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

Phase 1

Completed

• Conditions: College Student Mental Health
• Interventions: Behavioral: Web-Based Guided Self-Help

• Registration Number: NCT01808404
• Lead Sponsor: Contextual Change LLC

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Web-Based Guided Self-Help	Web-Based Guided Self-Help	The study is an open trial and all participants will be assigned to the same intervention arm.

Primary Outcome Measures

Name	Time	Method
Program Knowledge Questionnaire	Baseline to Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)	We will examine whether counselors and students improve in their knowledge of ACT concepts after going through the program to assess initial feasibility of the prototype program.
System Usability Scale	Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)	Program usability/acceptability will be a primary outcome measure for this study for both counselors and students using the program.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Life Scale	Baseline to Post (Student clients 4 weeks after baseline)	We will examine whether students improve on a measure of satisfaction with life after completing the program as a secondary outcome measure.
Depression, Anxiety and Stress Scale	Baseline to Post (Student clients 4 weeks after baseline)	The initial efficacy of the prototype intervention will be examined with students by looking at changes from pre to post on depression, anxiety and stress.
Personal Values Questionnaire	Baseline to Post (Student clients 4 weeks after baseline)	We will examine whether students improve in their connection to and engagement in personal values after completing the program as a secondary process measure.
Five Facet Mindfulness Questionnaire	Baseline to Post (Student clients 4 weeks after baseline)	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 - II	Baseline to Post (Student clients 4 weeks after baseline)	We will examine whether students improve on a measure of psychological flexibility after completing the program as a secondary process measure.

Trial Locations

Locations (4)

Worcester Polytechnic Institute Student Development and Counseling Center; 🇺🇸 Worcester, Massachusetts, United States

Rhode Island School of DesignOffice of Student Development and Counseling Services; 🇺🇸 Providence, Rhode Island, United States

University of North Carolina Counseling and Psychological Services; 🇺🇸 Chapel Hill, North Carolina, United States

Michigan State University Counseling Center; 🇺🇸 East Lansing, Michigan, United States