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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An ACT Skills Group and Mobile App for Worry

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: ACT groups and mobile app


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria mirror inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT groups and mobile app<br>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<br>* See arm description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At posttreatment (6-10 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | At posttreatment (6-10 weeks after baseline) |