Effectiveness of Basic Body Awareness Therapy in Post-traumatic Stress Disorders: A Randomized Clinical Trial (BATEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04396314|
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : November 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|PostTraumatic Stress Disorder||Behavioral: Basic Body Awareness Therapy Behavioral: Psychological treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|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|
|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|
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
- 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
- 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.
- 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
- 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.
- 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".
- 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.
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
|Contact: David Barranco, MSc||+34 email@example.com|
|Contact: Francesc Rubí-Carnacea, PhD||+34 firstname.lastname@example.org|
|Study Director:||Cristina Bravo Navarro, PhD||Department Nursing and Physiotherapy|