Psychological DistressPhase 1CompACTNCT04081662
Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students
A Phase 1 study testing compACT Intervention in people with Psychological Distress and Self-Assessment, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research study aims to evaluate the feasibility, safety, and effectiveness of a micro-randomized acceptance and commitment therapy-based (ACT-based) intervention that is delivered to distressed first-generation college students. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Self-Assessment, Mood Change
- What is being tested?
- compACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to 11 May 2021
- Phase
- Phase 1
- 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 to 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to provide informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Individuals 18-19 years of age.
- Individuals who are full-time freshman or sophomore students at the University of Wisconsin-Madison.
- Fluent in written English.
- Has access to a smartphone.
- First-generation college student.
- Significant subjective distress (endorses distress on at least 4 out of the past 7 days that interfered with functioning in screening survey).
Who cannot join
- Expected life expectancy <6 months.
- Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
This research study aims to evaluate the feasibility, safety, and effectiveness of a micro-randomized acceptance and commitment therapy-based (ACT-based) intervention that is delivered to distressed first-generation college students.
Read the detailed description
The transition to college is associated with a number of changes in health behaviors and mental health functioning, with 50% of college students meeting criteria for a psychiatric disorder. In particular, first-generation college students may be at particular risk for increased stress and mental health difficulties. The development of effective psychotherapeutic interventions is essential in providing adequate care to young adults during the transitional years of college. Delivery of these interventions via acceptable and feasible modalities for this population is also of utmost importance so that utilization and engagement are prioritized. Brief interventions have been a point of emphasis in recent years from the perspective of patient and provider efficiency, as well as many studies indicating effectiveness of brief interventions in creating and sustaining clinical levels of change.
The current study seeks to evaluate the effectiveness of brief interventions delivered via a smartphone app, or "microinterventions", based in Acceptance and Commitment Therapy (ACT). ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. ACT is transdiagnostic, meaning that it is designed to target human suffering, rather than a particular psychological or physical disorder. ACT targets experiential avoidance, which is the inability or unwillingness to make contact with painful experiences (e.g., thoughts, emotions, memories. Avoidance provides short-term relief, but exacerbates the long-term experience of the avoided stimulus in terms of intensity and duration. The microintervention in this study will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT. For example, one prompt is "Do your current actions align with what matters most to you?" Delivery of these prompts (e.g., whether and when to deliver which prompt) is randomized to allow for secondary analyses of optimal delivery of the microintervention in addition to primary analyses of its effectiveness.
- Conditions
- Psychological Distress, Self-Assessment, Mood Change
- Being tested
- compACT Intervention
- Keywords
- Acceptance and commitment therapy, Micro-intervention, Mobile intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compACT InterventionBehavioural
The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.
Self-monitoring: twice daily, participants will complete self-reports of distress, depressive symptoms, and activity through the mobile app Lorevimo.
Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
| Study group | Role | What they receive |
|---|---|---|
| compACT Intervention | Experimental | At every time-point of the study, participants will complete self-reports of stress, (as measured by the PSS-4) distress (as measured by the PHQ-2), and activity through the mobile app Lorevimo. After completing these assessments, participants will be randomly assigned to either receive one additional ACT-based microintervention question or receive no additional question.
The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action).
The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. Receives: Behavioral: compACT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts
The feasibility of the microintervention will be assessed by Adherence to prompts (defined as a response to at least 50% completion of prompt items per day). If subjects adhere to prompts over 60% of the days of the intervention period on average, the intervention will be considered feasible. The prompts considered will be the 2 questions from the PHQ-2, the 4 questions from the PSS-4, and the 4 questions from the activity assessment.
Measured: Day 1 - day 43
Safety of ACT micro-intervention: Change in Patient Health Questionnaire 9 (PHQ-9)
The analysis will look at the change in proportion of individuals who meet criteria for minor or major depression on the PHQ-9 between study start (measure taken at baseline assessment) to study end (measure taken at 6-month follow-up assessment).
The Patient Health Questionnaire 9 (PHQ-9) is a multipurpose scale for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 will reflect the effect of intervention on the severity of depression. The PHQ-9 scores correlates with the depression severity as follows:
5 to 9- Minimal symptoms 10 to 14- Minor depression 15 to 19 Major depression, moderately severe >20 Major depression, severe
Measured: Baseline, 3 months and 6 months post intervention
Effectiveness of the ACT micro-intervention: proximal changes in mood outcomes as a result of intervention as indicated by self-reported activity of participant
The effectiveness of the ACT micro-intervention will be assessed by looking at the responses to the activity assessment in relation to whether or not a participant received a micro-intervention at the prior time-point. The activity questions of interest are as follows:
- Since you [woke this morning or last logged your symptoms], how much energy was consumed by trying to get rid of unwanted feelings, thoughts, or other internal experiences (example: suppressing, distracting, avoiding)?
- Since you [woke this morning or last logged your symptoms], how much energy was consumed by pursuing your values (example: making choices that align with who you want to be or who/what matters)?
Both questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy."
Measured: Days 1-43
Secondary outcomes (2)
Proximal changes in mood outcomes as a result of intervention: The Perceived Stress Scale (PSS-4) score
The effectiveness of the ACT micro-intervention will be assessed by looking at the PSS-4 score in relation to whether or not a participant received a micro-intervention at the prior time-point.
The Perceived Stress Scale (PSS-4) consists of four questions, each answered using a scale of 0-4. The total PSS-4 score ranges from 0-16. A higher score indicates a higher degree and/or longer duration of perceived stress.
Measured: Days 1-43
Proximal changes in mood outcomes as a result of intervention: Patient Health Questionnaire-2 (PHQ-2) score
The effectiveness of the ACT micro-intervention will be assessed by looking at PHQ-2 score in relation to whether or not a participant received a micro-intervention at the prior time-point. The PHQ-2 consists of the first two questions of the Patient Health Questionnaire-9 (PHQ-9) and asks about the frequency of depressed mood and anhedonia over the past two weeks. Each question is answered on a scale of 0-3 as follows:
0 = Not at all
- = Several days
- = More than half the days
- = Nearly every day
The PHQ-2 score ranges from 0-6, with a score of 0-2 being negative for potential major depressive disorder and a score of 3 or more being positive for potential major depressive disorder.
Measured: Days 1-43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start18 Oct 2019
- Primary completion20 Nov 2020
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study). For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081662
- Sponsor's protocol ID
- 2019-0819
- Other IDs
- Biostat & Med, A538900, SMPH/PSYCHIATRY/PSYCHIATRY
- Acronym
- CompACT
- Status last verified
- Aug 2021
- First submitted
- 4 Sep 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas EBK, Sagorac Gruichich T, Maronge JM, Hoel S, Victory A, Stowe ZN, Cochran A. Mobile Acceptance and Commitment Therapy With Distressed First-Generation College Students: Microrandomized Trial. JMIR Ment Health. 2023 May 15;10:e43065. doi: 10.2196/43065.
PubMed 37184896Kroska EB, Hoel S, Victory A, Murphy SA, McInnis MG, Stowe ZN, Cochran A. Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials. JMIR Res Protoc. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086.
PubMed 32965227
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students
- ClinicalTrials.gov ID
- NCT04081662
- Acronym / sponsor ID
- CompACT / 2019-0819
- Conditions
- Psychological Distress, Self-Assessment, Mood Change
- Keywords
- Acceptance and commitment therapy, Micro-intervention, Mobile intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 9 Sep 2019 (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 research study aims to evaluate the feasibility, safety, and effectiveness of a micro-randomized acceptance and commitment therapy-based (ACT-based) intervention that is delivered to distressed first-generation college students.
Detailed description
The transition to college is associated with a number of changes in health behaviors and mental health functioning, with 50% of college students meeting criteria for a psychiatric disorder. In particular, first-generation college students may be at particular risk for increased stress and mental health difficulties. The development of effective psychotherapeutic interventions is essential in providing adequate care to young adults during the transitional years of college. Delivery of these interventions via acceptable and feasible modalities for this population is also of utmost importance so that utilization and engagement are prioritized. Brief interventions have been a point of emphasis in recent years from the perspective of patient and provider efficiency, as well as many studies indicating effectiveness of brief interventions in creating and sustaining clinical levels of change.
The current study seeks to evaluate the effectiveness of brief interventions delivered via a smartphone app, or "microinterventions", based in Acceptance and Commitment Therapy (ACT). ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. ACT is transdiagnostic, meaning that it is designed to target human suffering, rather than a particular psychological or physical disorder. ACT targets experiential avoidance, which is the inability or unwillingness to make contact with painful experiences (e.g., thoughts, emotions, memories. Avoidance provides short-term relief, but exacerbates the long-term experience of the avoided stimulus in terms of intensity and duration. The microintervention in this study will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT. For example, one prompt is "Do your current actions align with what matters most to you?" Delivery of these prompts (e.g., whether and when to deliver which prompt) is randomized to allow for secondary analyses of optimal delivery of the microintervention in addition to primary analyses of its effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study). For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.
| Arm | Type | Receives |
|---|---|---|
| compACT Intervention | Experimental | Behavioral: compACT InterventionAt every time-point of the study, participants will complete self-reports of stress, (as measured by the PSS-4) distress (as measured by the PHQ-2), and activity through the mobile app Lorevimo. After completing these assessments, participants will be randomly assigned to either receive one additional ACT-based microintervention question or receive no additional question. The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing to provide informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Individuals 18-19 years of age.
- Individuals who are full-time freshman or sophomore students at the University of Wisconsin-Madison.
- Fluent in written English.
Key exclusion criteria (3 listed)
- Expected life expectancy <6 months.
- Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
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 |
|---|---|---|
| compACT InterventionThe mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of distress, depressive symptoms, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments. | Behavioural | compACT Intervention |
Primary outcome
Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts
Time frame: Day 1 - day 43
The feasibility of the microintervention will be assessed by Adherence to prompts (defined as a response to at least 50% completion of prompt items per day). If subjects adhere to prompts over 60% of the days of the intervention period on average, the intervention will be considered feasible. The prompts considered will be the 2 questions from the PHQ-2, the 4 questions from the PSS-4, and the 4 questions from the activity assessment.
Safety of ACT micro-intervention: Change in Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline, 3 months and 6 months post intervention
The analysis will look at the change in proportion of individuals who meet criteria for minor or major depression on the PHQ-9 between study start (measure taken at baseline assessment) to study end (measure taken at 6-month follow-up assessment). The Patient Health Questionnaire 9 (PHQ-9) is a multipurpose scale for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 will reflect the effect of intervention on the severity of depression. The PHQ-9 scores correlates with the depression severity as follows: 5 to 9- Minimal symptoms 10 to 14- Minor depression 15 to 19 Major depression, moderately severe >20 Major depression, severe
Effectiveness of the ACT micro-intervention: proximal changes in mood outcomes as a result of intervention as indicated by self-reported activity of participant
Time frame: Days 1-43
The effectiveness of the ACT micro-intervention will be assessed by looking at the responses to the activity assessment in relation to whether or not a participant received a micro-intervention at the prior time-point. The activity questions of interest are as follows: 1. Since you [woke this morning or last logged your symptoms], how much energy was consumed by trying to get rid of unwanted feelings, thoughts, or other internal experiences (example: suppressing, distracting, avoiding)? 2. Since you [woke this morning or last logged your symptoms], how much energy was consumed by pursuing your values (example: making choices that align with who you want to be or who/what matters)? Both questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy."
2 secondary outcomes
Proximal changes in mood outcomes as a result of intervention: The Perceived Stress Scale (PSS-4) score
Time frame: Days 1-43
Proximal changes in mood outcomes as a result of intervention: Patient Health Questionnaire-2 (PHQ-2) score
Time frame: Days 1-43
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 6 Aug 2021.
- Derived from this study: PubMed 37184896Thomas EBK, Sagorac Gruichich T, Maronge JM, Hoel S, Victory A, Stowe ZN, Cochran A. Mobile Acceptance and Commitment Therapy With Distressed First-Generation College Students: Microrandomized Trial. JMIR Ment Health. 2023 May 15;10:e43065. doi: 10.2196/43065.
- Derived from this study: PubMed 32965227Kroska EB, Hoel S, Victory A, Murphy SA, McInnis MG, Stowe ZN, Cochran A. Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials. JMIR Res Protoc. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing compACT Intervention in people with Psychological Distress and Self-Assessment, run by University of Wisconsin, Madison 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 8 inclusion and 3 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 6 Aug 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of the ACT micro-intervention: percentage adherence to PHQ-2, PSS-4, and activity prompts (time frame: Day 1 - day 43). The study lists 3 primary outcomes in all. 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 NCT04081662, which also lists 2 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 6 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.