StressNCT07045792
Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood
A study testing Body Awareness Therapy in people with Stress and Psychological Factors, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological Factors, Sleep
- What is being tested?
- Body Awareness Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 28 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 20 and 30 years old
- Be literate
- Score 10 or above on the stress subscale of the Depression Anxiety Stress Scale -21
- Be willing to participate in the study voluntarily
Who cannot join
- Individuals with orthopedic, neurological, rheumatological, psychiatric, mental, or any systemic chronic diseases
- Those with cardiac problems that may prevent exercise
- Those suspected of being pregnant
- Individuals with malignancy
- Individuals with active infection
- Those who do not regularly attend the treatment program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Hatay, Antakya, 31000
Yasemin Karaaslan, PhD
About this study
Official title: Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial
Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.
Read the detailed description
This study will follow a randomized controlled trial design. The study will be conducted in young adults at the Faculty of Health Sciences, Hatay Mustafa Kemal University.
Based on data reported in the literature, using stress score changes, the effect size for the group x time interaction was calculated to be approximately f=0.36 under the assumption of a repeated measures correlation of 0.50. The ANOVA: Repeated measures, within-between interaction option from the F-test family was used in the analysis. With an effect size of f=0.36, a type I error level (α=0.05), test power of 95%, a repeated measures correlation of 0.50, and a nonsphericity correction ε=1, the power analysis indicated that a total of 28 people were needed, with a minimum of 14 people in each group.
All assessments will be conducted in person by the research team. A comprehensive evaluation of the descriptive information, functional capacity, balance, sleep quality, and psychological status of the study participants is warranted.
Treatment Program Individuals in the BAT group will train 2 days per week for 8 weeks. The training will be conducted by a person who has received BAT training at levels A, B, C and D at the Swedish Institute of Body Awareness (Institutet Basal Kroppskännedom).
Those in the control group will not receive any training and will remain on the waiting list. These patients will also be assessed at baseline and after 8 weeks. In this group, BAT will be applied to the students who want to receive the training after the last measurements.
Body Awareness Therapy Exercises consist of awareness exercises in the supine, sitting, standing, and walking positions: Considering eight weeks, the training is designed to progress gradually after every two weeks. The BAT exercises are done in groups of 6 people.
The BAT program consists of 40 minutes of exercise.
- Conditions
- Stress, Psychological Factors, Sleep, Postural Balance
- Being tested
- Body Awareness Therapy
- Keywords
- Body Awareness Therapy, Stress Levels, Psychological Stress, Balance, Sleep Quality, Functional Capacity, Physical Therapy, Postural Balance
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Awareness TherapyProcedure or surgery
Individuals trained for body awareness therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention |
| Intervention Group | Experimental | Body Awareness Therapy Receives: Procedure: Body Awareness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
They will be asked to walk as fast as they can down a 30-meter straight corridor for 6 minutes.
Measured: 8 weeks
Single Leg Stance Test
The maximum time that individuals can stand on one leg with eyes open and closed will be recorded.
Measured: 8 weeks
Y Balance Test
During the test, 3 trials will be performed for each leg and the best score will be recorded (right anterior, left anterior, right posteromedial, left posteromedial, right posterolateral, left posterolateral). The maximum reach distance was recorded for each consecutive trial.
Measured: 8 weeks
Depression Anxiety Stress Scale - 21
Psychological status will be evaluated. The total score for each heading ranges from 0 to 21. Higher total scores indicate higher depression, higher anxiety, and higher stress levels.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Sleep quality will be evaluated. The 19 items measure seven subcomponents. Each question is scored between "0" and "3". The total score (0-21) is obtained by adding the seven subscores. According to the total score, those with a score of 5 and below are interpreted as having good sleep quality, and those with a score above 5 are interpreted as having poor sleep quality.
Measured: 8 weeks
Secondary outcomes (1)
International Physical Activity Questionnaire - Short Form
Physical activity will be evaluated. Individuals with less than 600 METs of physical activity per week are classified as "inactive", individuals with 600 to 3000 METs per week are classified as "minimally active", and individuals with more than 3000 METs per week are classified as "very active".
