Online Acceptance and Commitment Therapy for Reducing Anxiety

Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorder/Anxiety State
• Intervention / Treatment: Behavioral: ACT program

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timiș
    • Timișoara, Timiș, Romania, 300223
      • West University of Timisoara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT program; 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; 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.
No Intervention: Wait-list control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penn State Worry Questionnaire (PSWQ)	The PSWQ was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score rages from 16 to 80. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Social Phobia Inventory (SPIN)	The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score rages from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Yale-Brown Obsessive Compulsive Scale (YBOCS)	The YBOCS was designed to measure participant's level of obsessions and compulsions (O&C). The scale total score rages from 0 to 40. Low scores are associated with low levels of O&C, while high scores are associated with high levels of O&C.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Panic Disorder Severity Scale - Self Report (PDSS-SR)	The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.	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)	The PCL-5 was designed to measure participant's level of post-traumatic stress. The scale is unidimensional and the total score rages from 0 to 80. Low scores are associated with low levels of post-traumatic stress, while high scores are associated with high levels of post-traumatic stress.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Beck Depression Inventory-II (BDI-II)	The BDI-II was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Overall Anxiety Severity and Impairment Scale (OASIS)	The OASIS was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.	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)	The ODSIS was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 20. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression	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)	The AAQ2 was designed to measure of ACT's model of mental health and behavioral effectiveness. Scores range from 7 to 49 points, with high scores indicating greater experiential avoidance and immobility.	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)	The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Higher scores reflect higher levels of dispositional mindfulness.	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)	The BAFT is a 16 item measure of cognitive fusion with anxious thoughts and feelings. Scores range from 16 to 112.	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)	The 15 item BMEAQ was developed to measure the tendency to avoid negative internal experiences .	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)	The QOLI assesses an individual's quality of life through self-report of the importance they attach to each of 16 life domains. Each item is rated twice according to a) the importance to the overall happiness and satisfaction (0 = not at all important, 1 = important, 2 = extremely important) and b) satisfaction with the area ( -3 = very dissatisfied to +3 = very satisfied). The QOLI is a unidimensional scale with a continuous score that rages from -6 to +6, with negative score indicating a low life quality and the positive score indicating a high life quality.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Work and Social Adjustment Scale (WSAS)	The WSAS measures impaired functioning.The maximum score of the WSAS is 40 with lower scores suggesting better functioning.	Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)

Collaborators and Investigators

• Sponsor: West University of Timisoara
• Investigators: Principal Investigator: Bogdan Tudor Tulbure, PhD, West University of Timisoara

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Anticipated): May 15, 2017
• Study Completion (Anticipated): January 30, 2018

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: WUTimisoara ACT-online

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be process only at the group level. No individual data will be shared to third parties.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No