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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Computerized Anxiety Sensitivity Treatment; Health Education Treatment
• Intervention / Treatment: Behavioral: CAST; Behavioral: HET

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32304
      • Florida State University Psychology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• inability to engage in any interoceptive exercises.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: Computerized Anxiety Sensitivity Treatment
Placebo Comparator: 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.	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.; Other Names: HEC; Health Education Treatment; Health Education Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerance of Uncertainty-12	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.	Baseline through Month 1 follow up
Client Satisfaction Questionnaire	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.	Baseline through Month 1 Follow Up
Difficulties in Emotion Regulation Scale	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.	Baseline through Month 1 follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group likingness/closeness	Self-report measure assessing how close group members felt with other members of their group (adapted from Byrne et al., 1971)	Baseline
Berlin Numeracy Test	Brief measure of numerical ability (Cokely et al., 2011) with scores ranging from 0-4, higher scores indicate better numerical ability.	Baseline

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: STUDY00004267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No