Online Acceptance and Commitment Therapy for Reducing Anxiety

Anxiety Disorder/Anxiety State Clinical Trial

Official title:

Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03074669
• Other study ID #: WUTimisoara ACT-online
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2017
• Last updated: May 9, 2017
• Start date: March 15, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: May 2017
• Source: West University of Timisoara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 30, 2018
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorder/Anxiety State
• Anxiety Disorders

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.

Locations

Country	Name	City	State
Romania	West University of Timisoara	Timi?oara	Timi?

Sponsors (1)

Lead Sponsor	Collaborator
West University of Timisoara

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)]
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)