Substance Use Disorder (SUD)NCT07909447
Effects of Qigong Exercise on Anxiety and Depression in Patients Receiving Inpatient Treatment for Substance Use Disorder
A study testing Qigong Exercises in people with Substance Use Disorder (SUD) and Anxiety, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD), Anxiety, Depression
- What is being tested?
- Qigong Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being able to read and write and having no communication barriers.
- Receiving inpatient treatment for substance use disorder in a psychiatric unit.
- Having no comorbid psychiatric disorder other than substance use disorder.
- Having no diagnosis of an anxiety disorder or depression.
- Being 18 years of age or older.
- Having a State-Trait Anxiety Inventory (STAI) score of 20-59 (mild to moderate anxiety) and a Beck Depression Inventory (BDI) score of 24-48.
- Having completed the initial seven-day detoxification treatment.
Who cannot join
- Being unable to read and write and having communication difficulties.
- Having acute psychotic symptoms.
- Having a comorbid psychiatric disorder other than substance use disorder.
- Having a diagnosis of an anxiety disorder or depression.
- Receiving treatment for a condition other than substance use disorder.
- Being in the first seven days of detoxification treatment.
- Having a State-Trait Anxiety Inventory (STAI) score below 20 or above 59, or a Beck Depression Inventory (BDI) score below 24 or above 48 (minimal or severe anxiety or depression).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Psychiatric Hospital
Istanbul, Istanbul, 34768
About this study
Official title: The Effect of Qigong Exercise on Anxiety and Depression Levels in Patients Receiving Treatment for Substance Use Disorder: A Randomized Controlled Study
Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. The study was conducted as a single-blind, randomized controlled trial. Patients meeting the predefined eligibility criteria were randomly assigned to either the intervention group or the control group. The intervention group participated in Shibashi Qigong exercises four times a week for three weeks (12 sessions in total), while the control group did not receive Qigong exercises. Both groups continued their usual treatments. Anxiety and depression levels were assessed using the State-Trait Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI) at three time points: before the intervention, immediately after the three-week exercise program, and one week after its completion.
- Conditions
- Substance Use Disorder (SUD), Anxiety, Depression
- Being tested
- Qigong Exercises
- Keywords
- Qigong, Shibashi Qigong, Substance Use Disorders, Anxiety, Depression
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong ExercisesBehavioural
The intervention consisted of a standardized Shibashi Qigong exercise program delivered in 40-minute group sessions, four times per week for three weeks, for a total of 12 sessions. Each session began with a 5-minute warm-up and 5 minutes of breathing exercises, followed by 10 minutes of relaxation movements. The next 10 minutes included free spinal movements, clockwise and counterclockwise horizontal rotations, side-to-side swaying, and simple spinal exercises. Each session concluded with 10 minutes of cool-down and progressive relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Qigong Group | Experimental | Participants in this group received Qigong exercises four times per week for three weeks (12 sessions in total), while continuing their usual treatments. Receives: Behavioral: Qigong Exercises |
| Control Group | No intervention | Participants in this group continued their usual treatments without receiving Qigong exercises during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trait Anxiety Scores Measured by the State-Trait Anxiety Inventory (STAI-II)
Trait anxiety was assessed using the Trait Anxiety subscale of the State-Trait Anxiety Inventory (STAI-II), developed by Spielberger et al. The STAI-II measures an individual's general tendency to experience anxiety, regardless of specific situations or circumstances. The scale consists of 20 items rated on a four-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater trait anxiety.
Measured: Baseline, Week 3 (immediately post-intervention), and Week 4 (one-week follow-up)
Change in Depression Scores Measured by the Beck Depression Inventory (BDI)
Depression levels were assessed using the Beck Depression Inventory (BDI), developed by Beck et al. The BDI is a 21-item self-report instrument designed to assess the severity of depressive symptoms. Each item is scored on a four-point scale ranging from 0 to 3. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline, Week 3 (immediately post-intervention), and Week 4 (one-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Mar 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elçin babaoğlu, Uskudar University
- Investigators
- Elçin Babaoğlu Gülseven, PhD, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909447
- Sponsor's protocol ID
- QIGONG-SUD-2025-87
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Qigong Exercise on Anxiety and Depression Levels in Patients Receiving Treatment for Substance Use Disorder: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07909447
- Acronym / sponsor ID
- QIGONG-SUD-2025-87
- Conditions
- Substance Use Disorder (SUD), Anxiety, Depression
- Keywords
- Qigong, Shibashi Qigong, Substance Use Disorders, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 2 Nov 2026 (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.
