Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase II)
NCT ID: NCT02761681
Last Updated: 2019-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
221 participants
INTERVENTIONAL
2015-04-30
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help
NCT01808404
Self-help Books for Student Mental Health
NCT03779412
Comparison of Mindfulness Meditation Tools For College Students
NCT03402009
Implementing Learning 2 BREATHE in Campus Connections
NCT04927286
Self-help Books for Social Anxiety
NCT03297619
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
ACT-CL Web-based guided self-help
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.
Control Web-based guided self-help
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACT-CL Web-based guided self-help
Control Web-based guided self-help
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (Stage 1a: Counselor Focused Interviews): Willing to spend approximately 9 hours across 5-7 phone or web conferences discussing elements and content of the web-based program as modules are developed
* (Stage 1a: Counselor Focused Interviews): Participation will comply with targeted enrollment plans
* (Stage 1b: Student Focused Interviews): Currently being treated at a local CCC, and seen by a counselor for a minimum of 4 sessions.
* (Stage 1b: Student Focused Interviews): Between the ages of 18-25
* (Stage 1b: Student Focused Interviews): Willing to spend approximately 10 hours across 8-12 phone or web conference sessions discussing elements of content of the web-based, guided self-help program as modules are developed.
* (Stage 1b: Student Focused Interviews): Student is currently not suicidal or homicidal, and does not have a history of psychosis
* (Stage 1b: Student Focused Interviews): Participation will comply with targeted enrollment plans, which also include adequate representation of participants across various clinical presentations
* (Stage 1c: Director Focused Interviews): Currently working at a CCC as a director, or previously worked at a CCC as a director for more than 1 year
* (Stage 1b: Student Focused Interviews): Willing to spend approximately 9 hours across 5-7 phone or web conference sessions discussing elements and content of the web-based, guided self help program as modules are developed.
* (Stage 1b: Student Focused Interviews): Participation will comply with targeted enrollment plans.
* (Stage 2a: Counselor RCT): Currently working at a CCC that received internal/local IRB approval for this study
* (Stage 2a: Counselor RCT): Willingness to be randomized to either ACT+TAU or a Psychoeducation+TAU condition
* (Stage 2a: Counselor RCT): If randomized to ACT+TAU, willingness to take the ACT guided self-help training during the 4 weeks prior to the start of the Fall 2016 semester, until reaching a passing criterion of 80% (which will take approximately 9 hours)
* (Stage 2a: Counselor RCT): Willingness to attempt to recruit 10 student clients to participate either in the ACT self-help modules (if counselor is in ACT+TAU condition) or in the psychoeducation website (if counselor is in Psychoeducation+TAU)
* (Stage 2a: Counselor RCT): Willingness to monitor all student participants they recruit as long as students remain active participants (with the potential to de-activate students whose continued participation in the study may be contraindicated).
* (Stage 2a: Counselor RCT): Participation will comply with targeted enrollment plans
* (Stage 2b: Student Program Evaluation): Currently being treated at a CCC
* (Stage 2b: Student Program Evaluation): Students receiving counseling from ACT+TAU counselors: As covered on the consent form, willingness to participate in eight 30-minute modules as part of a web-based guided self-help program and complete pre- and post-assessments across a period of 10 weeks, OR Students receiving counseling from Psychoeducation+TAU counselors: As covered on the consent form, willingness to access psychoeducational website and complete three sets of questionnaires: one at the start of the study, another set 10 weeks later, and a follow-up set to 2 months after the post.
* (Stage 2b: Student Program Evaluation): Referred to study by counselor; cannot self-refer
* (Stage 2b: Student Program Evaluation): Student is clinically stable as per counselor judgment (e.g., not suicidal, psychotic, disruptive)
* (Stage 2b: Student Program Evaluation): Participation will comply with the targeted enrollment plans
Exclusion Criteria
* (Stage 1b: Student Focused Interviews): Under 18 years old
* (Stage 1b: Student Focused Interviews): Lack of fluency in English at the 7th grade level
* (Stage 1c: Director Focused Interviews): Very uncomfortable with technology (Scoring 0-1 on a 0-5 Likert-like scale on comfort with web-based presentations)
* (Stage 2a: Counselor RCT): None
* (Stage 2b: Student Program Evaluation): Under 18 years old
* (Stage 2b: Student Program Evaluation): Lack of fluency in English at the 7th grade level.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Contextual Change LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacqueline Pistorello
Role: PRINCIPAL_INVESTIGATOR
Contextual Change LLC
Michael Levin
Role: PRINCIPAL_INVESTIGATOR
Contextual Change LLC
Crissa Levin
Role: PRINCIPAL_INVESTIGATOR
Contextual Change LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Contextual Change, LLC
Reno, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.