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Clinical Trials/NCT03074669
NCT03074669
Unknown
N/A

Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms

West University of Timisoara1 site in 1 country80 target enrollmentMarch 15, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorder/Anxiety State
Sponsor
West University of Timisoara
Enrollment
80
Locations
1
Primary Endpoint
Changes in Anxiety Sensitivity Index (ASI)
Last Updated
8 years ago

Overview

Brief Summary

The main objective of this study is to test the effectiveness of an Internet-delivered Acceptance and Commitment Therapy (ACT) program in reducing anxiety symptoms.

Detailed Description

The purpose of this study is to test the effectiveness and level of acceptability of an Internet-delivered Acceptance and Commitment Therapy (ACT) program in reducing symptoms of anxiety. The effectiveness of the intervention will be compared with a wait-list control group using a randomized control trial (RCT) design. The participants with high / clinical levels of anxiety from the active treatment group will have the opportunity to read seven ACT modules and receive personalized feedback for their completed homework assignments. The intervention will be delivered online and participants will have seven weeks to complete the seven modules (we might add one extra week of treatment for all participants in the event they need to compensate the treatment delays accumulated during the previous seven weeks).

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
January 30, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • be fluent in Romanian
  • be over 18 years of age
  • have high levels of anxiety
  • have access to an Internet-connected computer

Exclusion Criteria

  • suicidal ideation
  • substance abuse
  • severe psychiatric disorders
  • a recent change in psychotropic medication (i.e., the dose has been changed within the last month)

Outcomes

Primary Outcomes

Changes in Anxiety Sensitivity Index (ASI)

Time Frame: Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)

The ASI was designed to identify fear of somatic and cognitive symptoms of anxiety due to a belief that these symptoms may be dangerous or harmful. The scale is unidimensional and the total score rages from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.

Secondary Outcomes

  • Penn State Worry Questionnaire (PSWQ)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Social Phobia Inventory (SPIN)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Yale-Brown Obsessive Compulsive Scale (YBOCS)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Panic Disorder Severity Scale - Self Report (PDSS-SR)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Beck Depression Inventory-II (BDI-II)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Overall Anxiety Severity and Impairment Scale (OASIS)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Overall Depression Severity and Impairment Scale (ODSIS)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)])
  • Acceptance and Action Questionnaire 2 (AAQ2)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Mindful Attention Awareness Scale (MAAS)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Believability of Anxious Feelings and Thoughts Questionnaire (BAFT)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)(Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Quality of Life Inventory (QOLI)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))
  • Work and Social Adjustment Scale (WSAS)(Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention))

Study Sites (1)

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