Attention-Deficit/Hyperactivity Disorder (ADHD)
Conditions
Keywords
Binaural Beat, Attention-Deficit/Hyperactivity Disorder
Brief summary
This study will evaluate the feasibility and potential effects of a six-week, music-based binaural beats stimulation program in adults with attention-deficit/hyperactivity disorder (ADHD). Forty adults with ADHD will be randomly assigned to either a binaural beat stimulation group or a control group. Both groups will attend 12 supervised listening sessions over six weeks and listen to similar music for 20 minutes per session; however, only the intervention group's music will contain embedded binaural beats. Cognitive assessments will be completed before and after the intervention to evaluate changes in attention and memory. Session attendance and participant retention will also be examined to assess the feasibility and acceptability of the program.
Detailed description
This randomized controlled study will examine the feasibility, acceptability, and preliminary effects of a six-week, music-based binaural beats stimulation (BBS) intervention in adults with attention-deficit/hyperactivity disorder (ADHD). The study aims to enroll 40 adults between 18 and 55 years of age with a previous ADHD diagnosis. Participants will be randomly assigned to either the BBS intervention group or the control group, with approximately 20 participants in each group. During the first study visit, participants will provide informed consent and complete demographic and mental health questionnaires. ADHD symptoms will be assessed using the Adult ADHD Self-Report Scale. Participants will also complete baseline cognitive assessments using the CogniFit Research platform. The assessment battery will evaluate cognitive abilities related to attention, memory, coordination, and reasoning. Participants will then attend 12 supervised listening sessions over six weeks, with two sessions conducted each week. Each listening session will include 20 minutes of music delivered through headphones. Participants assigned to the intervention group will listen to music containing embedded binaural beats, while participants assigned to the control group will listen to similar music without binaural beats. Before each listening session, participants will rest quietly for five minutes, after which heart rate and blood pressure will be measured and readiness to participate will be assessed. After the six-week intervention, participants will complete the same cognitive assessment battery administered at baseline. Changes in cognitive outcomes from baseline to six weeks will be compared between the intervention and control groups. Session attendance and participant retention will also be evaluated as indicators of intervention feasibility and acceptability.
Interventions
BEHAVIORALMusic-Based Binaural Beats Stimulation
Participants will receive 12 supervised binaural beats stimulation sessions over six weeks, with two sessions conducted per week. During each session, participants will listen through headphones to 20 minutes of music containing embedded binaural beats. Music will be selected based on each participant's preferred genre from available options.
BEHAVIORALMusic Listening Without Binaural Beats
Participants will receive 12 supervised music-listening sessions over six weeks, with two sessions conducted per week. During each session, participants will listen through headphones to 20 minutes of music without embedded binaural beats. The music, listening duration, session schedule, setting, and available genre options will be similar to those provided to the experimental group.
Sponsors
California State University, San Bernardino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are randomly assigned to listen to either music containing embedded binaural beats or similar music without binaural beats. Participants are not informed which listening condition they receive.
Intervention model description
Participants are randomly assigned in parallel to either a six-week music-based binaural beat stimulation intervention or a control condition involving similar music without binaural beats.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 55 years 2. Previous diagnosis of attention-deficit/hyperactivity disorder (ADHD) made by a qualified healthcare professional and supported by the Adult ADHD Self-Report Scale, version 1.1 (ASRS-v1.1) 3. Willing to wear headphones during the listening sessions 4. Able and willing to attend 12 listening sessions conducted twice weekly over six weeks -
Exclusion criteria
1. Anticipated absence from the study area for more than seven days during the two-month study period 2. Uncorrectable hearing impairment that would prevent adequate delivery of music through headphones 3. Acute psychiatric condition, such as depression 4. Intellectual or developmental disability that could interfere with study participation 5. Acute medical condition resulting in sensory impairment 6. Initiation of, or a change in dosage of, stimulant, antipsychotic, or analgesic medication within the previous month 7. Anticipated change in stimulant, antipsychotic, or analgesic medication during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility | Throughout the six-week intervention | Feasibility will be evaluated using the numbers of participants screened, eligible, and enrolled; the proportion of enrolled participants who complete the intervention and post-intervention assessments; and the number and percentage of the 12 scheduled listening sessions completed by each participant. |
| Participant Acceptability | Throughout the six-week intervention | Acceptability will be assessed during each intervention session by documenting changes in health status, perceived positive or negative effects, and any discomfort or concerns. After each session, participants will rate their enjoyment on a 5-point scale ranging from 1 (not at all enjoyable) to 5 (extremely enjoyable) and provide open-ended feedback about their mood, emotions, relaxation, and other perceived effects. Responses will be summarized descriptively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Attention Performance | Baseline and immediately after the six-week intervention | Change from baseline in attention-related performance measured using the CogniFit cognitive assessment battery, including the Psychomotor Vigilance Test, Stroop Test, and Divided Attention Test. Changes of the scores will be interpreted according to the scoring method for each CogniFit test. |
| Change in Memory Performance | Baseline and immediately after the six-week intervention | Change from baseline in memory-related performance measured using the CogniFit cognitive assessment battery, including the Visual Working Memory Span Test and Multimodal Lexical Memory Test. Changes of the scores will be interpreted according to the scoring method for each CogniFit test. |
Countries
United States
Contacts
CONTACTZhaojing Chen, Ph.D.
Outcome results
None listed