Clinical trial NCT01808404: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help
Official title: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: College Student Mental Health
Keywords: Acceptance and Commitment Therapy
Mindfulness
Guided Self-Help
College
Lead sponsor: Contextual Change LLC
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for Counselors:

* 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

Exclusion Criteria for Counselors:

* Prior participation in this study

Inclusion Criteria for Student Clients:

* 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 for Student Clients:

* 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.

Primary outcomes:
measure: System Usability Scale
timeFrame: Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)
measure: Program Knowledge Questionnaire
timeFrame: Baseline to Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale
timeFrame: Baseline to Post (Student clients 4 weeks after baseline)
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline to Post (Student clients 4 weeks after baseline)
measure: Personal Values Questionnaire
timeFrame: Baseline to Post (Student clients 4 weeks after baseline)
measure: Acceptance and Action Questionnaire - II
timeFrame: Baseline to Post (Student clients 4 weeks after baseline)
measure: Satisfaction With Life Scale
timeFrame: Baseline to Post (Student clients 4 weeks after baseline)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Worcester Polytechnic Institute Student Development and Counseling Center
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University Counseling Center
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina Counseling and Psychological Services
state: North Carolina
city: Providence
country: United States
facility: Rhode Island School of DesignOffice of Student Development and Counseling Services
state: Rhode Island
Study officials:
affiliation: Contextual Change LLC
name: Michael E. Levin, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Contextual Change LLC
name: Jacqueline Pistorello, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: