Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase II)
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|ClinicalTrials.gov Identifier: NCT02761681|
Recruitment Status : Enrolling by invitation
First Posted : May 4, 2016
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mental Health||Behavioral: ACT-CL Web-based guided self-help Behavioral: Control Web-based guided self-help||Not Applicable|
Nearly half of all college students have a diagnosable mental health problem. College counseling centers (CCCs) are faced with increasing demands for services from Universities, students, and parents to meet the treatment needs of their students, in the context of increasingly severe cases and declining resources. Innovative, cost effective solutions are needed that can improve treatment effectiveness with a range of presenting problems while reducing counselor workloads.
The current project seeks to meet these needs by building a user-informed guided self-help version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy that has been found to effectively treat a range of mental health problems by targeting experiential avoidance, the tendency to avoid unwanted emotions and negative thoughts.After the program has been built in the first stage of the study, the investigators will then test this program at several CCCs throughout the country. An ACT program would provide a means of implementing effective treatment for the range of problems encountered in the CCC setting, while the online guided self-help format would reduce counselors' workload for each client, improving cost effectiveness and reducing waiting lists. This product would both treat students through a series of self-help modules and train CCC counselors in how to implement the guided self-help ACT intervention.
For the current phase (Phase II) of this Small Business Innovation Research (SBIR) grant, 8 student self-help sessions will be developed, as well as a counselor portal with counselor training sessions to review students' use of the program and to receive training on implementing ACT guided self-help.
The current study will consist of two stages: Stage 1 will study user preferences and testing of the program as it is developed, and Stage 2 will be a randomized trial of the program in several CCCs.
Stage 1 will consist of ongoing interviews with a total of 6 students, 7 counselors and 1 director, who will be contacted intermittently throughout the program to participate in web-conference interviews in which they provide feedback on the current development, and test individual components of the program. Development will be iterative, and will be updated and adjusted based on the feedback from these focused interviews.
Stage 2 will consist of a randomized trial of 40 counselors using the program, and a nested program evaluation of 400 students (10 students per counselor). Counselors will be randomized to either the ACT on College Life program, or to a control website. After completing the condition's training, counselors will invite students to participate in the site to which the counselor has been randomized. Participants in both conditions will complete assessments at baseline, post, and follow-up. The study will examine the feasibility, efficacy, and acceptability of the program with both students and counselors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||469 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help|
|Actual Study Start Date :||April 2015|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: ACT-CL Web-based guided self-help
Behavioral: Experimental Web-based guided self-help Program This intervention will involve counselor training and student use of the developed program. Counselors will complete training and invite students to participate, and will monitor and guide students in completing the series of 8 web-based sessions based on Acceptance and Commitment Therapy.
Behavioral: ACT-CL Web-based guided self-help
Active Comparator: Control Web-based guided self-help
Behavioral: Control Web-based guided self-help program This intervention will be created for the current study. It will involve psycho-education on how students might get the most out of counseling. Counselors will go through the psycho-education session before inviting students to participate.
Behavioral: Control Web-based guided self-help
- Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62 [ Time Frame: Baseline (week 1), Post (week 8), Follow-up (week 16) ](Student Data) We will assess the change in various diagnoses and presentations common in college students (such as depression, anxiety, eating disorders, substance abuse, etc). This will be our primary outcome measure for students.
- System Usability Scale [ Time Frame: Post (week 8 or week 20) ](Counselor and Student Data) Program usability/acceptability will be a primary outcome
- ACT Knowledge Questionnaire [ Time Frame: Baseline (week 1) and post (week 20) ](Counselor Data) We will examine whether counselors improve in their knowledge of ACT concepts after going through the program to assess initial feasibility of the prototype program.
- Counselor Implementation Questions [ Time Frame: Post (week 20) ](Counselor Data) We will examine whether counselors were satisfied with the program utility, efficiency, and content and will explore the potential for subsequent dissemination of the website.
- Personal Values Questionnaire [ Time Frame: Baseline (week 1), Post (week 8) and Follow-up (week 16) ]We will examine whether students improve in their connection to and engagement in personal values after completing the program as a secondary process measure.
- Satisfaction with Life Scale [ Time Frame: Baseline (week 1), Post (week 8) and Follow-up (week 16) ]We will examine whether students improve on a measure of satisfaction with life after completing the program as a secondary outcome measure.
- Acceptance and Action Questionnaire - II [ Time Frame: Baseline (week 1), Post (week 8) and Follow-up (week 16) ]We will examine whether students improve on a measure of psychological flexibility after completing the program as a secondary process measure
- Five Facet Mindfulness Questionnaire [ Time Frame: Baseline (week 1), Post (week 8) and Follow-up (week 16) ]We will examine whether students improve on mindfulness variables (observing, acting with awareness, and being nonjudgmental) after using the program as a secondary process measure.
- Acceptance and Action Questionnaire for University Students [ Time Frame: baseline (week 1), post (week 8), follow-up (week 16) ]We will examine whether students improve on a measure of psychological flexibility tailored specifically to challenges college students experience as a secondary process measure
- Satisfaction with Social Roles and Activities - Short Form Questionnaire [ Time Frame: Baseline (week 1), Post (week 8) and Follow-up (week 16) ]PROMIS measure relating to satisfaction with participating in social roles and activities
- Counseling Questions [ Time Frame: Post (Week 8), and Follow-up (week 16) ](Student Data) We will examine aspects of how the program was used in conjunction with counseling
- Student Implementation and Satisfaction Questions [ Time Frame: post (week 8) and follow-up (week 16) ](Student Data) Assesses the user's satisfaction with and use of the program in the student counseling center context
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761681
|United States, Nevada|
|Contextual Change, LLC|
|Reno, Nevada, United States, 89519|
|Principal Investigator:||Jacqueline Pistorello||Contextual Change LLC|
|Principal Investigator:||Michael Levin||Contextual Change LLC|
|Principal Investigator:||Crissa Levin||Contextual Change LLC|