Theta- and Alpha-Tuned Meditation for Negative Symptoms in Schizophrenia

NCT07437365 | Completed

• 1 other identifier: HPC 001-08-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophenia Disorder

Keywords

schizophrenia; Negative symptoms; Meditation; Binaural beats; Alpha waves; Theta waves

Outcome Measures

Primary Outcomes (1)

• Negative symptoms

  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.

  6 weeks

Secondary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  6 weeks

Study Arms (1)

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.

Device: Alpha binaural beats; Device: Theta binaural beats

Interventions

Alpha binaural beats DEVICE

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.

Guided Meditation

Theta binaural beats DEVICE

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.

Guided Meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Hospital of the Cross: lead

Study Sites (1)

Psychiatric Hospital of the Cross

Beirut, Lebanon

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study was double-blinded. Both the participants and the principal investigator were blinded to group allocation to minimize expectancy and placebo effects. Only the study coordinator responsible for randomization and session assignment was aware of group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical physician(MD)

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: August 5, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)