Schizophenia DisorderALPHATH-SCZNCT07437365
Theta- and Alpha-Tuned Meditation for Negative Symptoms in Schizophrenia
A study testing Alpha binaural beats and Theta binaural beats in people with Schizophenia Disorder, run by Psychiatric Hospital of the Cross at 1 site in Lebanon.
Trial summary
This study done at the psychiatrics hospital of the cross Lebanon examined whether guided meditation combined with special sound stimulation (binaural beats) could help reduce negative symptoms of schizophrenia, such as low motivation and social withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder
- What is being tested?
- Alpha binaural beats and Theta binaural beats
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteLebanon
- Study dates
- 5 Aug 2025to 31 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients at the psychiatrics hospital of the cross
- Aged between 18 and 65 years
- Diagnosed with schizophrenia according to the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5)
- Clinically stable, receiving a consistent dose of antipsychotic medication for at least 3 months before recruitment
Who cannot join
- Acute psychiatric symptoms requiring immediate intervention or hospitalization
- Current diagnosis of substance use disorder
- Documented history of non-compliance with medical treatment
- Hearing impairments that could affect accurate perception of auditory stimuli such as binaural beats
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Theta and Alpha Frequency-Tuned Meditation on Negative Symptoms in Schizophrenia: A Randomized Controlled Trial
This study done at the psychiatrics hospital of the cross Lebanon examined whether guided meditation combined with special sound stimulation (binaural beats) could help reduce negative symptoms of schizophrenia, such as low motivation and social withdrawal. Ninety inpatients participated in a six-week program and were assigned to meditation alone or meditation combined with either alpha- or theta-frequency sound stimulation.
Results showed that patients who received meditation with binaural beats improved more than those who had meditation alone. The greatest improvement was seen in the theta-frequency group. Although not all differences were statistically significant, the findings suggest that this simple, low-cost, non-medication approach may help reduce persistent negative symptoms. Larger studies are needed to confirm these results.
Read the detailed description
Schizophrenia is a mental health condition that can cause a wide range of symptoms. While medications often help reduce positive symptoms such as hallucinations or delusions, many patients continue to experience "negative symptoms," like reduced motivation, limited emotional expression, and social withdrawal. These symptoms can have a major impact on daily life and are often harder to treat. Recent research suggests that mind-body interventions, such as meditation and specific sound-based techniques called binaural beats, can influence brain activity linked to attention, memory, and emotional regulation. Alpha and theta brainwave patterns are often disrupted in people with schizophrenia, which may contribute to negative symptoms.
This study, conducted at the psychiatric hospital of the cross in Lebanon, explored whether pairing guided meditation with frequency-specific binaural beats could help reduce negative symptoms in patients with schizophrenia. The study also compared two types of sound frequencies-alpha and theta-to see which might be more effective. Ninety stable inpatients diagnosed with schizophrenia participated in the study. They were randomly assigned to one of three groups: Guided meditation alone, Meditation plus alpha-frequency binaural beats, Meditation plus theta-frequency binaural beats. Participants attended sessions regularly over six weeks. Their symptoms were measured before and after the program using validated Arabic clinical scales. Patients who received meditation combined with binaural beats showed greater improvement in negative symptoms compared to those who received meditation alone. The most notable improvements were seen in the theta-frequency group, which also appeared more engaged during the sessions. However, individual responses varied, and not all differences between groups were statistically significant. Mind-body approaches like meditation and binaural beats may offer new ways to support patients with schizophrenia, helping improve motivation, emotional engagement, and overall quality of life-without relying solely on medication.
- Conditions
- Schizophenia Disorder
- Being tested
- Alpha binaural beats, Theta binaural beats
- Keywords
- schizophrenia, Negative symptoms, Meditation, Binaural beats, Alpha waves, Theta waves
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha binaural beatsDevice
Group A Intervention: Participants in this group listened to pre-recorded guided meditation sessions that included affirmations targeting negative symptoms, combined with calming background music and alpha-frequency binaural beats (10 Hz). To maintain engagement, four unique meditation scripts were prepared, with one script delivered per session day and repeated in sequence over the six-week intervention period. All sessions were delivered using high-fidelity wireless headphones to ensure consistent and clear auditory stimulation. This behavioral intervention aimed to improve motivation, emotional expression, and social engagement in patients with schizophrenia.
