Florida State University Psychology Clinic
Tallahassee, Florida, 32304, United States
Completed
NCT Number: NCT06817473
Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting
* 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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- adults aged 18+ and ability to use a computer or smartphone.
Exclusion criteria
- inability to engage in any interoceptive exercises.
Treatment and study plan
CAST
BehavioralCAST 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
HET
BehavioralThe 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: Health Education Treatment, HEC, Health Education Control
Primary outcomes
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Anxiety Sensitivity Index-3
Time frame: 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
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PROMIS Anxiety Scale 8a
Time frame: 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.
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PROMIS Depression Scale 8b
Time frame: 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.
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Treatment Acceptability Questionnaire
Time frame: 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.
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Treatment Engagement Questionnaire
Time frame: 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.
Secondary outcomes
-
Intolerance of Uncertainty-12
Time frame: 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.
-
Client Satisfaction Questionnaire
Time frame: 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.
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Difficulties in Emotion Regulation Scale
Time frame: 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.
Other outcomes
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Group likingness/closeness
Time frame: Baseline
Self-report measure assessing how close group members felt with other members of their group (adapted from Byrne et al., 1971)
-
Berlin Numeracy Test
Time frame: Baseline
Brief measure of numerical ability (Cokely et al., 2011) with scores ranging from 0-4, higher scores indicate better numerical ability.
Sponsors and collaborators
Lead sponsor
Florida State University
Other
Registry information
Official study title
Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting - RCT
Acronym: Group CAST
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Feb 10, 2025
- Registry last updated
- Feb 10, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.