Open Trial of an ACT Skills Group and Mobile App for Worry
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2018 |
| Start Date: | September 17, 2018 |
| End Date: | August 2020 |
| Contact: | Jennifer Krafft, BA |
| Email: | jennifer.krafft@aggiemail.usu.edu |
| Phone: | 4359320291 |
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:
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.
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.
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.
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.
We found this trial at
1
site
Logan, Utah 84322
Principal Investigator: Michael P Twohig, Ph.D.
Phone: 435-265-8933
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