Theta binaural beatsDevice
Group B Intervention: Participants in this group listened to the same pre-recorded guided meditation sessions and calming background music as Group A, but the audio was combined with theta-frequency binaural beats (6 Hz). Four unique meditation scripts were delivered in sequence, one per session day, and repeated over the six-week intervention period to maintain engagement. Sessions were administered using high-fidelity wireless headphones to ensure clear and consistent delivery. This behavioral intervention aimed to enhance motivation, emotional expression, and social engagement in patients with schizophrenia, with theta-frequency stimulation intended to provide additional modulation of brain rhythms.
| Study group | Role | What they receive |
|---|---|---|
| Guided Meditation | Active comparator | Participants in this active control group listened to pre-recorded guided meditation sessions with background music. The recordings were standardized and identical for all participants in this group to ensure consistency. No additional auditory stimulation (binaural beats) was added, allowing this group to serve as a control for the effects of meditation alone. All sessions were delivered in a quiet, comfortable environment, and participants were instructed to listen attentively for the full duration of the recording. Receives: Device: Alpha binaural beats; Device: Theta binaural beats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS) Negative symptoms
The primary outcome of this study was clinical symptoms in patients with schizophrenia. These symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS). Evaluations were conducted at baseline and after the six-week intervention to examine changes in positive, negative, and general psychopathology domains.
Measured: 6 weeks
Secondary outcomes (1)
Self-evaluation of Negative Symptoms (SNS)
The secondary outcome of this study was the negative symptoms in patients with schizophrenia. These symptoms were evaluated using a validated scale, the Self-evaluation of Negative Symptoms (SNS). Assessments were conducted at baseline and after the six-week intervention to examine changes in specific symptoms, including blunted affect, emotional withdrawal, reduced motivation, and social engagement.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Aug 2025
- Primary completion16 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This randomized interventional study enrolled 90 participants who were assigned equally to three groups using computer-generated randomization (1:1:1). Each group included 30 patients: Group A received guided meditation with alpha-frequency binaural beats, Group B received guided meditation with theta-frequency binaural beats, and Group C received guided meditation alone. This design ensured balanced group distribution and allowed comparison of the effects of the different interventions on negative symptoms in schizophrenia.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the Cross
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouan Zoghbi, Psychiatric Hospital of the Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437365
- Sponsor's protocol ID
- HPC 001-08-2025
- Acronym
- ALPHATH-SCZ
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data will not be shared with other researchers, due to the sensitive nature of psychiatric patient information and the need to ensure participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Theta and Alpha Frequency-Tuned Meditation on Negative Symptoms in Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07437365
- Acronym / sponsor ID
- ALPHATH-SCZ / HPC 001-08-2025
- Conditions
- Schizophenia Disorder
- Keywords
- schizophrenia, Negative symptoms, Meditation, Binaural beats, Alpha waves, Theta waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Psychiatric Hospital of the CrossUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 27 Feb 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.
This study done at the psychiatrics hospital of the cross Lebanon examined whether guided meditation combined with special sound stimulation (binaural beats) could help reduce negative symptoms of schizophrenia, such as low motivation and social withdrawal. Ninety inpatients participated in a six-week program and were assigned to meditation alone or meditation combined with either alpha- or theta-frequency sound stimulation.
Results showed that patients who received meditation with binaural beats improved more than those who had meditation alone. The greatest improvement was seen in the theta-frequency group. Although not all differences were statistically significant, the findings suggest that this simple, low-cost, non-medication approach may help reduce persistent negative symptoms. Larger studies are needed to confirm these results.
Detailed description
Schizophrenia is a mental health condition that can cause a wide range of symptoms. While medications often help reduce positive symptoms such as hallucinations or delusions, many patients continue to experience "negative symptoms," like reduced motivation, limited emotional expression, and social withdrawal. These symptoms can have a major impact on daily life and are often harder to treat. Recent research suggests that mind-body interventions, such as meditation and specific sound-based techniques called binaural beats, can influence brain activity linked to attention, memory, and emotional regulation. Alpha and theta brainwave patterns are often disrupted in people with schizophrenia, which may contribute to negative symptoms.
This study, conducted at the psychiatric hospital of the cross in Lebanon, explored whether pairing guided meditation with frequency-specific binaural beats could help reduce negative symptoms in patients with schizophrenia. The study also compared two types of sound frequencies-alpha and theta-to see which might be more effective. Ninety stable inpatients diagnosed with schizophrenia participated in the study. They were randomly assigned to one of three groups: Guided meditation alone, Meditation plus alpha-frequency binaural beats, Meditation plus theta-frequency binaural beats. Participants attended sessions regularly over six weeks. Their symptoms were measured before and after the program using validated Arabic clinical scales. Patients who received meditation combined with binaural beats showed greater improvement in negative symptoms compared to those who received meditation alone. The most notable improvements were seen in the theta-frequency group, which also appeared more engaged during the sessions. However, individual responses varied, and not all differences between groups were statistically significant. Mind-body approaches like meditation and binaural beats may offer new ways to support patients with schizophrenia, helping improve motivation, emotional engagement, and overall quality of life-without relying solely on medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This randomized interventional study enrolled 90 participants who were assigned equally to three groups using computer-generated randomization (1:1:1). Each group included 30 patients: Group A received guided meditation with alpha-frequency binaural beats, Group B received guided meditation with theta-frequency binaural beats, and Group C received guided meditation alone. This design ensured balanced group distribution and allowed comparison of the effects of the different interventions on negative symptoms in schizophrenia.
| Arm | Type | Receives |
|---|---|---|
| Guided Meditation | Active comparator | Device: Alpha binaural beats, Device: Theta binaural beatsParticipants in this active control group listened to pre-recorded guided meditation sessions with background music. The recordings were standardized and identical for all participants in this group to ensure consistency. No additional auditory stimulation (binaural beats) was added, allowing this group to serve as a control for the effects of meditation alone. All sessions were delivered in a quiet, comfortable environment, and participants were instructed to listen attentively for the full duration of the recording. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients at the psychiatrics hospital of the cross
- Aged between 18 and 65 years
- Diagnosed with schizophrenia according to the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5)
- Clinically stable, receiving a consistent dose of antipsychotic medication for at least 3 months before recruitment
Key exclusion criteria (4 listed)
- Acute psychiatric symptoms requiring immediate intervention or hospitalization
- Current diagnosis of substance use disorder
- Documented history of non-compliance with medical treatment
- Hearing impairments that could affect accurate perception of auditory stimuli such as binaural beats
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 |
|---|---|---|
| Alpha binaural beatsGroup A Intervention: Participants in this group listened to pre-recorded guided meditation sessions that included affirmations targeting negative symptoms, combined with calming background music and alpha-frequency binaural beats (10 Hz). To maintain engagement, four unique meditation scripts were prepared, with one script delivered per session day and repeated in sequence over the six-week intervention period. All sessions were delivered using high-fidelity wireless headphones to ensure consistent and clear auditory stimulation. This behavioral intervention aimed to improve motivation, emotional expression, and social engagement in patients with schizophrenia. | Device | Guided Meditation |
| Theta binaural beatsGroup B Intervention: Participants in this group listened to the same pre-recorded guided meditation sessions and calming background music as Group A, but the audio was combined with theta-frequency binaural beats (6 Hz). Four unique meditation scripts were delivered in sequence, one per session day, and repeated over the six-week intervention period to maintain engagement. Sessions were administered using high-fidelity wireless headphones to ensure clear and consistent delivery. This behavioral intervention aimed to enhance motivation, emotional expression, and social engagement in patients with schizophrenia, with theta-frequency stimulation intended to provide additional modulation of brain rhythms. | Device | Guided Meditation |
Primary outcome
Positive and Negative Syndrome Scale (PANSS) Negative symptoms
Time frame: 6 weeks
The primary outcome of this study was clinical symptoms in patients with schizophrenia. These symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS). Evaluations were conducted at baseline and after the six-week intervention to examine changes in positive, negative, and general psychopathology domains.
1 secondary outcome
Self-evaluation of Negative Symptoms (SNS)
Time frame: 6 weeks
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 3 Nov 2026.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared with other researchers, due to the sensitive nature of psychiatric patient information and the need to ensure participant confidentiality and privacy.
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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 Alpha binaural beats and Theta binaural beats in people with Schizophenia Disorder, run by Psychiatric Hospital of the Cross at 1 site in Lebanon.
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 4 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 3 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 Lebanon. 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?
Positive and Negative Syndrome Scale (PANSS) Negative symptoms (time frame: 6 weeks). 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 3 Nov 2026.