Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting

Not Applicable

Completed

• Conditions: Computerized Anxiety Sensitivity Treatment; Health Education Treatment

• Registration Number: NCT06817473
• Lead Sponsor: Florida State University

Brief Summary

* Statement of the Research Study. Participants are being invited to volunteer to take part in our research study. It is up to participants whether to choose to take part or not. There will be no penalty or loss of benefits to choosing not to take part or decide later not to take part.

* Purpose. The reason that the researchers are doing this research is to evaluate the effectiveness and feasibility of administering a computerized anxiety intervention in a setting of five or more individuals. This intervention has already been tested and shown promise with individuals, and researchers want to see if it will function in a group setting as well.

* Duration. Researchers think that taking part in our study will last approximately two hours, with an additional follow-up survey one month later to be completed at home via computer or smartphone.

* Research Activities. Participants will first be asked to complete several questionnaires dealing with your thoughts and feelings. Once these questionnaires are completed, participants will be assigned to one of two groups, with each group viewing one of two computerized presentations and completing some group exercises afterward. Once participants have completed the designated intervention, participants will then be asked to fill out surveys once again, which will complete the study appointment. One month following the appointment, participants will be sent surveys once again and will be asked to complete them at home.

Risks: The risks or discomforts to participants while taking part in this research include temporary distress or anxiety pr potentially feeling mild discomfort answering questions about your thoughts and feelings.

Benefits: As a result of taking part in this research, participants may experience improvements in mental health.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Status Verified: 2025-01
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• adults aged 18+ and ability to use a computer or smartphone.

Exclusion Criteria

• inability to engage in any interoceptive exercises.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Engagement Questionnaire	Month 1 Follow Up	Participants were given two items assessing how frequently they: 1) thought about CAST content in the past month; 2) engaged in interoceptive exposure practice.
PROMIS Depression Scale 8b	Baseline through Month 1 Follow Up	8 item self-report measure indexing depressive symptoms (Polkonis et al., 2014). Scores range from 8-40 with higher scores reflecting worse depression symptoms.
Treatment Acceptability Questionnaire	Baseline through Month 1 follow up	7-item self-report measure used in prior studies (Short et al., 2017). Scores range from 0-21 with higher scores indicating more favorable acceptability ratings.
Anxiety Sensitivity Index-3	Baseline through Month 1 follow up	18 item self-report measure indexing anxiety sensitivity (Taylor et al., 2007). Scores range from 0-72 with higher scores indicating more severe anxiety sensitivity
PROMIS Anxiety Scale 8a	Baseline through Month 1 Follow Up	8-item self-report measure indexing overall anxiety (Pilkonis et al., 2011). Scores range from 8 to 40 with higher scores reflecting worse anxiety symptoms.

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire	Baseline through Month 1 Follow Up	A modified version of the Client Satisfaction Questionnaire (CSQ) will be administered to assess treatment acceptability. Scores range from 8-32 with higher scores reflecting more favorable acceptability ratings.
Intolerance of Uncertainty-12	Baseline through Month 1 follow up	12 item self-report measure indexing intolerance of uncertainty (Carleton et al., 2007). Scores range from 12-60 with higher scores reflecting worse intolerance of uncertainty.
Difficulties in Emotion Regulation Scale	Baseline through Month 1 follow up	16 item self-report measure indexing emotional dysregulation (DERS-16, Bjureberg et al., 2016). Scores range from 16 to 80 with higher scores reflecting worse emotion regulation difficulties.

Trial Locations

Locations (1)

Florida State University Psychology Clinic; 🇺🇸 Tallahassee, Florida, United States