College Student Mental HealthPhase 1NCT01808404
Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help
A Phase 1 study testing Web-Based Guided Self-Help in people with College Student Mental Health, run by Contextual Change LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- College Student Mental Health
- What is being tested?
- Web-Based Guided Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2013to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina Counseling and Psychological Services
Chapel Hill, North Carolina, 27599
Michigan State University Counseling Center
East Lansing, Michigan, 48824
Rhode Island School of DesignOffice of Student Development and Counseling Services
Providence, Rhode Island, 02906
Worcester Polytechnic Institute Student Development and Counseling Center
Worcester, Massachusetts, 01609
About this study
Official title: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase 1)
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.
Read the 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
- Being tested
- Web-Based Guided Self-Help
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Guided Self-Help, College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Guided Self-HelpBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Guided Self-Help | Experimental | The study is an open trial and all participants will be assigned to the same intervention arm. Receives: Behavioral: Web-Based Guided Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Program usability/acceptability will be a primary outcome measure for this study for both counselors and students using the program.
Measured: Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)
Program Knowledge Questionnaire
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.
Measured: Baseline to Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)
Secondary outcomes (5)
Depression, Anxiety and Stress Scale
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.
Measured: Baseline to Post (Student clients 4 weeks after baseline)
Five Facet Mindfulness Questionnaire
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.
Measured: Baseline to Post (Student clients 4 weeks after baseline)
Personal Values Questionnaire
We will examine whether students improve in their connection to and engagement in personal values after completing the program as a secondary process measure.
Measured: Baseline to Post (Student clients 4 weeks after baseline)
Acceptance and Action Questionnaire - II
We will examine whether students improve on a measure of psychological flexibility after completing the program as a secondary process measure.
Measured: Baseline to Post (Student clients 4 weeks after baseline)
Satisfaction With Life Scale
We will examine whether students improve on a measure of satisfaction with life after completing the program as a secondary outcome measure.
Measured: Baseline to Post (Student clients 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for College Student Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contextual Change LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael E. Levin, M.A., Principal investigator, Contextual Change LLCJacqueline Pistorello, Ph.D., Principal investigator, Contextual Change LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808404
- Sponsor's protocol ID
- R43AT006952
- Status last verified
- Jan 2014
- First submitted
- 6 Mar 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase 1)
- ClinicalTrials.gov ID
- NCT01808404
- Acronym / sponsor ID
- R43AT006952
- Conditions
- College Student Mental Health
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Guided Self-Help, College
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Contextual Change LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-Based Guided Self-Help | Experimental | Behavioral: Web-Based Guided Self-HelpThe study is an open trial and all participants will be assigned to the same intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Guided Self-HelpThe 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. | Behavioural | Web-Based Guided Self-Help |
Primary outcome
System Usability Scale
Time frame: 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.
Program Knowledge Questionnaire
Time frame: 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.
5 secondary outcomes
Depression, Anxiety and Stress Scale
Time frame: Baseline to Post (Student clients 4 weeks after baseline)
Five Facet Mindfulness Questionnaire
Time frame: Baseline to Post (Student clients 4 weeks after baseline)
Personal Values Questionnaire
Time frame: Baseline to Post (Student clients 4 weeks after baseline)
Acceptance and Action Questionnaire - II
Time frame: Baseline to Post (Student clients 4 weeks after baseline)
Satisfaction With Life Scale
Time frame: Baseline to Post (Student clients 4 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E. Levin, M.A. principal investigator
Contextual Change LLC
Jacqueline Pistorello, Ph.D. principal investigator
Contextual Change LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Web-Based Guided Self-Help in people with College Student Mental Health, run by Contextual Change LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Post (Counselors 10 weeks after baseline; Student clients 4 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.