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

NCT ID: NCT06817473

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2025-01-15

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.

Conditions

Computerized Anxiety Sensitivity Treatment; Health Education Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CAST

Computerized anxiety sensitivity treatment (CAST), which has been used by researchers already in many RCTs. This involves 30 minutes of psychoeducational video material delivered via computer presentation followed by 30 minutes of repeated interoceptive exposure practice exercises such as 60 seconds of breathing through a coffee straw, shaking head from side to side, and looking into a mirror.

Group Type: EXPERIMENTAL

CAST

Intervention Type: BEHAVIORAL

CAST is a transdiagnostic cognitive behavioral therapy (CBT)-based protocol designed to address elevated AS, particularly the amplification of cognitive stress symptoms including perceived confusion and memory problems. CAST is a fully computerized, 1-hour intervention. CAST contains video animation and audio narration throughout, as well as interactive features (e.g., brief quizzes to promote comprehension). Procedures draw heavily on standard CBT techniques; AS, a core vulnerability for anxiety and depression is targeted using these procedures. In this study, participants complete CAST as a group alongside other participants.

HET

Developed as a 30-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial.

Group Type: PLACEBO_COMPARATOR

HET

Intervention Type: BEHAVIORAL

The HET protocol covers standard healthy lifestyle behaviors as well as broad coping strategies to address stress. HET is a fully computerized 1-hour control condition focused on increasing healthy behaviors and decreasing unhealthy behaviors. Content includes healthy eating, hydration, sleep and rest, stress management as well as other healthy lifestyle tips. HET was administered in a group format for this study.

Interventions

CAST

CAST is a transdiagnostic cognitive behavioral therapy (CBT)-based protocol designed to address elevated AS, particularly the amplification of cognitive stress symptoms including perceived confusion and memory problems. CAST is a fully computerized, 1-hour intervention. CAST contains video animation and audio narration throughout, as well as interactive features (e.g., brief quizzes to promote comprehension). Procedures draw heavily on standard CBT techniques; AS, a core vulnerability for anxiety and depression is targeted using these procedures. In this study, participants complete CAST as a group alongside other participants.

Intervention Type: BEHAVIORAL

HET

The HET protocol covers standard healthy lifestyle behaviors as well as broad coping strategies to address stress. HET is a fully computerized 1-hour control condition focused on increasing healthy behaviors and decreasing unhealthy behaviors. Content includes healthy eating, hydration, sleep and rest, stress management as well as other healthy lifestyle tips. HET was administered in a group format for this study.

Intervention Type: BEHAVIORAL

Other Intervention Names

Computerized Anxiety Sensitivity Treatment; Health Education Treatment; HEC; Health Education Control

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• inability to engage in any interoceptive exercises.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Norman Schmidt

Distinguished Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University Psychology Clinic

Tallahassee, Florida, United States

Countries

United States

References

Schubert FT, Morabito DM, Schmidt NB. Examining the efficacy of the computerized anxiety sensitivity treatment in a guided, group format: A randomized controlled trial. Behav Res Ther. 2025 Aug;191:104785. doi: 10.1016/j.brat.2025.104785. Epub 2025 May 20.

Reference Type: DERIVED

PMID: 40435564 (View on PubMed)

Other Identifiers

STUDY00004267

Identifier Type: -

Identifier Source: org_study_id