Generalized Anxiety DisorderNCT03709433
Open Trial of an ACT Skills Group and Mobile App for Worry
A study testing ACT groups and mobile app in people with Generalized Anxiety Disorder, run by Utah State University at 1 site in United States.
Trial summary
This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD. Study hypotheses are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- ACT groups and mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 15 Apr 2020
- 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
- Seeking treatment for worry
- Fluent in English
- At least 18 years old
- Have no serious mental illness
- Not currently receiving other treatment
- Meeting diagnostic criteria for generalized anxiety disorder
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An ACT Skills Group and Mobile App for Worry
This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD.
Study hypotheses are:
- Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
- Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
- Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.
Read the detailed description
Participants and power:
Each group will include 6-12 participants. The target sample size is 36 participants, which would provide good power (0.90) to detect a medium effect size in a repeated-measures ANOVA with three time points and requires running at least 3 groups.
All clinics on the Utah State University campus will be asked to refer their waitlist clients to the group, if appropriate (e.g., client presented with significant worry). Local private practitioners in the Cache Valley, Utah area may also be notified about the option to refer their waitlist clients to the group. Fliers will be posted on the Utah State University campus and in the local community and distributed to providers to provide more information on the study. Fliers will direct interested individuals to contact the researchers. The study will also be listed on the Utah State University Contextual Behavioral Science Lab website with a link to the pre-screening.
Procedures:
Individuals who contact the researchers expressing interest will be sent more information on study procedures and asked to complete a brief online pre-screening specific to this study.
If potential participants are likely to be eligible based on the online pre-screening, they will be asked to schedule an initial assessment. They will be asked to review a consent form and given an opportunity to ask any questions. Those who decide to participate and sign the consent form will be administered the MINI International Neuropsychiatric Interview to check eligibility (i.e., GAD diagnosis, no serious mental illness), then asked to complete a series of self-report measures hosted on Qualtrics on an iPad to establish a baseline.
The group intervention will begin when the groups are filled. There will be no cost or compensation for participating in the groups. They will be facilitated by two doctoral students with training in ACT. Participants will be informed about and trained in using the ACT Daily mobile app at the first group and reminded about how to use it at each weekly group. Reminders about using the app will also be sent weekly through email or text to participants in the follow-up period.
Participants will be asked to complete a credibility questionnaire on paper at the end of the first session. They will be asked to complete an online post-treatment survey after the group sessions conclude, and a final online follow-up survey one month later.
Intervention:
The group therapy intervention consists of six weekly sessions of acceptance and commitment therapy (ACT). Each session will be two hours long. The intervention was developed based on established ACT protocols and adapted to fit the group format and generalized anxiety. The intervention uses metaphors, experiential exercises, and discussion to target the core elements of ACT: acceptance, defusion, present moment awareness, self-as-context, values, and committed action. Groups will be closed (i.e. new group members will not be added as sessions progress). Sessions will be video recorded for the purposes of training and supervision and to allow for a review of treatment fidelity.
The ACT Daily mobile app is hosted on Qualtrics and teaches a variety of ACT skills targeting acceptance, defusion, present moment awareness, values, and committed action. Users will answer some brief questions regarding their current symptoms and psychological flexibility and then be recommended a tailored skill relevant to the psychological flexibility process that they report struggling with the most in the moment.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- ACT groups and mobile app
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT groups and mobile appBehavioural
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| ACT groups and mobile app | Experimental | Participants will receive six two-hour weekly sessions of acceptance and commitment therapy (ACT) in a group format. They will also access the ACT Daily mobile app, which helps participants practice ACT skills in the moment, for the duration of the study (10-14 weeks depending on when the participant completes the baseline assessment.) Sessions use metaphors, experiential exercises, and discussion to target core ACT skills: acceptance, defusion, present-moment awareness, self-as-context, values, and committed action. The mobile app includes metaphors and experiential exercises to aid with all of these skills except self-as-context. Participants will be asked to use the app to practice these skills and to complete behavioral commitments linked to their values between sessions. Receives: Behavioral: ACT groups and mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
Measured: At posttreatment (6-10 weeks after baseline)
Secondary outcomes (27)
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
Measured: At posttreatment (6-10 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity.
Measured: At posttreatment (6-10 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity in clinical samples.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
Measured: At posttreatment (6-10 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
Measured: At posttreatment (6-10 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
Measured: At posttreatment (6-10 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
Measured: At posttreatment (6-10 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
Measured: At posttreatment (6-10 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
Measured: At posttreatment (6-10 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
Measured: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Credibility/Expectancy Questionnaire (CEQ)
The CEQ is a 6-item measure of the credibility of a treatment approach and expectations of treatment outcomes. This measure has good reliability.
Measured: At the end of the first group therapy session, 0-4 weeks after baseline
Mobile app question: "How much are you....Feeling nervous, anxious, or on edge"
This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Worrying too much about different things"
This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Feeling down, depressed, or hopeless"
This item was taken from the PHQ-9, a well-validated measure of depression. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Fighting your feelings"
This item assesses momentary experiential avoidance. It is lacking full validation but has been used successfully in previous mobile app research.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Stuck in thoughts"
This item assesses momentary cognitive fusion. It is lacking full validation but has been used successfully in previous mobile app research.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Running on autopilot"
This item assesses momentary inattention. It is lacking full validation but has been used successfully in previous mobile app research.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Disconnected from values"
This item assesses momentary values obstruction. It is lacking full validation but has been used successfully in previous mobile app research.
Measured: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Treatment Evaluation Inventory-Short Form (TEI-SF)
The TEI-SF is a 9-item measure of treatment acceptability. In this study two items were omitted and others were revised to be appropriate for the present sample. This measure has good reliability and has been demonstrated to discriminate between different treatments.
Measured: At posttreatment (6-10 weeks after baseline)
Novel satisfaction items
13 novel items were developed assessing satisfaction with the intervention (both overall and for specific components).
Measured: At posttreatment (6-10 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start17 Sep 2018
- Primary completion21 Mar 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Twohig, Ph.D., Utah State University
- Investigators
- Michael Twohig, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709433
- Sponsor's protocol ID
- 9528
- Status last verified
- Jun 2020
- First submitted
- 9 Oct 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fleming, J. E., & Kocovski, N. L. (2014). MINDFULNESS AND ACCEPTANCE-BASED GROUP THERAPY FOR SOCIAL ANXIETY DISORDER: A Treatment Manual (2nd ed.). Retrieved from https://contextualscience.org/mindfulness_and_acceptancebased_group_therapy_for_1
Boone, M. S., & Cannici, J. (2013). Acceptance and commitment therapy (ACT) in groups. In Pistorello, J., (Ed.). Acceptance and mindfulness for counseling college students: Theory and practical applications for intervention, prevention, and outreach. Oakland, CA: New Harbinger.
Twohig, M. (2004). ACT for OCD: Abbreviated Treatment Manual. (Unpublished treatment protocol). University of Nevada, Reno.
Hayes, S. C., Strosahl, K., & Wilson, K. G. (2012). Acceptance and Commitment Therapy, Second Edition: The Process and Practice of Mindful Change. New York: Guilford Press.
Levin, M.E., Haeger, J. & Cruz, R.A. (In Press). Tailoring acceptance and commitment therapy skill coaching in-the-moment through smartphones: Results from a randomized controlled trial. Mindfulness.
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
PubMed 2076086Molina, S., & Borkovec, T. D. (1994). The Penn State Worry Questionnaire: Psychometric properties and associated characteristics. In G. C. L. Davey & F. Tallis (Eds.), Wiley series in clinical psychology. Worrying: Perspectives on theory, assessment and treatment (pp. 265-283). Oxford, England: John Wiley & Sons.
Spielberger, C. D. (1983). State-Trait Anxiety Inventory (Form Y). Redwood City, CA: Mind Garden.
Segal DL, Coolidge FL, Cahill BS, O'Riley AA. Psychometric properties of the Beck Depression Inventory II (BDI-II) among community-dwelling older adults. Behav Modif. 2008 Jan;32(1):3-20. doi: 10.1177/0145445507303833.
PubMed 18096969Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
PubMed 22035996Herzberg KN, Sheppard SC, Forsyth JP, Crede M, Earleywine M, Eifert GH. The Believability of Anxious Feelings and Thoughts Questionnaire (BAFT): a psychometric evaluation of cognitive fusion in a nonclinical and highly anxious community sample. Psychol Assess. 2012 Dec;24(4):877-91. doi: 10.1037/a0027782. Epub 2012 Apr 9.
PubMed 22486595Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172.
Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.
PubMed 24447188Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.
PubMed 20973032
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ACT Skills Group and Mobile App for Worry
- ClinicalTrials.gov ID
- NCT03709433
- Acronym / sponsor ID
- 9528
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 17 Oct 2018 (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.
This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD.
Study hypotheses are:
- Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
- Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
- Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.
Detailed description
Participants and power:
Each group will include 6-12 participants. The target sample size is 36 participants, which would provide good power (0.90) to detect a medium effect size in a repeated-measures ANOVA with three time points and requires running at least 3 groups.
All clinics on the Utah State University campus will be asked to refer their waitlist clients to the group, if appropriate (e.g., client presented with significant worry). Local private practitioners in the Cache Valley, Utah area may also be notified about the option to refer their waitlist clients to the group. Fliers will be posted on the Utah State University campus and in the local community and distributed to providers to provide more information on the study. Fliers will direct interested individuals to contact the researchers. The study will also be listed on the Utah State University Contextual Behavioral Science Lab website with a link to the pre-screening.
Procedures:
Individuals who contact the researchers expressing interest will be sent more information on study procedures and asked to complete a brief online pre-screening specific to this study.
If potential participants are likely to be eligible based on the online pre-screening, they will be asked to schedule an initial assessment. They will be asked to review a consent form and given an opportunity to ask any questions. Those who decide to participate and sign the consent form will be administered the MINI International Neuropsychiatric Interview to check eligibility (i.e., GAD diagnosis, no serious mental illness), then asked to complete a series of self-report measures hosted on Qualtrics on an iPad to establish a baseline.
The group intervention will begin when the groups are filled. There will be no cost or compensation for participating in the groups. They will be facilitated by two doctoral students with training in ACT. Participants will be informed about and trained in using the ACT Daily mobile app at the first group and reminded about how to use it at each weekly group. Reminders about using the app will also be sent weekly through email or text to participants in the follow-up period.
Participants will be asked to complete a credibility questionnaire on paper at the end of the first session. They will be asked to complete an online post-treatment survey after the group sessions conclude, and a final online follow-up survey one month later.
Intervention:
The group therapy intervention consists of six weekly sessions of acceptance and commitment therapy (ACT). Each session will be two hours long. The intervention was developed based on established ACT protocols and adapted to fit the group format and generalized anxiety. The intervention uses metaphors, experiential exercises, and discussion to target the core elements of ACT: acceptance, defusion, present moment awareness, self-as-context, values, and committed action. Groups will be closed (i.e. new group members will not be added as sessions progress). Sessions will be video recorded for the purposes of training and supervision and to allow for a review of treatment fidelity.
The ACT Daily mobile app is hosted on Qualtrics and teaches a variety of ACT skills targeting acceptance, defusion, present moment awareness, values, and committed action. Users will answer some brief questions regarding their current symptoms and psychological flexibility and then be recommended a tailored skill relevant to the psychological flexibility process that they report struggling with the most in the moment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
| Arm | Type | Receives |
|---|---|---|
| ACT groups and mobile app | Experimental | Behavioral: ACT groups and mobile appParticipants will receive six two-hour weekly sessions of acceptance and commitment therapy (ACT) in a group format. They will also access the ACT Daily mobile app, which helps participants practice ACT skills in the moment, for the duration of the study (10-14 weeks depending on when the participant completes the baseline assessment.) Sessions use metaphors, experiential exercises, and discussion to target core ACT skills: acceptance, defusion, present-moment awareness, self-as-context, values, and committed action. The mobile app includes metaphors and experiential exercises to aid with all of these skills except self-as-context. Participants will be asked to use the app to practice these skills and to complete behavioral commitments linked to their values between sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Seeking treatment for worry
- Fluent in English
- At least 18 years old
- Have no serious mental illness
- Not currently receiving other treatment
Key exclusion criteria (0 listed)
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 groups and mobile appSee arm description. | Behavioural | ACT groups and mobile app |
Primary outcome
Penn State Worry Questionnaire (PSWQ)
Time frame: At posttreatment (6-10 weeks after baseline)
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
27 secondary outcomes
Penn State Worry Questionnaire (PSWQ)
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
Time frame: At posttreatment (6-10 weeks after baseline)
State-Trait Anxiety Inventory (STAI) - Trait Subscale
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
Time frame: At posttreatment (6-10 weeks after baseline)
Beck Depression Inventory-II (BDI-II)
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
Time frame: At posttreatment (6-10 weeks after baseline)
Acceptance and Action Questionnaire (AAQ-II)
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
Time frame: At posttreatment (6-10 weeks after baseline)
Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
Time frame: At posttreatment (6-10 weeks after baseline)
Mindful Attention Awareness Scale (MAAS)
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
Time frame: At posttreatment (6-10 weeks after baseline)
Valuing Questionnaire (VQ) - Progress subscale
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
Time frame: At posttreatment (6-10 weeks after baseline)
PROMIS 8a Satisfaction with Social Roles and Activities
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
Time frame: At posttreatment (6-10 weeks after baseline)
Mental Health Continuum-Short Form (MHC-SF)
Time frame: One month after the posttreatment survey is administered (10-14 weeks after baseline)
Credibility/Expectancy Questionnaire (CEQ)
Time frame: At the end of the first group therapy session, 0-4 weeks after baseline
Mobile app question: "How much are you....Feeling nervous, anxious, or on edge"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Worrying too much about different things"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Feeling down, depressed, or hopeless"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Fighting your feelings"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Stuck in thoughts"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Running on autopilot"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Mobile app question: "How much are you....Disconnected from values"
Time frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.
Treatment Evaluation Inventory-Short Form (TEI-SF)
Time frame: At posttreatment (6-10 weeks after baseline)
Novel satisfaction items
Time frame: At posttreatment (6-10 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- BackgroundFleming, J. E., & Kocovski, N. L. (2014). MINDFULNESS AND ACCEPTANCE-BASED GROUP THERAPY FOR SOCIAL ANXIETY DISORDER: A Treatment Manual (2nd ed.). Retrieved from https://contextualscience.org/mindfulness_and_acceptancebased_group_therapy_for_1
- BackgroundBoone, M. S., & Cannici, J. (2013). Acceptance and commitment therapy (ACT) in groups. In Pistorello, J., (Ed.). Acceptance and mindfulness for counseling college students: Theory and practical applications for intervention, prevention, and outreach. Oakland, CA: New Harbinger.
- BackgroundTwohig, M. (2004). ACT for OCD: Abbreviated Treatment Manual. (Unpublished treatment protocol). University of Nevada, Reno.
- BackgroundHayes, S. C., Strosahl, K., & Wilson, K. G. (2012). Acceptance and Commitment Therapy, Second Edition: The Process and Practice of Mindful Change. New York: Guilford Press.
- BackgroundLevin, M.E., Haeger, J. & Cruz, R.A. (In Press). Tailoring acceptance and commitment therapy skill coaching in-the-moment through smartphones: Results from a randomized controlled trial. Mindfulness.
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- Individual participant dataSharing planned: No
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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.
Michael Twohig, PhD principal investigator
Utah State University
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 groups and mobile app in people with Generalized Anxiety Disorder, run by Utah State University at 1 site in United States.
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 6 inclusion and 0 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: finished, as of the sponsor's last update on 9 Jun 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Penn State Worry Questionnaire (PSWQ) (time frame: At posttreatment (6-10 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709433, which also lists 17 linked publications.
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 9 Jun 2020.