Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03709433
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Trial of an ACT Skills Group and Mobile App for Worry
Sponsor:
Utah State University
Organization:
Study Overview
Official Title:
An ACT Skills Group and Mobile App for Worry
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: