- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437365
Theta- and Alpha-Tuned Meditation for Negative Symptoms in Schizophrenia (ALPHATH-SCZ)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beirut, Lebanon
- Psychiatric Hospital of the Cross
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Guided Meditation
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Negative symptoms
Time Frame: 6 weeks
|
The primary 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.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 6 weeks
|
The secondary 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.
|
6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HPC 001-08-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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