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

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• Anxiety Disorders 4,868

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 73 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Study arms

• 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

• 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

Interventions

• BehavioralCAST

  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

• BehavioralHET

  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

Primary outcomes

1. 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

   Time frame: Baseline through Month 1 follow up

2. 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.

   Time frame: Baseline through Month 1 Follow Up

3. 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.

   Time frame: Baseline through Month 1 Follow Up

4. 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.

   Time frame: Baseline through Month 1 follow up

5. 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.

   Time frame: Month 1 Follow Up

Secondary outcomes

1. 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.

   Time frame: Baseline through Month 1 follow up

2. 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.

   Time frame: Baseline through Month 1 Follow Up

3. 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.

   Time frame: Baseline through Month 1 follow up

Other outcomes

1. Group likingness/closeness

   Self-report measure assessing how close group members felt with other members of their group (adapted from Byrne et al., 1971)

   Time frame: Baseline

2. Berlin Numeracy Test

   Brief measure of numerical ability (Cokely et al., 2011) with scores ranging from 0-4, higher scores indicate better numerical ability.

   Time frame: Baseline

Individual participant data

Plan to share: No