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Online Acceptance and Commitment Therapy for Reducing Anxiety

Primary Purpose

Anxiety Disorder/Anxiety State

Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
ACT program
Sponsored by
West University of Timisoara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder/Anxiety State focused on measuring Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • West University of Timisoara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT program

Wait-list control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
The 15 item BMEAQ was developed to measure the tendency to avoid negative internal experiences .
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.
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.

Full Information

First Posted
February 28, 2017
Last Updated
May 9, 2017
Sponsor
West University of Timisoara
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1. Study Identification

Unique Protocol Identification Number
NCT03074669
Brief Title
Online Acceptance and Commitment Therapy for Reducing Anxiety
Official Title
Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
May 15, 2017 (Anticipated)
Study Completion Date
January 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West University of Timisoara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder/Anxiety State
Keywords
Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACT program
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACT program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Social Phobia Inventory (SPIN)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Panic Disorder Severity Scale - Self Report (PDSS-SR)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual-5 (PCL-5)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
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.
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
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
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)]
Title
Acceptance and Action Questionnaire 2 (AAQ2)
Description
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.
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Mindful Attention Awareness Scale (MAAS)
Description
The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Higher scores reflect higher levels of dispositional mindfulness.
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Believability of Anxious Feelings and Thoughts Questionnaire (BAFT)
Description
The BAFT is a 16 item measure of cognitive fusion with anxious thoughts and feelings. Scores range from 16 to 112.
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Brief Multidimensional Experiential Avoidance Questionnaire (BMEAQ)
Description
The 15 item BMEAQ was developed to measure the tendency to avoid negative internal experiences .
Time Frame
Pre-intervention, week 2, week 4, week 6, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Quality of Life Inventory (QOLI)
Description
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.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Title
Work and Social Adjustment Scale (WSAS)
Description
The WSAS measures impaired functioning.The maximum score of the WSAS is 40 with lower scores suggesting better functioning.
Time Frame
Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, PhD
Organizational Affiliation
West University of Timisoara
Official's Role
Principal Investigator
Facility Information:
Facility Name
West University of Timisoara
City
Timișoara
State/Province
Timiș
ZIP/Postal Code
300223
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be process only at the group level. No individual data will be shared to third parties.

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Online Acceptance and Commitment Therapy for Reducing Anxiety

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