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 May 2025
- Primary completion30 Nov 2025
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Yasemin KARAASLAN, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045792
- Sponsor's protocol ID
- BFT2025-01
- Status last verified
- May 2026
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the end of the study, with the acceptance of the article, the data requested by the reader can be shared with the approval of the authors.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07045792
- Acronym / sponsor ID
- BFT2025-01
- Conditions
- Stress, Psychological Factors, Sleep, Postural Balance
- Keywords
- Body Awareness Therapy, Stress Levels, Psychological Stress, Balance, Sleep Quality, Functional Capacity, Physical Therapy, Postural Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.
Detailed description
This study will follow a randomized controlled trial design. The study will be conducted in young adults at the Faculty of Health Sciences, Hatay Mustafa Kemal University.
Based on data reported in the literature, using stress score changes, the effect size for the group x time interaction was calculated to be approximately f=0.36 under the assumption of a repeated measures correlation of 0.50. The ANOVA: Repeated measures, within-between interaction option from the F-test family was used in the analysis. With an effect size of f=0.36, a type I error level (α=0.05), test power of 95%, a repeated measures correlation of 0.50, and a nonsphericity correction ε=1, the power analysis indicated that a total of 28 people were needed, with a minimum of 14 people in each group.
All assessments will be conducted in person by the research team. A comprehensive evaluation of the descriptive information, functional capacity, balance, sleep quality, and psychological status of the study participants is warranted.
Treatment Program Individuals in the BAT group will train 2 days per week for 8 weeks. The training will be conducted by a person who has received BAT training at levels A, B, C and D at the Swedish Institute of Body Awareness (Institutet Basal Kroppskännedom).
Those in the control group will not receive any training and will remain on the waiting list. These patients will also be assessed at baseline and after 8 weeks. In this group, BAT will be applied to the students who want to receive the training after the last measurements.
Body Awareness Therapy Exercises consist of awareness exercises in the supine, sitting, standing, and walking positions: Considering eight weeks, the training is designed to progress gradually after every two weeks. The BAT exercises are done in groups of 6 people.
The BAT program consists of 40 minutes of exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention |
| Intervention Group | Experimental | Procedure: Body Awareness TherapyBody Awareness Therapy |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between 20 and 30 years old
- Be literate
- Score 10 or above on the stress subscale of the Depression Anxiety Stress Scale -21
- Be willing to participate in the study voluntarily
Key exclusion criteria (6 listed)
- Individuals with orthopedic, neurological, rheumatological, psychiatric, mental, or any systemic chronic diseases
- Those with cardiac problems that may prevent exercise
- Those suspected of being pregnant
- Individuals with malignancy
- Individuals with active infection
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 |
|---|---|---|
| Body Awareness TherapyIndividuals trained for body awareness therapy. | Procedure or surgery | Intervention Group |
Primary outcome
6-Minute Walk Test
Time frame: 8 weeks
They will be asked to walk as fast as they can down a 30-meter straight corridor for 6 minutes.
Single Leg Stance Test
Time frame: 8 weeks
The maximum time that individuals can stand on one leg with eyes open and closed will be recorded.
Y Balance Test
Time frame: 8 weeks
During the test, 3 trials will be performed for each leg and the best score will be recorded (right anterior, left anterior, right posteromedial, left posteromedial, right posterolateral, left posterolateral). The maximum reach distance was recorded for each consecutive trial.
Depression Anxiety Stress Scale - 21
Time frame: 8 weeks
Psychological status will be evaluated. The total score for each heading ranges from 0 to 21. Higher total scores indicate higher depression, higher anxiety, and higher stress levels.
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Sleep quality will be evaluated. The 19 items measure seven subcomponents. Each question is scored between "0" and "3". The total score (0-21) is obtained by adding the seven subscores. According to the total score, those with a score of 5 and below are interpreted as having good sleep quality, and those with a score above 5 are interpreted as having poor sleep quality.
1 secondary outcome
International Physical Activity Questionnaire - Short Form
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. At the end of the study, with the acceptance of the article, the data requested by the reader can be shared with the approval of the authors.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Awareness Therapy in people with Stress and Psychological Factors, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin KARAASLAN, Assoc. Prof. (0535 845 96 25, ptyasemindeveci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 1 Jul 2026.