Nubellum Research is investigating the effectiveness of open-label placebo treatments in anxiety sufferers.

Participation in our remote Anxiety Study is simple, you can do it safely from your home.

All study participants will receive an in-home self study kit with instructions and a 28 day supply of open-label clinical-grade placebo capsules.

Study participants will gain insightful information about effective and practical treatment strategies for anxiety. 

 

1

Follow a daily treatment protocol and mindfulness exercises.

2

Maintain a simple daily progress journal to track your progress.

3

Provide anonymous weekly responses to our study check-in questions.

With this research we are investigating the capacity to activate natural healing mechanisms with open-label placebo treatments.

  1. ‘Open-label’ placebos are given with the recipient's full knowledge that it is a placebo

  2. Placebos may help to alleviate anxiety symptoms by triggering the release of neurotransmitters in your brain

  3. Placebos may also improve the results of active medicines or supplements

 

Study Details

We will assess the effectiveness of placebo pill treatments for patients with anxiety disorders (generalized anxiety disorder, panic disorder, agoraphobia, and social anxiety disorder), by randomizing patients to eight weeks of (1) mindfulness ritual with placebo pills or (2), mindfulness ritual practice alone.

Based on our previous research, we anticipate that 276 study participants will complete the protocol after 25% dropout; however treatment satisfaction including dropout and intent-to-treatment outcomes will also be important assessments to guide conclusions about patient preferences and treatment responses.

Upon completion, this study will provide information to participants about known effective and acceptable treatment strategies for anxiety.

Who Can Join

  1. English speaking Men and women between age 18 and 75 years old.

  2. Have experienced mild to severe anxiety symptoms in the previous 30 days prior to enrollment, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia

  3. Must understand study procedure and willing to participate in studies and treatment as assigned.


  4. Participants must be able to give informed consent to the study procedures.

Who is Excluded

  1. Individuals who have experienced suicidal thoughts or have attempted suicide in the past 12 months.

  2. Individuals who are not able to complete a 5 minute anonymous online questionnaire once each week for 4 consecutive weeks.

 

Eligibility Criteria

We aim to enroll 368 participants total in the United States.  With a projected dropout rate of 25%, we expect 276 completers.  Subjects must be between 18-75 years of age, have an anxiety disorder, and agree to participate in this study.

 

About the Study

We will examine several secondary outcome measures and exploratory outcomes. Overall Anxiety Severity and Impairment Scale (OASIS) is the secondary measure of anxiety symptoms. To assess satisfaction/acceptability of treatment, we will use a Client Satisfaction Questionnaire (CSQ) and a Reactions to Treatment Questionnaire (RTQ). To assess sleep outcomes, we will use the Pittsburgh Sleep Quality Index (PSQI), The Beck Anxiety Inventory (BAI) is a 21-item self-report inventory designed to measure severity of anxiety symptoms in psychiatric populations. The PROMIS - Emotional Distress scales (ED) will be used to assess emotional distress in the past 7 days, including depressive symptoms, anxiety symptoms, and anger. Other patient-reported measures include the Penn State Worry Questionnaire (PSWQ), the Inventory of Complicated Grief (ICG), and the Health Performance Questionnaire (HPQ). We will also use the Quick Inventory of Depressive Symptomatology, Self-Report, or QIDS-SR to measure depression severity including suicidality Other clinician-reported outcomes include the Liebowitz Social Anxiety Scale (LSAS), the Panic Disorder Severity Scale (PDSS), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), the Clinician Global Impression-Severity and Improvement Scales (CGI-S and CGI-I), and the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER).

Principal Investigator

Dr. Viviënne van de Walle, MD, PHD

Dr. Van de Walle studied medicine both at the University of Maastricht – The Netherlands and at the University of Oxford - UK. In addition to her MD degree, she holds degrees in Genetics, Pediatrics, and Gynecology. 

For more information on the Study Sponsor (Nubellum Research), visit www.nubellum.com on the Internet.