lifestyle during the study period, they will be asked to inform the researchers at any of the assessments.

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. Insula method consists of the facilitation and activation of self-regulation resources, relational regulation through breathing, movement, contact, sensory stimulation and posture

Outcomes

Primary Outcome Measures

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 α of 0.83 for BA (12 items) and 0.78 for BD (8 items)

Secondary Outcome Measures

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
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

Full Information

First Posted
July 7, 2021
Last Updated
May 17, 2022
Sponsor
Universitat de Lleida
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1. Study Identification

Unique Protocol Identification Number
NCT04959708
Brief Title
Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic
Acronym
PHYSFORPHYS
Official Title
Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat de Lleida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress
Keywords
physical therapy, Covid-19, anxiety, depression, body awareness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A clinical pilot study will be conducted with two controlled and parallel groups.
Masking
InvestigatorOutcomes Assessor
Masking Description
The participants and the therapist will remain unblinded, however, the rest of group researcher will be blinded during the whole study
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in the control group will have the same exposure in time as the intervention group and will be asked to maintain their lifestyle during the whole study and to refrain from starting any new regular physical activity. In case they can not maintain the same lifestyle during the study period, they will be asked to inform the researchers at any of the assessments.
Arm Title
Intervention group
Arm Type
Experimental
Arm 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. Insula method consists of the facilitation and activation of self-regulation resources, relational regulation through breathing, movement, contact, sensory stimulation and posture
Intervention Type
Other
Intervention Name(s)
Insula treatment
Intervention Description
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 Outcome Measure Information:
Title
Scale Body Connection
Description
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)
Time Frame
Baseline and up to 12 weeks and 1 year
Secondary Outcome Measure Information:
Title
Depression anxiety and stress scale
Description
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
Time Frame
Baseline and up to 12 weeks and 1 year
Title
Warwick-Edinburgh Mental Well-being Scale
Description
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
Time Frame
Baseline and up to 12 weeks and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cristina Bravo Navarro
City
Igualada
State/Province
Barcelona
ZIP/Postal Code
08700
Country
Spain

12. IPD Sharing Statement

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

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