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

NCT06817473 | Completed

• 1 other identifier: STUDY00004267
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Anxiety Sensitivity Index-3

  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

  Baseline through Month 1 follow up

• PROMIS Anxiety Scale 8a

  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.

  Baseline through Month 1 Follow Up

• PROMIS Depression Scale 8b

  8 item self-report measure indexing depressive symptoms (Polkonis et al., 2014). Scores range from 8-40 with higher scores reflecting worse depression symptoms.

  Baseline through Month 1 Follow Up

• Treatment Acceptability Questionnaire

  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.

  Baseline through Month 1 follow up

• Treatment Engagement Questionnaire

  Participants were given two items assessing how frequently they: 1) thought about CAST content in the past month; 2) engaged in interoceptive exposure practice.

  Month 1 Follow Up

Secondary Outcomes (3)

• Intolerance of Uncertainty-12

  Baseline through Month 1 follow up

• Client Satisfaction Questionnaire

  Baseline through Month 1 Follow Up

• Difficulties in Emotion Regulation Scale

  Baseline through Month 1 follow up

Other Outcomes (2)

• Group likingness/closeness

  Baseline

• Berlin Numeracy Test

  Baseline

Study Arms (2)

CAST

EXPERIMENTAL

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.

Behavioral: CAST

HET

PLACEBO COMPARATOR

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.

Behavioral: HET

Interventions

CAST 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.

Also known as: Computerized Anxiety Sensitivity Treatment

CAST

HET 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.

Also known as: Health Education Treatment, HEC, Health Education Control

HET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• inability to engage in any interoceptive exercises.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University Psychology Clinic

Tallahassee, Florida, 32304, United States

Location

Related Publications (1)

• 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.

  PMID: 40435564 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Professor

Model Details: Participants were randomized to one of two treatment conditions (active CAST or control HET) and did not receive the other intervention.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: February 21, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)