Understanding of Participation Trends Within Generalized Anxiety Disorder Patients Involved in Clinical Trials

NCT06254157 | Not Yet Recruiting

• 1 other identifier: 57777066
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Typically, certain demographic groups tend to participate more in medical research. However, there is insufficient research explaining the trial characteristics that influence the involvement of these specific demographics. This study aims to collect extensive data on the clinical trial experiences of individuals with generalized anxiety disorder. The goal is to identify the factors that hinder a patient's enrollment or completion of a trial. Additionally, the research will examine the data from various demographic perspectives to identify recurring patterns that could offer valuable insights for future generalized anxiety disorder patients.

Conditions

Generalized Anxiety Disorder

Keywords

generalized anxiety disorder

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a generalized anxiety disorder clinical research.

  3 months

• Number of generalized anxiety disorder study participants who remain in clinical study until completion.

  12 months

Eligibility Criteria

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

Study Population

Individuals with generalized anxiety disorder who are actively contemplating involvement in a clinical trial but have not yet completed the enrollment and randomization process.

You may qualify if:

• Confirmed diagnosis of generalized anxiety disorder
• Participant must be 18 years of age or older
• Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

You may not qualify if:

• Pregnant or lactating woman
• Participant is actively receiving study therapy in another
• Inability to provide written informed consent

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Slee A, Nazareth I, Bondaronek P, Liu Y, Cheng Z, Freemantle N. Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. Lancet. 2019 Feb 23;393(10173):768-777. doi: 10.1016/S0140-6736(18)31793-8. Epub 2019 Jan 31.

  PMID: 30712879 BACKGROUND

• Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.

  PMID: 18363421 BACKGROUND

• Santiago J, Akeman E, Kirlic N, Clausen AN, Cosgrove KT, McDermott TJ, Mathis B, Paulus M, Craske MG, Abelson J, Martell C, Wolitzky-Taylor K, Bodurka J, Thompson WK, Aupperle RL. Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder. Trials. 2020 Jan 6;21(1):17. doi: 10.1186/s13063-019-3802-9.

  PMID: 31907032 BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)