NCT04959708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

Same day

First QC Date

July 7, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

physical therapyCovid-19anxietydepressionbody awareness

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline and up to 12 weeks and 1 year

Secondary Outcomes (2)

  • Depression anxiety and stress scale

    Baseline and up to 12 weeks and 1 year

  • Warwick-Edinburgh Mental Well-being Scale

    Baseline and up to 12 weeks and 1 year

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Insula treatment

Intervention group

EXPERIMENTAL

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

Other: Insula treatment

Interventions

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

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Bravo Navarro

Igualada, Barcelona, 08700, Spain

Location

MeSH Terms

Conditions

COVID-19Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants and the therapist will remain unblinded, however, the rest of group researcher will be blinded during the whole study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A clinical pilot study will be conducted with two controlled and parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 13, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations