Clinical trial NCT02761681: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase II)
Official title: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Acceptance and Commitment Therapy
Mindfulness
Guided self-help
College students
Focused Interviews
RCT Control Condition
RCT ACT-CL Condition
Lead sponsor: Contextual Change LLC
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and then test a web-based guided self-help version of Acceptance and Commitment Therapy (ACT) to be utilized at college counseling centers (CCCs). ACT is 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* (Stage 1a: Counselor Focused Interviews): Currently working at CCC or previously worked at CCC for more than 1 year
* (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 1a: Counselor Focused Interviews): Very uncomfortable with technology (Scoring 0-1 on a 0-5 Likert-like scale on comfort with web-based presentations)
* (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.

Primary outcomes:
measure: Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62
timeFrame: Baseline (week 1), Post (week 8), Follow-up (week 16)
Secondary outcomes:
measure: System Usability Scale
timeFrame: Post (week 8 or week 20)
measure: ACT Knowledge Questionnaire
timeFrame: Baseline (week 1) and post (week 20)
measure: Counselor Implementation Questions
timeFrame: Post (week 20)
measure: Personal Values Questionnaire
timeFrame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
measure: Satisfaction with Life Scale
timeFrame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
measure: Acceptance and Action Questionnaire - II
timeFrame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
measure: Acceptance and Action Questionnaire for University Students
timeFrame: baseline (week 1), post (week 8), follow-up (week 16)
measure: Satisfaction with Social Roles and Activities - Short Form Questionnaire
timeFrame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
measure: Counseling Questions
timeFrame: Post (Week 8), and Follow-up (week 16)
measure: Student Implementation and Satisfaction Questions
timeFrame: post (week 8) and follow-up (week 16)
Other outcomes:
Locations:
city: Reno
country: United States
facility: Contextual Change, LLC
state: Nevada
Study officials:
affiliation: Contextual Change LLC
name: Jacqueline Pistorello
role: PRINCIPAL_INVESTIGATOR
affiliation: Contextual Change LLC
name: Michael Levin
role: PRINCIPAL_INVESTIGATOR
affiliation: Contextual Change LLC
name: Crissa Levin
role: PRINCIPAL_INVESTIGATOR
References: