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Open Trial of an ACT Skills Group and Mobile App for Worry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709433
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Twohig, Ph.D., Utah State University

Brief 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. Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
  2. Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
  3. Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: ACT groups and mobile app Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
Masking: None (Open Label)
Masking Description: No masking will be used.
Primary Purpose: Treatment
Official Title: An ACT Skills Group and Mobile App for Worry
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : March 21, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: ACT groups and mobile app
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.
Behavioral: ACT groups and mobile app
See arm description.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Penn State Worry Questionnaire (PSWQ) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.

  2. State-Trait Anxiety Inventory (STAI) - Trait Subscale [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.

  3. State-Trait Anxiety Inventory (STAI) - Trait Subscale [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.

  4. Beck Depression Inventory-II (BDI-II) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity.

  5. Beck Depression Inventory-II (BDI-II) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity in clinical samples.

  6. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.

  7. Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.

  8. Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.

  9. Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.

  10. Mindful Attention Awareness Scale (MAAS) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    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.

  11. Mindful Attention Awareness Scale (MAAS) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    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.

  12. Valuing Questionnaire (VQ) - Progress subscale [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    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.

  13. Valuing Questionnaire (VQ) - Progress subscale [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    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.

  14. PROMIS 8a Satisfaction with Social Roles and Activities [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    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.

  15. PROMIS 8a Satisfaction with Social Roles and Activities [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    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.

  16. Mental Health Continuum-Short Form (MHC-SF) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.

  17. Mental Health Continuum-Short Form (MHC-SF) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.

  18. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: At the end of the first group therapy session, 0-4 weeks after baseline ]
    The CEQ is a 6-item measure of the credibility of a treatment approach and expectations of treatment outcomes. This measure has good reliability.

  19. 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. ]
    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.

  20. 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. ]
    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.

  21. 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. ]
    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.

  22. 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. ]
    This item assesses momentary experiential avoidance. It is lacking full validation but has been used successfully in previous mobile app research.

  23. 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. ]
    This item assesses momentary cognitive fusion. It is lacking full validation but has been used successfully in previous mobile app research.

  24. 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. ]
    This item assesses momentary inattention. It is lacking full validation but has been used successfully in previous mobile app research.

  25. 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. ]
    This item assesses momentary values obstruction. It is lacking full validation but has been used successfully in previous mobile app research.

  26. Treatment Evaluation Inventory-Short Form (TEI-SF) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    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.

  27. Novel satisfaction items [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    13 novel items were developed assessing satisfaction with the intervention (both overall and for specific components).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Seeking treatment for worry
  2. Fluent in English
  3. At least 18 years old
  4. Have no serious mental illness
  5. Not currently receiving other treatment
  6. Meeting diagnostic criteria for generalized anxiety disorder

Exclusion criteria mirror inclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709433


Locations
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United States, Utah
Utah State University
Logan, Utah, United States, 84322
Sponsors and Collaborators
Utah State University
Investigators
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Principal Investigator: Michael Twohig, PhD Utah State University
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.
Molina, 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.
Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172.
Kelley, M. L., Heffer, R. W., Gresham, F. M., & Elliot, S. N. (1989). Development of a modified Treatment Evaluation Inventory. Journal of Psychopathology and Behavioral Assessment, 11, 235-247. doi:10.1007/BF00960495

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Responsible Party: Michael Twohig, Ph.D., Professor, Utah State University
ClinicalTrials.gov Identifier: NCT03709433    
Other Study ID Numbers: 9528
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders