<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/NCT02987582</url>
  </required_header>
  <id_info>
    <org_study_id>EFM 1</org_study_id>
    <nct_id>NCT02987582</nct_id>
  </id_info>
  <brief_title>A Feasibility Study of an Emotion-Focused Mindfulness Group</brief_title>
  <official_title>A Feasibility Study of an Emotion-Focused Mindfulness Group to Enhance Coping and Resilience in Family Medicine Patients Living With Common Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto Practice Based Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto Practice Based Research Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Living with symptoms of mental illness is associated with psychosocial impairment as it can&#xD;
      affect someone's ability to work, their relationships and level of functioning. This also has&#xD;
      high economic costs on a societal level. It has been shown that an increase in&#xD;
      self-compassion may result in a secondary benefit of reducing psychological distress, which&#xD;
      could offer substantial benefits. There is little empirical data on Emotion Focused&#xD;
      Mindfulness (EFM) interventions for the population we are studying. This study aims to&#xD;
      address this gap in the literature and practice, thus advancing the field.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design&#xD;
&#xD;
      The proposed study is a non-controlled, open-label, repeated measures intervention study. It&#xD;
      is a two year feasibility study.&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      Recruitment&#xD;
&#xD;
      Participants will be recruited through the Mount Sinai Academic Family Health Team. Patients&#xD;
      who experience symptoms of depression and/or anxiety, may be referred by any member of the&#xD;
      family health team, self-referrals through the family health team will also be accepted.&#xD;
      Patients will be screened for eligibility for the EFM Group by the group facilitators.&#xD;
      Patients may participate in the EFM group and refuse to participate in the research study.&#xD;
&#xD;
      When patients agree to participate in the group intervention, patients will then be asked&#xD;
      about interest in participating in this research. Group facilitators will provide details&#xD;
      about the study. Interested patients are given the consent form to review. The group&#xD;
      facilitator leaves the room and the research associate will then come into the room to obtain&#xD;
      written consent.&#xD;
&#xD;
      Intervention&#xD;
&#xD;
      The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through&#xD;
      the intervention there will be a 5 hour retreat on the weekend. A typical group format&#xD;
      includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then&#xD;
      group members will have time to report on recollections from meditation and facilitators will&#xD;
      provide feedback. There is a break and the second part of the group focuses on a didactic&#xD;
      teaching topic. Topics change each week. EFM groups will run between September 2016 and June&#xD;
      2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group.</measure>
    <time_frame>Weeks 1, 4, 8 and 2 months post group completion</time_frame>
    <description>26 question self-administered questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Scale (PANAS) to assess change between baseline, midpoint, group completion and 2 months post group.</measure>
    <time_frame>Weeks 1, 4, 8 and 2 months post group completion</time_frame>
    <description>20 item self-report measure of positive and negative affect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire - Somatic Anxiety Depression Scale (PHQ-SADS) to assess change between baseline, midpoint, group completion and 2 months post group.</measure>
    <time_frame>Weeks 1, 4, 8 and 2 months post group completion</time_frame>
    <description>Self-report scales that include the 9 questions for assessing depression; 7 questions for assessing general anxiety; and 15 questions for assessing somatic symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Internalized Shame Scale to assess change between baseline, midpoint, group completion and 2 months post group.</measure>
    <time_frame>Weeks 1, 4, 8 and 2 months post group completion</time_frame>
    <description>30 item self-report scale that measures the phenomenology of the shame experience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Disability Assessment Schedule (WHODAS) to assess change between baseline, midpoint, group completion and 2 months post group.</measure>
    <time_frame>Weeks 1, 4, 8 and 2 months post group completion</time_frame>
    <description>12 item generic assessment instrument for health and disability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Emotion-focused mindfulness group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week mindfulness group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotion-focused mindfulness group</intervention_name>
    <description>Intervention The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week; groups will run between October 2016 and June 2018.</description>
    <arm_group_label>Emotion-focused mindfulness group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Must be patient of Mount Sinai Academic Family Health Team&#xD;
&#xD;
          -  Adults over the age of 18 years&#xD;
&#xD;
          -  Symptoms of depression and anxiety as identified by the patient and/or family&#xD;
             physician&#xD;
&#xD;
          -  Sufficient English language skills to participate in the group (based on assessment of&#xD;
             group facilitators)&#xD;
&#xD;
          -  Committed and willing to engage in the group work, such as listening to others,&#xD;
             speaking in front of others (based on assessment of group facilitators)&#xD;
&#xD;
        Exclusion Criteria: (each based on assessment by group facilitators)&#xD;
&#xD;
          -  Active suicidality&#xD;
&#xD;
          -  Severe depression&#xD;
&#xD;
          -  Possible alcohol abuse&#xD;
&#xD;
          -  High tendency to dissociate&#xD;
&#xD;
          -  Personality style that may disrupt group formation processes, participation in&#xD;
             interpersonal group processes, and/or developing a meditation practice&#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>Rodelyn Wisco, MSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, Sinai Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital, Canada</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.ca/en/hospital/about_camh/newsroom/for_reporters/Pages/addictionmentalhealthstatistics.aspx</url>
    <description>Centre for Addiction and Mental Health. Mental Illness and Addictions: Facts and Statistics</description>
  </link>
  <link>
    <url>http://www.nice.org.uk/guidance/cg90</url>
    <description>National Institute for Health and Care Excellence. Depression in adults: recognition and management.</description>
  </link>
  <link>
    <url>http://www.who.int/classifications/icf/more_whodas/en/</url>
    <description>WHO. WHO Disability Assessment Schedule 2.0</description>
  </link>
  <link>
    <url>https://ww1.cpa-apc.org/Publications/Position_Papers/Shared.asp</url>
    <description>Canadian Psychiatric Association and The College of Family Physicians of Canada</description>
  </link>
  <link>
    <url>https://books.google.ca/books?id=G0ITeV5CJYoC&amp;pg=PA3&amp;lpg=PA3&amp;dq=80%25+primary+care+exclusive+mental+health&amp;source=bl&amp;ots=a1CDlNe1A3&amp;sig=GWf-zOJ9V5fbmpFCpNAUl3qQy94&amp;hl=en&amp;sa=X&amp;ved=0ahUKEwiYya3S-KjQAhVjqFQKHW0-DYgQ6AEILTAC#v=onepage&amp;q=80%25%20primary%20care%20exclusive%20mental%20health&amp;f=false</url>
    <description>Behavioral Medicine: A Primary Care Approach</description>
  </link>
  <reference>
    <citation>Kessler RC, Gruber M, Hettema JM, Hwang I, Sampson N, Yonkers KA. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008 Mar;38(3):365-74. doi: 10.1017/S0033291707002012. Epub 2007 Nov 30.</citation>
    <PMID>18047766</PMID>
  </reference>
  <reference>
    <citation>Patten SB, Gordon-Brown L, Meadows G. Simulation studies of age-specific lifetime major depression prevalence. BMC Psychiatry. 2010 Oct 20;10:85. doi: 10.1186/1471-244X-10-85.</citation>
    <PMID>20961404</PMID>
  </reference>
  <reference>
    <citation>Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.</citation>
    <PMID>25431430</PMID>
  </reference>
  <reference>
    <citation>Canadian Psychiatric Association. Clinical practice guidelines. Management of anxiety disorders. Can J Psychiatry. 2006 Jul;51(8 Suppl 2):9S-91S. No abstract available. Erratum In: Can J Psychiatry. 2006 Sep;51(10):623.</citation>
    <PMID>16933543</PMID>
  </reference>
  <reference>
    <citation>Parikh SV, Segal ZV, Grigoriadis S, Ravindran AV, Kennedy SH, Lam RW, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. II. Psychotherapy alone or in combination with antidepressant medication. J Affect Disord. 2009 Oct;117 Suppl 1:S15-25. doi: 10.1016/j.jad.2009.06.042. Epub 2009 Aug 13.</citation>
    <PMID>19682749</PMID>
  </reference>
  <reference>
    <citation>Teasdale JD, Cox SG. Dysphoria: self-devaluative and affective components in recovered depressed patients and never depressed controls. Psychol Med. 2001 Oct;31(7):1311-6. doi: 10.1017/s003329170100424x.</citation>
    <PMID>11681557</PMID>
  </reference>
  <reference>
    <citation>Gayner B, Esplen MJ, DeRoche P, Wong J, Bishop S, Kavanagh L, Butler K. A randomized controlled trial of mindfulness-based stress reduction to manage affective symptoms and improve quality of life in gay men living with HIV. J Behav Med. 2012 Jun;35(3):272-85. doi: 10.1007/s10865-011-9350-8. Epub 2011 May 20.</citation>
    <PMID>21597980</PMID>
  </reference>
  <reference>
    <citation>Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013 Aug;69(8):856-67. doi: 10.1002/jclp.22021. Epub 2013 Jun 17.</citation>
    <PMID>23775511</PMID>
  </reference>
  <reference>
    <citation>Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.</citation>
    <PMID>3397865</PMID>
  </reference>
  <reference>
    <citation>Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.</citation>
    <PMID>15333231</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56.</citation>
    <PMID>7966923</PMID>
  </reference>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.</citation>
    <PMID>17339617</PMID>
  </reference>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.</citation>
    <PMID>11914441</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mental health</keyword>
  <keyword>mindfulness</keyword>
  <keyword>shame</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02987582
org study id: EFM 1
nct id: NCT02987582
lead sponsor: 
collaborator: 
has dmc: No
Living with symptoms of mental illness is associated with psychosocial impairment as it can
      affect someone's ability to work, their relationships and level of functioning. This also has
      high economic costs on a societal level. It has been shown that an increase in
      self-compassion may result in a secondary benefit of reducing psychological distress, which
      could offer substantial benefits. There is little empirical data on Emotion Focused
      Mindfulness (EFM) interventions for the population we are studying. This study aims to
      address this gap in the literature and practice, thus advancing the field.
Study Design

      The proposed study is a non-controlled, open-label, repeated measures intervention study. It
      is a two year feasibility study.

      Procedure:

      Recruitment

      Participants will be recruited through the Mount Sinai Academic Family Health Team. Patients
      who experience symptoms of depression and/or anxiety, may be referred by any member of the
      family health team, self-referrals through the family health team will also be accepted.
      Patients will be screened for eligibility for the EFM Group by the group facilitators.
      Patients may participate in the EFM group and refuse to participate in the research study.

      When patients agree to participate in the group intervention, patients will then be asked
      about interest in participating in this research. Group facilitators will provide details
      about the study. Interested patients are given the consent form to review. The group
      facilitator leaves the room and the research associate will then come into the room to obtain
      written consent.

      Intervention

      The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through
      the intervention there will be a 5 hour retreat on the weekend. A typical group format
      includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then
      group members will have time to report on recollections from meditation and facilitators will
      provide feedback. There is a break and the second part of the group focuses on a didactic
      teaching topic. Topics change each week. EFM groups will run between September 2016 and June
      2018.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Self-Compassion Scale (SCS) to assess change between baseline, midpoint, group completion and 2 months post group.
time frame: Weeks 1, 4, 8 and 2 months post group completion
description: 26 question self-administered questionnaire
measure: Positive and Negative Affect Scale (PANAS) to assess change between baseline, midpoint, group completion and 2 months post group.
time frame: Weeks 1, 4, 8 and 2 months post group completion
description: 20 item self-report measure of positive and negative affect
measure: Patient Health Questionnaire - Somatic Anxiety Depression Scale (PHQ-SADS) to assess change between baseline, midpoint, group completion and 2 months post group.
time frame: Weeks 1, 4, 8 and 2 months post group completion
description: Self-report scales that include the 9 questions for assessing depression; 7 questions for assessing general anxiety; and 15 questions for assessing somatic symptoms
measure: Internalized Shame Scale to assess change between baseline, midpoint, group completion and 2 months post group.
time frame: Weeks 1, 4, 8 and 2 months post group completion
description: 30 item self-report scale that measures the phenomenology of the shame experience
measure: World Health Organization Disability Assessment Schedule (WHODAS) to assess change between baseline, midpoint, group completion and 2 months post group.
time frame: Weeks 1, 4, 8 and 2 months post group completion
description: 12 item generic assessment instrument for health and disability
arm group label: Emotion-focused mindfulness group
arm group type: Experimental
description: 8-week mindfulness group
intervention type: Behavioral
intervention name: Emotion-focused mindfulness group
description: Intervention The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week; groups will run between October 2016 and June 2018.
arm group label: Emotion-focused mindfulness group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodelyn Wisco, MSW
role: Principal Investigator
affiliation: Mount Sinai Hospital, Sinai Health System
facility: 
country: Canada
url: http://www.camh.ca/en/hospital/about_camh/newsroom/for_reporters/Pages/addictionmentalhealthstatistics.aspx
description: Centre for Addiction and Mental Health. Mental Illness and Addictions: Facts and Statistics
url: http://www.nice.org.uk/guidance/cg90
description: National Institute for Health and Care Excellence. Depression in adults: recognition and management.
url: http://www.who.int/classifications/icf/more_whodas/en/
description: WHO. WHO Disability Assessment Schedule 2.0
url: https://ww1.cpa-apc.org/Publications/Position_Papers/Shared.asp
description: Canadian Psychiatric Association and The College of Family Physicians of Canada
url: https://books.google.ca/books?id=G0ITeV5CJYoC&pg=PA3&lpg=PA3&dq=80%25+primary+care+exclusive+mental+health&source=bl&ots=a1CDlNe1A3&sig=GWf-zOJ9V5fbmpFCpNAUl3qQy94&hl=en&sa=X&ved=0ahUKEwiYya3S-KjQAhVjqFQKHW0-DYgQ6AEILTAC#v=onepage&q=80%25%20primary%20care%20exclusive%20mental%20health&f=false
description: Behavioral Medicine: A Primary Care Approach
citation: Kessler RC, Gruber M, Hettema JM, Hwang I, Sampson N, Yonkers KA. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008 Mar;38(3):365-74. doi: 10.1017/S0033291707002012. Epub 2007 Nov 30.
PMID: 18047766
citation: Patten SB, Gordon-Brown L, Meadows G. Simulation studies of age-specific lifetime major depression prevalence. BMC Psychiatry. 2010 Oct 20;10:85. doi: 10.1186/1471-244X-10-85.
PMID: 20961404
citation: Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.
PMID: 25431430
citation: Canadian Psychiatric Association. Clinical practice guidelines. Management of anxiety disorders. Can J Psychiatry. 2006 Jul;51(8 Suppl 2):9S-91S. No abstract available. Erratum In: Can J Psychiatry. 2006 Sep;51(10):623.
PMID: 16933543
citation: Parikh SV, Segal ZV, Grigoriadis S, Ravindran AV, Kennedy SH, Lam RW, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. II. Psychotherapy alone or in combination with antidepressant medication. J Affect Disord. 2009 Oct;117 Suppl 1:S15-25. doi: 10.1016/j.jad.2009.06.042. Epub 2009 Aug 13.
PMID: 19682749
citation: Teasdale JD, Cox SG. Dysphoria: self-devaluative and affective components in recovered depressed patients and never depressed controls. Psychol Med. 2001 Oct;31(7):1311-6. doi: 10.1017/s003329170100424x.
PMID: 11681557
citation: Gayner B, Esplen MJ, DeRoche P, Wong J, Bishop S, Kavanagh L, Butler K. A randomized controlled trial of mindfulness-based stress reduction to manage affective symptoms and improve quality of life in gay men living with HIV. J Behav Med. 2012 Jun;35(3):272-85. doi: 10.1007/s10865-011-9350-8. Epub 2011 May 20.
PMID: 21597980
citation: Germer CK, Neff KD. Self-compassion in clinical practice. J Clin Psychol. 2013 Aug;69(8):856-67. doi: 10.1002/jclp.22021. Epub 2013 Jun 17.
PMID: 23775511
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PMID: 3397865
citation: Crawford JR, Henry JD. The positive and negative affect schedule (PANAS): construct validity, measurement properties and normative data in a large non-clinical sample. Br J Clin Psychol. 2004 Sep;43(Pt 3):245-65. doi: 10.1348/0144665031752934.
PMID: 15333231
citation: Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56.
PMID: 7966923
citation: Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
PMID: 17339617
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
PMID: 11914441
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No