Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help

NCT ID: NCT01808404

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-09-30

Brief Summary

College counseling centers (CCCs) are being faced with increasing demands for services to meet the treatment needs of their students, in the context of increasingly severe cases and declining resources. Innovative, cost effective solutions are needed.

The proposed project seeks to meet these needs by testing a web-based guided self-help version of Acceptance and Commitment Therapy (ACT), an evidence-based transdiagnostic therapy found to effectively treat a range of psychological problems. An ACT program would provide a means of implementing effective treatment for the range of problems in the CCC setting, while the guided self-help format would reduce counselors' workload, improving cost-effectiveness and reducing waiting lists. This would both treat students and train counselors in how to implement the ACT intervention. Three self-help lessons have been developed, as well as a counselor portal to review students' use of the program and to receive training on implementing ACT guided self-help.

The study is a pre-post, open(i.e., non-randomized) feasibility trial with 20 counselors and 60 clients from multiple CCCs throughout the country.

Detailed Description

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 recruiting participants at several CCCs throughout the country to test a web-based guided self-help version of Acceptance and Commitment Therapy, 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. 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 I) of this Small Business Innovation Research (SBIR) grant, three self-help modules (mindfulness, acceptance of difficult thoughts and feelings, and values exploration) have been developed, as well as a counselor portal to review students' use of the program and to receive training on implementing ACT guided self-help. The current study is a pre-post feasibility trial with at least 20 counselors and 60 clients (3 student clients per CCC counselor) from different CCCs throughout the country. The study is an open trial in which all counselors and clients will use the program and complete assessments and pre and post. The study will examine the initial feasibility, efficacy and acceptability of the program with both students and counselors. These findings will inform the development of a final commercial program to be marketed to CCCs.

Conditions

College Student Mental Health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Web-Based Guided Self-Help

The study is an open trial and all participants will be assigned to the same intervention arm.

Group Type: EXPERIMENTAL

Web-Based Guided Self-Help

Intervention Type: BEHAVIORAL

The intervention will involve counselors using the web-based guided self-help program with their student clients. Counselors will complete a web-based training followed by a period of time in which they will monitor and guide students in completing the program. Students will access a series of three web-based "lessons" in which they will receive an intervention based on Acceptance and Commitment Therapy (ACT) focused on personal values, acceptance of difficult emotions, and mindfulness.

Interventions

Web-Based Guided Self-Help

The intervention will involve counselors using the web-based guided self-help program with their student clients. Counselors will complete a web-based training followed by a period of time in which they will monitor and guide students in completing the program. Students will access a series of three web-based "lessons" in which they will receive an intervention based on Acceptance and Commitment Therapy (ACT) focused on personal values, acceptance of difficult emotions, and mindfulness.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Currently working at a College Counseling Center
• Willingness to take the ACT guided self-help training through the counselor portal until reaching a passing criterion of 80%
• Willingness to distribute flyers about the study to five students, in an attempt to recruit 3 clients to participate in the self-help modules

• Currently being treated at a College Counseling Center
• Willingness to participate in three half-hour modules as part of a web-based guided self-help program and complete pre and post assessments across a period of 4 weeks
• Referred to the study/self-help modules by counselor
• Participation will comply with targeted enrollment plans, and attention will be paid to selecting an ethnically/racially diverse group
• Student is clinically stable as per counselor judgment (e.g., not actively suicidal, psychotic, or disruptive)

Exclusion Criteria

• Prior participation in this study

• Under 18
• Lack of fluency in English 7th grade level
• Prior participation in this study
• Students with current psychotic disorders, risk of harm to self or others, or needing close medical and/or psychiatric oversight will be excluded, based on counselor assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contextual Change LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael E. Levin, M.A.

Role: PRINCIPAL_INVESTIGATOR

Contextual Change LLC

Jacqueline Pistorello, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Contextual Change LLC

Locations

Worcester Polytechnic Institute Student Development and Counseling Center

Worcester, Massachusetts, United States

Michigan State University Counseling Center

East Lansing, Michigan, United States

University of North Carolina Counseling and Psychological Services

Chapel Hill, North Carolina, United States

Rhode Island School of DesignOffice of Student Development and Counseling Services

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R43AT006952

Identifier Type: NIH

Identifier Source: org_study_id

View Link