Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting - RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Florida State University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Treatment Engagement Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •adults aged 18+ and ability to use a computer or smartphone.
Exclusion Criteria
- •inability to engage in any interoceptive exercises.
Arms & Interventions
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.
Intervention: CAST (Behavioral)
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.
Intervention: HET (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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
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.
Secondary Outcomes
- Client Satisfaction Questionnaire(Baseline through Month 1 Follow Up)
- Intolerance of Uncertainty-12(Baseline through Month 1 follow up)
- Difficulties in Emotion Regulation Scale(Baseline through Month 1 follow up)
Investigators
Norman Schmidt
Distinguished Research Professor
Florida State University