Psychological Distress Clinical Trial
— CompACTOfficial title:
Examining the Efficacy of Acceptance and Commitment Therapy (ACT) Microinterventions for Distressed First-Generation College Students
Verified date | August 2021 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 11, 2021 |
Est. primary completion date | November 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 19 Years |
Eligibility | Inclusion Criteria: 1. Willing to provide informed consent. 2. Willing to comply with all study procedures and be available for the duration of the study. 3. Individuals 18-19 years of age. 4. Individuals who are full-time freshman or sophomore students at the University of Wisconsin-Madison. 5. Fluent in written English. 6. Has access to a smartphone. 7. First-generation college student. 8. Significant subjective distress (endorses distress on at least 4 out of the past 7 days that interfered with functioning in screening survey). Exclusion Criteria: 1. Expected life expectancy <6 months. 2. Use of investigational drugs, biologics, or devices within 30 days prior to randomization. 3. Not suitable for study participation due to other reasons at the discretion of the investigators. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 - day 43 | |
Primary | 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 |
Baseline, 3 months and 6 months post intervention | |
Primary | 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." |
Days 1-43 | |
Secondary | 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. |
Days 1-43 | |
Secondary | 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. |
Days 1-43 |
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