Clinical trial NCT06817473: Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting
Official title: Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting - RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computerized Anxiety Sensitivity Treatment
Health Education Treatment
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to one of two treatment conditions (active CAST or control HET) and did not receive the other intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* inability to engage in any interoceptive exercises.

Primary outcomes:
measure: Anxiety Sensitivity Index-3
timeFrame: Baseline through Month 1 follow up
measure: PROMIS Anxiety Scale 8a
timeFrame: Baseline through Month 1 Follow Up
measure: PROMIS Depression Scale 8b
timeFrame: Baseline through Month 1 Follow Up
measure: Treatment Acceptability Questionnaire
timeFrame: Baseline through Month 1 follow up
measure: Treatment Engagement Questionnaire
timeFrame: Month 1 Follow Up
Secondary outcomes:
measure: Intolerance of Uncertainty-12
timeFrame: Baseline through Month 1 follow up
measure: Client Satisfaction Questionnaire
timeFrame: Baseline through Month 1 Follow Up
measure: Difficulties in Emotion Regulation Scale
timeFrame: Baseline through Month 1 follow up
Other outcomes:
measure: Group likingness/closeness
timeFrame: Baseline
measure: Berlin Numeracy Test
timeFrame: Baseline
Locations:
city: Tallahassee
country: United States
facility: Florida State University Psychology Clinic
state: Florida
Study officials:
References: