Online Acceptance and Commitment Therapy for Reducing Anxiety

NCT03074669 | Unknown

• 1 other identifier: WUTimisoara ACT-online
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder/Anxiety State

Keywords

Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)

Outcome Measures

Primary Outcomes (1)

• Changes in Anxiety Sensitivity Index (ASI)

  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.

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

Secondary Outcomes (14)

• 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)

Study Arms (2)

ACT program

EXPERIMENTAL

Participants from the active treatment group will be granted access to seven modules that are structured like chapters of a self-help book adapted for the online environment. In addition, participants from the experimental arm will be guided by an on-line therapist throughout the program duration. The on-line therapists are graduate students in clinical psychology who work under the supervision of an experienced psychotherapist. Participants will be asked to fill in a series of self-report measures to monitor their anxiety and some ACT specific processes (i.e., acceptance, mindfulness, experiential avoidance) throughout the intervention.

Behavioral: ACT program

Wait-list control group

NO INTERVENTION

During the first seven weeks, participants in the wait-list control group will only be asked to fill in a series of self-report measures to monitor their anxiety and some ACT specific processes (i.e., acceptance, mindfulness, experiential avoidance). Following the experimental group's completion of the program, participants in this group will also receive the intervention. All participants will be contacted 6 months after the intervention has concluded in order to conduct a follow-up assessment.

Interventions

ACT program BEHAVIORAL

ACT program consists of seven modules that have been adapted for the online environment. Each module is structured like a therapy session with at least two homework assignments.

ACT program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West University of Timisoara: lead

Study Sites (1)

West University of Timisoara

Timișoara, Timiș County, 300223, Romania

Location

MeSH Terms

Conditions

Anxiety Disorders; Disease; Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Bogdan Tudor Tulbure, PhD

  West University of Timisoara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: March 15, 2017
• Primary Completion: May 15, 2017
• Study Completion: January 30, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)