<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779412</url>
  </required_header>
  <id_info>
    <org_study_id>9792</org_study_id>
    <nct_id>NCT03779412</nct_id>
  </id_info>
  <brief_title>Self-help Books for Student Mental Health</brief_title>
  <official_title>A Randomized Controlled Trial (RCT) Comparing Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Stress Reduction (MBSR) Self-help Books for College Student Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Utah State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Utah State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to compare the efficacy and mechanisms of change of two self-help&#xD;
      books for college student mental health in a randomized controlled trial. One book is based&#xD;
      on mindfulness-based stress reduction (MBSR), and one is based on acceptance and commitment&#xD;
      therapy (ACT).&#xD;
&#xD;
      This study will test the following hypotheses:&#xD;
&#xD;
        1. The ACT and MBSR books will both be feasible and acceptable with college students as&#xD;
           evidenced by equivalently high satisfaction and engagement rates.&#xD;
&#xD;
        2. The ACT and MBSR books will be equally effective in improving mental health and&#xD;
           well-being among college students.&#xD;
&#xD;
        3. The ACT book will produce larger improvements in valued action, and the MBSR book will&#xD;
           produce larger improvements in mindfulness.&#xD;
&#xD;
        4. Valued action will be a stronger predictor of improvements in mental health in the ACT&#xD;
           condition and mindfulness will be a stronger predictor of improvements in the&#xD;
           mindfulness condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to recruit 150 college students for this RCT (75 per treatment&#xD;
      condition). This will provide adequate power (0.80) to detect differences between groups of&#xD;
      medium effect size (d=0.50). Note that detailed eligibility criteria are listed in the&#xD;
      &quot;Eligibility&quot; section. Participants will be recruited via SONA (a participant recruitment&#xD;
      system), flyers, online postings, classroom announcements, and through a general online&#xD;
      screener for various Utah State University (USU) Contextual Behavioral Science (CBS) Lab&#xD;
      studies.&#xD;
&#xD;
      Total study participation will occur over approximately 8 weeks. all study procedures will be&#xD;
      completed online, on a computer/mobile phone. After completing informed consent, participants&#xD;
      will complete a baseline survey.&#xD;
&#xD;
      At the end of the baseline survey, participants will be randomly assigned to use a book based&#xD;
      on ACT (The Happiness Trap) or MBSR (A Mindfulness-Based Stress Reduction Workbook).&#xD;
      Participants will be asked not to access other self-help books during the study duration.&#xD;
      Participants will be provided with an 8-week reading schedule and a link to the assigned&#xD;
      book. Participants will be asked to complete a mid-treatment survey 4 weeks after the&#xD;
      beginning of treatment. The mid-treatment survey will include questions about adherence.&#xD;
      Participants will be asked to complete a post-treatment survey 8 weeks after the beginning of&#xD;
      treatment. This survey will also ask about adherence (reading, use of strategies taught in&#xD;
      the book). Researcher contact will involve reminders to complete assessments, basic email&#xD;
      assistance in identifying and responding to any barriers to using the self-help book, and&#xD;
      twice-weekly reminders of the suggested reading schedule.&#xD;
&#xD;
      After completing the initial assessment participants will be sent a link to The Happiness&#xD;
      Trap if they are assigned to the ACT condition, or a link to the Mindfulness-Based Stress&#xD;
      Reduction Workbook if they are in the MBSR condition. They will be able to access the book&#xD;
      online at any time. Participants will be asked to read assigned chapters on an 8-week&#xD;
      schedule.&#xD;
&#xD;
      The Happiness Trap is based on Acceptance and Commitment Therapy, a modern cognitive&#xD;
      behavioral therapy that combines acceptance and mindfulness methods with values and behavior&#xD;
      change methods. The primary treatment components in The Happiness Trap are psychoeducation of&#xD;
      ACT, defusion, acceptance, mindfulness, self-as-context, value, behavioral commitment.&#xD;
&#xD;
      A Mindfulness-Based Stress Reduction Workbook is based on Mindfulness-Based Stress Reduction,&#xD;
      a standardized approach to teaching mindfulness, primarily through meditation practices. The&#xD;
      primary treatment components in A Mindfulness-Based Stress Reduction Workbook are&#xD;
      psychoeducation about mindfulness and mindfulness meditation and various types of mindfulness&#xD;
      meditation practice, such as mind-body connection, loving-kindness meditation, interpersonal&#xD;
      mindfulness, and the healthy path of mindful eating, exercise, rest, and connection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Depression, Anxiety and Stress</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>Depression, Anxiety and Stress Scale (DASS) : a self-report measure of depression, anxiety, and stress symptoms. Higher scores indicate higher negative emotional states of depression, anxiety, and stress. This measure assesses each of these symptoms as a distinct subscale. Items are rated on a 4-point scale ranging from 0 &quot;did not apply to me at all&quot; to 3 &quot;applied to me very much, or most of the time.&quot; Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Valuing Questionnaire (VQ) at 4 weeks and 8 weeks</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>A self-report measure of valued action. This is a 10-item measure, and each item is rated on a 7-point scale ranging from 0 &quot;not at all true&quot; to 6 &quot;completely true.&quot; The VQ is a new measure, but initial validation results indicate adequate reliability and validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) at 4 weeks and 8 weeks.</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>A self-report measure of five facets of mindfulness: observing, describing, acting with awareness, being nonjudgmental, and nonreactivity. The FFMQ is a 39-item questionnaire, and each FFMQ item is rated on a 5-point scale ranging from 1 (&quot;never or very rarely true&quot;) to 5 (&quot;very often or always true&quot;). The FFMQ has been found to be a reliable and valid measure of mindfulness in past research.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental Health Continuum - Short Form (MHC-SF)</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>A self-report measure of positive mental health, composed of three subscales assessing emotional, psychological and social well-being. Items assess theoretically meaningful dimensions of wellbeing including positive affect, satisfaction with life, social integration, social contribution, autonomy, personal growth, purpose in life, and self-acceptance. Items are rated on a 6-point scale ranging from &quot;never&quot; to &quot;every day.&quot; The MHC-SF has been found to have adequate reliability and validity in past research.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Counseling Center Assessment of Psychological Symptoms (CCAPS)-Academic Distress Subscale (CCMH, 2012).</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>The 5-item CCAPS academic distress subscale from the CCAPS-62 will be used to assess academic functioning. Items are rated on a 5-point scale ranging from 0 &quot;not at all like me&quot; to 4 &quot;Extremely like me.&quot; The CCAPS has been found to have adequate reliability and validity in past studies with college students.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and Action Questionnaire-University Students (AAQ-US).</measure>
    <time_frame>Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>A self-report measure of psychological inflexibility designed specifically for university students. Items are rated on a 7-point scale ranging from 1 &quot;never true&quot; to 7 &quot;always true.&quot; Although this is a new scale, preliminary research supports its reliability and validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Fusion Questionnaire (CFQ).</measure>
    <time_frame>Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>A self-report measure of cognitive fusion, an important process related to mindfulness and ACT. Items are rated on a 7-point scale ranging from 1 &quot;never true&quot; to 7 &quot;always true.&quot; Initial validation study found adequate reliability and validity with populations including college students.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adherence</measure>
    <time_frame>Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)</time_frame>
    <description>Participants will also be asked to rate their adherence to the exercises in the book on a 7-point scale from &quot;Did all recommended assignments&quot; to &quot;Did no recommended assignments.&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with the self-help book</measure>
    <time_frame>Posttreatment (8 weeks after baseline)</time_frame>
    <description>Participants will be asked to rate 7 items evaluating their satisfaction with the self-help book on a 6-point scale from &quot;Strongly disagree&quot; to &quot;Strongly agree.&quot;</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Mental Health</condition>
  <arm_group>
    <arm_group_label>ACT self-help book condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will be assigned to read The Happiness Trap by Harris (2008), a self-help book based on acceptance and commitment therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBSR self-help book condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this condition will be assigned to read A Mindfulness-Based Stress Reduction Workbook by Stahl and Goldstein (2010), a self-help book based on Mindfulness-Based Stress Reduction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Happiness Trap</intervention_name>
    <description>Participants assigned to this condition will be asked to read this self-help book over an 8-week period.</description>
    <arm_group_label>ACT self-help book condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A Mindfulness-Based Stress Reduction Workbook</intervention_name>
    <description>Participants assigned to this condition will be asked to read this self-help book over an 8-week period.</description>
    <arm_group_label>MBSR self-help book condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Enrolled at Utah State University&#xD;
&#xD;
          -  Have not participated in other self-help studies run by the USU CBS Lab&#xD;
&#xD;
          -  Interested in using self-help book for improving mental health and well-being&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below the age of 18&#xD;
&#xD;
          -  Not a student at Utah State University&#xD;
&#xD;
          -  Have participated in previous self-help studies run by the CBS Lab&#xD;
&#xD;
          -  Not interested in using a self-help book for improving mental health and well-being&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Levin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Utah State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Utah State University</name>
      <address>
        <city>Logan</city>
        <state>Utah</state>
        <zip>84322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.</citation>
    <PMID>18514614</PMID>
  </reference>
  <reference>
    <citation>Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.</citation>
    <PMID>16443717</PMID>
  </reference>
  <reference>
    <citation>Blanco C, Okuda M, Wright C, Hasin DS, Grant BF, Liu SM, Olfson M. Mental health of college students and their non-college-attending peers: results from the National Epidemiologic Study on Alcohol and Related Conditions. Arch Gen Psychiatry. 2008 Dec;65(12):1429-37. doi: 10.1001/archpsyc.65.12.1429.</citation>
    <PMID>19047530</PMID>
  </reference>
  <reference>
    <citation>Center for Collegiate Mental Health (2012). CCAPS 2012 Technical Manual. University Park, PA</citation>
  </reference>
  <reference>
    <citation>Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.</citation>
    <PMID>24411117</PMID>
  </reference>
  <reference>
    <citation>Harris, R. (2007). The happiness trap: How to stop struggling and start living. Penguin Random House.</citation>
  </reference>
  <reference>
    <citation>Hayes, S. C., Strosahl, K. D., &amp; Wilson, K. G. (2011). Acceptance and Commitment Therapy: The process and practice of mindful change. New York: The Guilford Press.</citation>
  </reference>
  <reference>
    <citation>Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141-68. doi: 10.1146/annurev-clinpsy-032210-104449.</citation>
    <PMID>21219193</PMID>
  </reference>
  <reference>
    <citation>Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.</citation>
    <PMID>20123251</PMID>
  </reference>
  <reference>
    <citation>Kabat-Zinn J. (1990). Full Catastrophe Living. New York: Delacorte.</citation>
  </reference>
  <reference>
    <citation>Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.</citation>
    <PMID>15982151</PMID>
  </reference>
  <reference>
    <citation>Levin ME, Krafft J, Levin C. Does self-help increase rates of help seeking for student mental health problems by minimizing stigma as a barrier? J Am Coll Health. 2018 May-Jun;66(4):302-309. doi: 10.1080/07448481.2018.1440580. Epub 2018 Apr 19.</citation>
    <PMID>29447600</PMID>
  </reference>
  <reference>
    <citation>Levin, M.E., Krafft, J., Pistorello, J. &amp; Seeley, J.R. (In Press). Assessing psychological inflexibility in university students: Development and validation of the acceptance and action questionnaire for university students (AAQ-US). Journal of Contextual Behavioral Science.</citation>
  </reference>
  <reference>
    <citation>Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.</citation>
    <PMID>24313693</PMID>
  </reference>
  <reference>
    <citation>Levin, M.E., Stocke, K., Pierce, B. &amp; Levin, C. (2018). Do college students use online self-help? A survey of intentions and use of mental health resources. Journal of College Student Psychotherapy, 32, 181-198.</citation>
  </reference>
  <reference>
    <citation>Lovibond, S. H. &amp; Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney, AU: Psychology Foundation of Australia.</citation>
  </reference>
  <reference>
    <citation>McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.</citation>
    <PMID>25181605</PMID>
  </reference>
  <reference>
    <citation>Rosen, G.M., &amp; Lilienfeld, S.O. (2016). On the failure of psychology to advance self-help: Acceptance and Commitment Therapy (ACT) as a case example. Journal of Contemporary Psychotherapy, 46, 71-77.</citation>
  </reference>
  <reference>
    <citation>Sevilla-Llewellyn-Jones J, Santesteban-Echarri O, Pryor I, McGorry P, Alvarez-Jimenez M. Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. JMIR Ment Health. 2018 Sep 25;5(3):e10278. doi: 10.2196/10278.</citation>
    <PMID>30274963</PMID>
  </reference>
  <reference>
    <citation>Smout, M.F., Davies, M., Burns, N., &amp; Christie, A. (2014). Evaluating acceptance and commitment therapy: Development of the valuing questionnaire. Journal of Contextual Behavioral Science, 3, 164-172.</citation>
  </reference>
  <reference>
    <citation>Stahl, B. &amp; Goldstein, E. (2010). A Mindfulness-Based Stress Reduction Workbook. New Harbinger Publications</citation>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Utah State University</investigator_affiliation>
    <investigator_full_name>Michael Levin</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779412
org study id: 9792
nct id: NCT03779412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to compare the efficacy and mechanisms of change of two self-help
      books for college student mental health in a randomized controlled trial. One book is based
      on mindfulness-based stress reduction (MBSR), and one is based on acceptance and commitment
      therapy (ACT).

      This study will test the following hypotheses:

        1. The ACT and MBSR books will both be feasible and acceptable with college students as
           evidenced by equivalently high satisfaction and engagement rates.

        2. The ACT and MBSR books will be equally effective in improving mental health and
           well-being among college students.

        3. The ACT book will produce larger improvements in valued action, and the MBSR book will
           produce larger improvements in mindfulness.

        4. Valued action will be a stronger predictor of improvements in mental health in the ACT
           condition and mindfulness will be a stronger predictor of improvements in the
           mindfulness condition.
The investigators aim to recruit 150 college students for this RCT (75 per treatment
      condition). This will provide adequate power (0.80) to detect differences between groups of
      medium effect size (d=0.50). Note that detailed eligibility criteria are listed in the
      "Eligibility" section. Participants will be recruited via SONA (a participant recruitment
      system), flyers, online postings, classroom announcements, and through a general online
      screener for various Utah State University (USU) Contextual Behavioral Science (CBS) Lab
      studies.

      Total study participation will occur over approximately 8 weeks. all study procedures will be
      completed online, on a computer/mobile phone. After completing informed consent, participants
      will complete a baseline survey.

      At the end of the baseline survey, participants will be randomly assigned to use a book based
      on ACT (The Happiness Trap) or MBSR (A Mindfulness-Based Stress Reduction Workbook).
      Participants will be asked not to access other self-help books during the study duration.
      Participants will be provided with an 8-week reading schedule and a link to the assigned
      book. Participants will be asked to complete a mid-treatment survey 4 weeks after the
      beginning of treatment. The mid-treatment survey will include questions about adherence.
      Participants will be asked to complete a post-treatment survey 8 weeks after the beginning of
      treatment. This survey will also ask about adherence (reading, use of strategies taught in
      the book). Researcher contact will involve reminders to complete assessments, basic email
      assistance in identifying and responding to any barriers to using the self-help book, and
      twice-weekly reminders of the suggested reading schedule.

      After completing the initial assessment participants will be sent a link to The Happiness
      Trap if they are assigned to the ACT condition, or a link to the Mindfulness-Based Stress
      Reduction Workbook if they are in the MBSR condition. They will be able to access the book
      online at any time. Participants will be asked to read assigned chapters on an 8-week
      schedule.

      The Happiness Trap is based on Acceptance and Commitment Therapy, a modern cognitive
      behavioral therapy that combines acceptance and mindfulness methods with values and behavior
      change methods. The primary treatment components in The Happiness Trap are psychoeducation of
      ACT, defusion, acceptance, mindfulness, self-as-context, value, behavioral commitment.

      A Mindfulness-Based Stress Reduction Workbook is based on Mindfulness-Based Stress Reduction,
      a standardized approach to teaching mindfulness, primarily through meditation practices. The
      primary treatment components in A Mindfulness-Based Stress Reduction Workbook are
      psychoeducation about mindfulness and mindfulness meditation and various types of mindfulness
      meditation practice, such as mind-body connection, loving-kindness meditation, interpersonal
      mindfulness, and the healthy path of mindful eating, exercise, rest, and connection.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Depression, Anxiety and Stress
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: Depression, Anxiety and Stress Scale (DASS) : a self-report measure of depression, anxiety, and stress symptoms. Higher scores indicate higher negative emotional states of depression, anxiety, and stress. This measure assesses each of these symptoms as a distinct subscale. Items are rated on a 4-point scale ranging from 0 "did not apply to me at all" to 3 "applied to me very much, or most of the time." Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively.
measure: Change from Baseline Valuing Questionnaire (VQ) at 4 weeks and 8 weeks
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: A self-report measure of valued action. This is a 10-item measure, and each item is rated on a 7-point scale ranging from 0 "not at all true" to 6 "completely true." The VQ is a new measure, but initial validation results indicate adequate reliability and validity.
measure: Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) at 4 weeks and 8 weeks.
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: A self-report measure of five facets of mindfulness: observing, describing, acting with awareness, being nonjudgmental, and nonreactivity. The FFMQ is a 39-item questionnaire, and each FFMQ item is rated on a 5-point scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). The FFMQ has been found to be a reliable and valid measure of mindfulness in past research.
measure: Mental Health Continuum - Short Form (MHC-SF)
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: A self-report measure of positive mental health, composed of three subscales assessing emotional, psychological and social well-being. Items assess theoretically meaningful dimensions of wellbeing including positive affect, satisfaction with life, social integration, social contribution, autonomy, personal growth, purpose in life, and self-acceptance. Items are rated on a 6-point scale ranging from "never" to "every day." The MHC-SF has been found to have adequate reliability and validity in past research.
measure: Counseling Center Assessment of Psychological Symptoms (CCAPS)-Academic Distress Subscale (CCMH, 2012).
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: The 5-item CCAPS academic distress subscale from the CCAPS-62 will be used to assess academic functioning. Items are rated on a 5-point scale ranging from 0 "not at all like me" to 4 "Extremely like me." The CCAPS has been found to have adequate reliability and validity in past studies with college students.
measure: Acceptance and Action Questionnaire-University Students (AAQ-US).
time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: A self-report measure of psychological inflexibility designed specifically for university students. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." Although this is a new scale, preliminary research supports its reliability and validity.
measure: Cognitive Fusion Questionnaire (CFQ).
time frame: Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: A self-report measure of cognitive fusion, an important process related to mindfulness and ACT. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." Initial validation study found adequate reliability and validity with populations including college students.
measure: Adherence
time frame: Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
description: Participants will also be asked to rate their adherence to the exercises in the book on a 7-point scale from "Did all recommended assignments" to "Did no recommended assignments."
measure: Satisfaction with the self-help book
time frame: Posttreatment (8 weeks after baseline)
description: Participants will be asked to rate 7 items evaluating their satisfaction with the self-help book on a 6-point scale from "Strongly disagree" to "Strongly agree."
arm group label: ACT self-help book condition
arm group type: Experimental
description: Participants in this condition will be assigned to read The Happiness Trap by Harris (2008), a self-help book based on acceptance and commitment therapy.
arm group label: MBSR self-help book condition
arm group type: Active Comparator
description: Participants in this condition will be assigned to read A Mindfulness-Based Stress Reduction Workbook by Stahl and Goldstein (2010), a self-help book based on Mindfulness-Based Stress Reduction.
intervention type: Behavioral
intervention name: The Happiness Trap
description: Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
arm group label: ACT self-help book condition
intervention type: Behavioral
intervention name: A Mindfulness-Based Stress Reduction Workbook
description: Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
arm group label: MBSR self-help book condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Levin, PhD
role: Principal Investigator
affiliation: Utah State University
facility: 
country: United States
citation: Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.
PMID: 18514614
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PMID: 16443717
citation: Blanco C, Okuda M, Wright C, Hasin DS, Grant BF, Liu SM, Olfson M. Mental health of college students and their non-college-attending peers: results from the National Epidemiologic Study on Alcohol and Related Conditions. Arch Gen Psychiatry. 2008 Dec;65(12):1429-37. doi: 10.1001/archpsyc.65.12.1429.
PMID: 19047530
citation: Center for Collegiate Mental Health (2012). CCAPS 2012 Technical Manual. University Park, PA
citation: Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
PMID: 24411117
citation: Harris, R. (2007). The happiness trap: How to stop struggling and start living. Penguin Random House.
citation: Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and Commitment Therapy: The process and practice of mindful change. New York: The Guilford Press.
citation: Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141-68. doi: 10.1146/annurev-clinpsy-032210-104449.
PMID: 21219193
citation: Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.
PMID: 20123251
citation: Kabat-Zinn J. (1990). Full Catastrophe Living. New York: Delacorte.
citation: Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
PMID: 15982151
citation: Levin ME, Krafft J, Levin C. Does self-help increase rates of help seeking for student mental health problems by minimizing stigma as a barrier? J Am Coll Health. 2018 May-Jun;66(4):302-309. doi: 10.1080/07448481.2018.1440580. Epub 2018 Apr 19.
PMID: 29447600
citation: Levin, M.E., Krafft, J., Pistorello, J. & Seeley, J.R. (In Press). Assessing psychological inflexibility in university students: Development and validation of the acceptance and action questionnaire for university students (AAQ-US). Journal of Contextual Behavioral Science.
citation: Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.
PMID: 24313693
citation: Levin, M.E., Stocke, K., Pierce, B. & Levin, C. (2018). Do college students use online self-help? A survey of intentions and use of mental health resources. Journal of College Student Psychotherapy, 32, 181-198.
citation: Lovibond, S. H. & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney, AU: Psychology Foundation of Australia.
citation: McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.
PMID: 25181605
citation: Rosen, G.M., & Lilienfeld, S.O. (2016). On the failure of psychology to advance self-help: Acceptance and Commitment Therapy (ACT) as a case example. Journal of Contemporary Psychotherapy, 46, 71-77.
citation: Sevilla-Llewellyn-Jones J, Santesteban-Echarri O, Pryor I, McGorry P, Alvarez-Jimenez M. Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. JMIR Ment Health. 2018 Sep 25;5(3):e10278. doi: 10.2196/10278.
PMID: 30274963
citation: Smout, M.F., Davies, M., Burns, N., & Christie, A. (2014). Evaluating acceptance and commitment therapy: Development of the valuing questionnaire. Journal of Contextual Behavioral Science, 3, 164-172.
citation: Stahl, B. & Goldstein, E. (2010). A Mindfulness-Based Stress Reduction Workbook. New Harbinger Publications
responsible party type: Principal Investigator
investigator affiliation: Utah State University
investigator full name: Michael Levin
investigator title: Associate Professor
sharing ipd: Undecided