Mental HealthNCT02761681
Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help (Phase II)
A study testing ACT-CL Web-based guided self-help in people with Mental Health, run by Contextual Change LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- ACT-CL 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
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2019
- Phase
- Interventional
- 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
- (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.
Show all 22Show fewer
- (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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness and Acceptance Applied in Colleges Through Web-Based Guided Self-Help
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.
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 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.
- Conditions
- Mental Health
- Being tested
- ACT-CL Web-based guided self-help, Control Web-based guided self-help
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Guided self-help, College students, Focused Interviews, RCT Control Condition, RCT ACT-CL Condition
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-CL Web-based guided self-helpBehavioural
Control Web-based guided self-helpBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ACT-CL Web-based guided self-help | Experimental | Behavioral: Experimental Web-based guided self-help Program This intervention will involve counselor training and student use of the developed program. Counselors will complete training and invite students to participate, and will monitor and guide students in completing the series of 8 web-based sessions based on Acceptance and Commitment Therapy. Receives: Behavioral: ACT-CL Web-based guided self-help |
| Control Web-based guided self-help | Active comparator | Behavioral: Control Web-based guided self-help program This intervention will be created for the current study. It will involve psycho-education on how students might get the most out of counseling. Counselors will go through the psycho-education session before inviting students to participate. Receives: Behavioral: Control Web-based guided self-help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62
(Student Data) We will assess the change in various diagnoses and presentations common in college students (such as depression, anxiety, eating disorders, substance abuse, etc). This will be our primary outcome measure for students.
Measured: Baseline (week 1), Post (week 8), Follow-up (week 16)
Secondary outcomes (11)
System Usability Scale
(Counselor and Student Data) Program usability/acceptability will be a primary outcome
Measured: Post (week 8 or week 20)
ACT Knowledge Questionnaire
(Counselor Data) We will examine whether counselors improve in their knowledge of ACT concepts after going through the program to assess initial feasibility of the prototype program.
Measured: Baseline (week 1) and post (week 20)
Counselor Implementation Questions
(Counselor Data) We will examine whether counselors were satisfied with the program utility, efficiency, and content and will explore the potential for subsequent dissemination of the website.
Measured: Post (week 20)
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 (week 1), Post (week 8) and Follow-up (week 16)
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 (week 1), Post (week 8) and Follow-up (week 16)
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 (week 1), Post (week 8) and Follow-up (week 16)
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 (week 1), Post (week 8) and Follow-up (week 16)
Acceptance and Action Questionnaire for University Students
We will examine whether students improve on a measure of psychological flexibility tailored specifically to challenges college students experience as a secondary process measure
Measured: baseline (week 1), post (week 8), follow-up (week 16)
Satisfaction with Social Roles and Activities - Short Form Questionnaire
PROMIS measure relating to satisfaction with participating in social roles and activities
Measured: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Counseling Questions
(Student Data) We will examine aspects of how the program was used in conjunction with counseling
Measured: Post (Week 8), and Follow-up (week 16)
Student Implementation and Satisfaction Questions
(Student Data) Assesses the user's satisfaction with and use of the program in the student counseling center context
Measured: post (week 8) and follow-up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contextual Change LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Pistorello, Principal investigator, Contextual Change LLCMichael Levin, Principal investigator, Contextual Change LLCCrissa Levin, Principal investigator, Contextual Change LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761681
- Sponsor's protocol ID
- R44AT006952
- Status last verified
- Jul 2019
- First submitted
- 30 Apr 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. 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
- ClinicalTrials.gov ID
- NCT02761681
- Acronym / sponsor ID
- R44AT006952
- Conditions
- Mental Health
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Guided self-help, College students, Focused Interviews, RCT Control Condition, RCT ACT-CL Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Contextual Change LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 4 May 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-CL Web-based guided self-help | Experimental | Behavioral: ACT-CL Web-based guided self-helpBehavioral: Experimental Web-based guided self-help Program This intervention will involve counselor training and student use of the developed program. Counselors will complete training and invite students to participate, and will monitor and guide students in completing the series of 8 web-based sessions based on Acceptance and Commitment Therapy. |
| Control Web-based guided self-help | Active comparator | Behavioral: Control Web-based guided self-helpBehavioral: Control Web-based guided self-help program This intervention will be created for the current study. It will involve psycho-education on how students might get the most out of counseling. Counselors will go through the psycho-education session before inviting students to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- (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
Key exclusion criteria (7 listed)
- (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
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 |
|---|---|---|
| ACT-CL Web-based guided self-help | Behavioural | ACT-CL Web-based guided self-help |
| Control Web-based guided self-help | Behavioural | Control Web-based guided self-help |
Primary outcome
Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62
Time frame: Baseline (week 1), Post (week 8), Follow-up (week 16)
(Student Data) We will assess the change in various diagnoses and presentations common in college students (such as depression, anxiety, eating disorders, substance abuse, etc). This will be our primary outcome measure for students.
11 secondary outcomes
System Usability Scale
Time frame: Post (week 8 or week 20)
ACT Knowledge Questionnaire
Time frame: Baseline (week 1) and post (week 20)
Counselor Implementation Questions
Time frame: Post (week 20)
Personal Values Questionnaire
Time frame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Satisfaction with Life Scale
Time frame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Acceptance and Action Questionnaire - II
Time frame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Five Facet Mindfulness Questionnaire
Time frame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Acceptance and Action Questionnaire for University Students
Time frame: baseline (week 1), post (week 8), follow-up (week 16)
Satisfaction with Social Roles and Activities - Short Form Questionnaire
Time frame: Baseline (week 1), Post (week 8) and Follow-up (week 16)
Counseling Questions
Time frame: Post (Week 8), and Follow-up (week 16)
Student Implementation and Satisfaction Questions
Time frame: post (week 8) and follow-up (week 16)
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 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Jacqueline Pistorello principal investigator
Contextual Change LLC
Michael Levin principal investigator
Contextual Change LLC
Crissa Levin principal investigator
Contextual Change LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-CL Web-based guided self-help in people with Mental Health, run by Contextual Change LLC at 1 site 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 22 inclusion and 7 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62 (time frame: Baseline (week 1), Post (week 8), Follow-up (week 16)). 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 Jul 2019.