Anxiety Disorder/Anxiety StateNCT03074669
Online Acceptance and Commitment Therapy for Reducing Anxiety
A study testing ACT program in people with Anxiety Disorder/Anxiety State, run by West University of Timisoara at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder/Anxiety State
- What is being tested?
- ACT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 15 Mar 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be fluent in Romanian
- be over 18 years of age
- have high levels of anxiety
- have access to an Internet-connected computer
Who cannot join
- suicidal ideation
- substance abuse
- severe psychiatric disorders
- a recent change in psychotropic medication (i.e., the dose has been changed within the last month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Anxiety Disorder/Anxiety State
- Being tested
- ACT program
- Keywords
- Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)
- Medical subject headings
- Anxiety Disorders, Disease, Stress Disorders, Post-Traumatic, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start15 Mar 2017
- Primary completion15 May 2017 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder/Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bogdan Tudor Tulbure, PhD, Principal investigator, West University of Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074669
- Sponsor's protocol ID
- WUTimisoara ACT-online
- Status last verified
- May 2017
- First submitted
- 28 Feb 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be process only at the group level. No individual data will be shared to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Acceptance and Commitment Therapy for Reducing Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT03074669
- Acronym / sponsor ID
- WUTimisoara ACT-online
- Conditions
- Anxiety Disorder/Anxiety State
- Keywords
- Anxiety symptoms/disorders (OCD, PTSD, GAD, SAD, Panic)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 May 2017 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT program | Experimental | Behavioral: ACT programParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be fluent in Romanian
- be over 18 years of age
- have high levels of anxiety
- have access to an Internet-connected computer
Key exclusion criteria (4 listed)
- suicidal ideation
- substance abuse
- severe psychiatric disorders
- a recent change in psychotropic medication (i.e., the dose has been changed within the last month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT programACT 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. | Behavioural | ACT program |
Primary outcome
Changes in Anxiety Sensitivity Index (ASI)
Time frame: Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)
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.
14 secondary outcomes
Penn State Worry Questionnaire (PSWQ)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Social Phobia Inventory (SPIN)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Panic Disorder Severity Scale - Self Report (PDSS-SR)
Time frame: 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)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Beck Depression Inventory-II (BDI-II)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Work and Social Adjustment Scale (WSAS)
Time frame: Pre-intervention, Post-Intervention (7 weeks) and at Follow-up (6 month post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No. Data will be process only at the group level. No individual data will be shared to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan Tudor Tulbure, PhD principal investigator
West University of Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT program in people with Anxiety Disorder/Anxiety State, run by West University of Timisoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Anxiety Sensitivity Index (ASI) (time frame: Change from Pre- to Post-Intervention (7 weeks), and Change from Post-intervention (week 7) to Follow-up (6 month post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.