Clinical trial NCT03074669: Online Acceptance and Commitment Therapy for Reducing Anxiety
Official title: Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorder/Anxiety State
Keywords: Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)
Lead sponsor: West University of Timisoara
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Changes in Anxiety Sensitivity Index (ASI)
timeFrame: Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)
Secondary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Social Phobia Inventory (SPIN)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Panic Disorder Severity Scale - Self Report (PDSS-SR)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
measure: Acceptance and Action Questionnaire 2 (AAQ2)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Believability of Anxious Feelings and Thoughts Questionnaire (BAFT)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
timeFrame: Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Quality of Life Inventory (QOLI)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Other outcomes:
Locations:
city: Timișoara
country: Romania
facility: West University of Timisoara
state: Timiș
Study officials:
affiliation: West University of Timisoara
name: Bogdan Tudor Tulbure, PhD
role: PRINCIPAL_INVESTIGATOR
References: