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Effectiveness of Basic Body Awareness Therapy in Post-traumatic Stress Disorders: A Randomized Clinical Trial (BATEP)

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ClinicalTrials.gov Identifier: NCT04396314
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
Francesc Rubí Carnacea
Information provided by (Responsible Party):
Cristina Bravo, Universitat de Lleida

Brief Summary:
The aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.

Condition or disease Intervention/treatment Phase
PostTraumatic Stress Disorder Behavioral: Basic Body Awareness Therapy Behavioral: Psychological treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: The researcher will be blinded to group of participant
Primary Purpose: Treatment
Official Title: Effectiveness of Basic Body Awareness Therapy in Survivors of Covid-19, Health Workers and Women Suffering From Gender-based Violence Regarding Post-traumatic Stress Disorders: A Randomized Clinical Trial
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Basic Body Awareness Therapy
Basic Body Awareness Therapy (BBAT), a health oriented, multi-perspective and person-centred approach with a focus on the patient's resources, is a movement awareness training approach in physiotherapy, aiming to promote movement quality in daily life through self-exploration and self-experience enabling the learning of new movement habits. BBAT consists of a broad scope of movements in the following positions: lying, sitting, standing and walking. Relational movements are practiced in therapy with components such as rhythm, form, elasticity, flow, intention and voice
Behavioral: Basic Body Awareness Therapy
Basic Body Awareness Therapy (BBAT), a health oriented, multi-perspective and person-centred approach with a focus on the patient's resources. It is a movement awareness training approach in physiotherapy, aiming to promote movement quality in daily life through self-exploration and self-experience enabling the learning of new movement habits

Active Comparator: Control
The control group will be treatment for usual for PTSD. Pharmacological treatment is based in fluoxetine, paroxetine, sertraline and venlafaxine. Regarding non-pharmacological treatment the strongly recommendations are cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy
Behavioral: Psychological treatment
Cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy




Primary Outcome Measures :
  1. Change in Davidson Trauma Scale (DTS) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]

    The DTS is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom.

    The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters



Secondary Outcome Measures :
  1. Change in Beck Depression Inventory (BDI) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]
    BDI consisting of 21 items with a score range from 0 to 63, with a higher score indicating a greater degree of depression.

  2. Change in State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]
    Stai with statements scoring from 1 to 4; the whole score is from 0 to 60, with higher scores indicating a greater degree of anxiety

  3. Change in Short Form 36 (SF36) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]
    It measured quality of life, a generic tool whose scores range from 0 to 100; higher scores denote better quality of life. It contains 36 items grouped into eight subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health.

  4. Change in Visual Analogue Scale (VAS) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]
    VAS measures subjective characteristics that cannot be directly measured. The pain is measured from 0 to 10, with 0 representing "no pain" and 10 "unbearable pain".

  5. Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 1 month , 3 months and 6 months follow up ]
    Is an instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bedmate or roommate, these are not scored, nor reflected in the attached instrument.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a) survivors of COVID-19, health workers and women suffering from gender-based violence with level of post-traumatic stress disorder scale (DSM-V) moderate or severe,
  • b) age >18 years,
  • c) they could manage to stand in the position of "lying", "sitting", and "standing" without assistance

Exclusion Criteria:

  • a) they could not follow the intervention due to mental or physical health

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396314


Contacts
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Contact: David Barranco, MSc +34 649362274 david.barranco@udl.cat
Contact: Francesc Rubí-Carnacea, PhD +34 629817981 frubi@dif.udl.cat

Sponsors and Collaborators
Universitat de Lleida
Francesc Rubí Carnacea
Investigators
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Study Director: Cristina Bravo Navarro, PhD Department Nursing and Physiotherapy
Publications of Results:
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Responsible Party: Cristina Bravo, PhD, Universitat de Lleida
ClinicalTrials.gov Identifier: NCT04396314    
Other Study ID Numbers: UL-002
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cristina Bravo, Universitat de Lleida:
Basic Body Awareness Therapy
physiotherapy
anxiety
depression
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders