The Concert Therapy: A Randomised Controlled Trial of a Non-Clinical, Arts-Based Well-being Intervention for Stress Regulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale (PSS-10)
研究概览
简要总结
The Concert Therapy is a non-clinical, art based well-being intervention designed to support stress regulation through a structured, concert like experience. The intervention integrates three sequential phases: calming music, guided breathing with gentle movement, and uplifting music. It is intended for use with adults experiencing everyday stress in non-clinical contexts and does not involve diagnosis or treatment.
This randomised controlled trial will compare The Concert Therapy with an active control condition consisting of relaxing music listening and quiet rest. Adult participants will be randomly assigned to one of the two conditions. The primary outcome is change in self-reported perceived stress measured before and immediately after the session. Secondary outcomes include mood and short term follow-up measures of well-being and stress.
The study aims to examine whether the structured, three phase design of The Concert Therapy leads to greater improvements in perceived stress compared with non-specific relaxation and music listening alone. The trial is designed as a non-clinical well-being study and does not constitute a clinical treatment trial.
详细描述
This study is a randomised controlled trial designed to evaluate a non-clinical, arts based well-being intervention known as The Concert Therapy. The study focuses on stress regulation and well-being in adults experiencing everyday stress in non-clinical contexts. The trial does not involve diagnosis, treatment, or clinical decision making and is not intended as a form of therapy or medical intervention.
The Concert Therapy is delivered as a single, structured session presented in a concert like format. The intervention follows a three phase sequence intended to support regulation through musical and embodied experience. The first phase involves calming music designed to support settling and relaxation. The second phase integrates guided breathing with gentle, optional movement to support embodied regulation and sustained presence. The third phase involves uplifting music intended to support gentle re-activation and a sense of closure. The session is facilitated in a group setting and may be delivered in person or online, depending on context.
Participants randomised to the intervention arm will attend one session of The Concert Therapy. Participants randomised to the control arm will attend a session of equivalent duration and setting involving relaxing music listening and quiet rest. The control condition is designed to match time, environment, and exposure to music while omitting the structured three phase sequence, guided breathing, and movement elements of The Concert Therapy.
Participants will complete self-report measures of perceived stress and mood before the session and immediately after the session. A short follow-up assessment will be conducted one week later to explore short term maintenance of effects. Adverse events and safety information will be collected after the session and at follow-up using a simple checklist.
The primary outcome of the study is change in self-reported perceived stress from baseline to immediately after the session. Secondary outcomes include changes in mood and well-being, as well as perceived stress at one week follow-up. Additional exploratory measures may be collected to support a broader understanding of participant experience and feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and data analysts will be blinded to group allocation. Participants and facilitators are not blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 65 years
- •Experiencing self-reported everyday stress in non-clinical contexts
- •Able to participate in gentle movement and remain seated or standing for the duration of the session
- •Able to understand the study information and provide informed consent
排除标准
- •Current treatment for serious cardiovascular or respiratory illness
- •Current use of medication that directly affects heart rate or stress response (for example, beta-blockers)
- •Pregnancy
- •Severe psychiatric illness requiring intensive treatment
- •Inability to understand the language used for the intervention and study procedures
研究组 & 干预措施
The Concert Therapy
Participants will attend a single session of The Concert Therapy, a non-clinical, arts based well-being intervention delivered in a concert like format. The session follows a structured three phase sequence consisting of calming music, guided breathing with gentle movement, and uplifting music.
干预措施: The Concert Therapy (Other)
Active Control
Participants will attend a single session of relaxing music listening and quiet rest in a similar setting and for a similar duration as the intervention arm. The session does not include the structured three phase sequence, guided breathing, or movement.
干预措施: Active Control: Relaxing Music and Quiet Rest (Other)
结局指标
主要结局
Perceived Stress Scale (PSS-10)
时间窗: Baseline (pre-session) to immediately post-session
Self-reported perceived stress measured using the 10 item Perceived Stress Scale (PSS-10)
次要结局
- Mood Visual Analogue Scales (VAS)(Baseline (pre-session) to immediately post-session)
- Well-being (WHO-5)(Baseline (pre-session) to 1-week follow-up)
- Perceived Stress Scale (PSS-10) at Follow-Up(Baseline (pre-session) to 1 week follow-up)
研究者
Behnam Khodarahmi
Founder and Lead Researcher
The Concert Therapy