Patients receiving inpatient treatment for substance use disorder may experience anxiety and depressive symptoms. Qigong is a mind-body exercise that combines gentle movements, breathing techniques, and relaxation. This study aimed to evaluate the effects of Qigong exercises on anxiety and depression levels. The study was conducted as a single-blind, randomized controlled trial. Patients meeting the predefined eligibility criteria were randomly assigned to either the intervention group or the control group. The intervention group participated in Shibashi Qigong exercises four times a week for three weeks (12 sessions in total), while the control group did not receive Qigong exercises. Both groups continued their usual treatments. Anxiety and depression levels were assessed using the State-Trait Anxiety Inventory (STAI) and the Beck Depression Inventory (BDI) at three time points: before the intervention, immediately after the three-week exercise program, and one week after its completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong Group | Experimental | Behavioral: Qigong ExercisesParticipants in this group received Qigong exercises four times per week for three weeks (12 sessions in total), while continuing their usual treatments. |
| Control Group | No intervention | –Participants in this group continued their usual treatments without receiving Qigong exercises during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being able to read and write and having no communication barriers.
- Receiving inpatient treatment for substance use disorder in a psychiatric unit.
- Having no comorbid psychiatric disorder other than substance use disorder.
- Having no diagnosis of an anxiety disorder or depression.
- Being 18 years of age or older.
Key exclusion criteria (7 listed)
- Being unable to read and write and having communication difficulties.
- Having acute psychotic symptoms.
- Having a comorbid psychiatric disorder other than substance use disorder.
- Having a diagnosis of an anxiety disorder or depression.
- Receiving treatment for a condition other than substance use disorder.
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 |
|---|---|---|
| Qigong ExercisesThe intervention consisted of a standardized Shibashi Qigong exercise program delivered in 40-minute group sessions, four times per week for three weeks, for a total of 12 sessions. Each session began with a 5-minute warm-up and 5 minutes of breathing exercises, followed by 10 minutes of relaxation movements. The next 10 minutes included free spinal movements, clockwise and counterclockwise horizontal rotations, side-to-side swaying, and simple spinal exercises. Each session concluded with 10 minutes of cool-down and progressive relaxation. | Behavioural | Qigong Group |
Primary outcome
Change in Trait Anxiety Scores Measured by the State-Trait Anxiety Inventory (STAI-II)
Time frame: Baseline, Week 3 (immediately post-intervention), and Week 4 (one-week follow-up)
Trait anxiety was assessed using the Trait Anxiety subscale of the State-Trait Anxiety Inventory (STAI-II), developed by Spielberger et al. The STAI-II measures an individual's general tendency to experience anxiety, regardless of specific situations or circumstances. The scale consists of 20 items rated on a four-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater trait anxiety.
Change in Depression Scores Measured by the Beck Depression Inventory (BDI)
Time frame: Baseline, Week 3 (immediately post-intervention), and Week 4 (one-week follow-up)
Depression levels were assessed using the Beck Depression Inventory (BDI), developed by Beck et al. The BDI is a 21-item self-report instrument designed to assess the severity of depressive symptoms. Each item is scored on a four-point scale ranging from 0 to 3. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
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 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality.
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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.
Elçin Babaoğlu Gülseven, PhD principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong Exercises in people with Substance Use Disorder (SUD) and Anxiety, run by Uskudar 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 7 inclusion and 7 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 2 Nov 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?
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?
Change in Trait Anxiety Scores Measured by the State-Trait Anxiety Inventory (STAI-II) (time frame: Baseline, Week 3 (immediately post-intervention), and Week 4 (one-week follow-up)). The study lists 2 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 2 Nov 2026.