Psychological DistressPHYSFORPHYSNCT04959708
Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic
A study testing Insula treatment in people with Psychological Distress, run by Universitat de Lleida at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Insula treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- they could not follow the intervention due to cognitive or physical health
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Psychological Distress
- Being tested
- Insula treatment
- Keywords
- physical therapy, Covid-19, anxiety, depression, body awareness
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insula treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Insula treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and up to 12 weeks and 1 year
Secondary outcomes (2)
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
Measured: Baseline and up to 12 weeks and 1 year
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
Measured: Baseline and up to 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A clinical pilot study will be conducted with two controlled and parallel groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Bravo, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959708
- Sponsor's protocol ID
- PHYSFORPHYS
- Acronym
- PHYSFORPHYS
- Status last verified
- May 2022
- First submitted
- 7 Jul 2021
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Physical Therapy Management for Physiotherapists to Cope Psychological Distress During Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04959708
- Acronym / sponsor ID
- PHYSFORPHYS / PHYSFORPHYS
- Conditions
- Psychological Distress
- Keywords
- physical therapy, Covid-19, anxiety, depression, body awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A clinical pilot study will be conducted with two controlled and parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Insula treatmentParticipants 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. |
| Intervention group | Experimental | Other: Insula treatmentThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- they could not follow the intervention due to cognitive or physical health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insula treatmenthe 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 | Control group, Intervention group |
Primary outcome
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)
2 secondary outcomes
Depression anxiety and stress scale
Time frame: Baseline and up to 12 weeks and 1 year
Warwick-Edinburgh Mental Well-being Scale
Time frame: Baseline and up to 12 weeks and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insula treatment in people with Psychological Distress, run by Universitat de Lleida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale Body Connection (time frame: Baseline and up to 12 weeks and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.