<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/NCT01695252</url>
  </required_header>
  <id_info>
    <org_study_id>GN12CP071</org_study_id>
    <secondary_id>CZH/4/708</secondary_id>
    <nct_id>NCT01695252</nct_id>
  </id_info>
  <brief_title>Measuring and Monitoring Patient Informed Clinical Outcomes In Psychological Therapy Supervision</brief_title>
  <acronym>MEMOS</acronym>
  <official_title>Measuring and Monitoring Patient Informed Clinical Outcomes In Psychological Therapy Supervision - A Stepped Wedge Cluster Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      Providing feedback on patient progress to therapists improves clinical outcomes for patients,&#xD;
      particularly those who are failing to improve with therapy. The encouraging research has been&#xD;
      carried out by a small group of researchers, largely working in the United States health care&#xD;
      context. The samples studied have been young people attending university counselling&#xD;
      services, suffering from mild mental health disorders. The group studies are therefore not&#xD;
      similar to patients seen for psychological therapy in the NHS. Also given that therapists are&#xD;
      not necessarily alert to treatment failure, have an overly optimistic view of their patients&#xD;
      progress even when provided with evidence to the contrary, clinical supervision may be a more&#xD;
      effective method through which to provide patient informed clinical outcomes than directly to&#xD;
      therapists themselves.&#xD;
&#xD;
      We will assess if providing feedback through the supervision process is more effective than&#xD;
      providing this information to therapists themselves in terms of improving clinical outcomes,&#xD;
      particularly for patients who are failing to improve with routine NHS Psychological therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Overall CORE-OM score</measure>
    <description>Change from baseline at discharge and 6 months follow-up in the primary outcome will be compared between the supervision groups using a repeated measure analysis with appropriate correlation structure, including a random effect for therapist and fixed effects for baseline overall CORE-OM score and any other appropriate demographics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CORE 10</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">470</enrollment>
  <condition>Patients Referred for Routine Psychological Therapy</condition>
  <arm_group>
    <arm_group_label>S-Sup</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard supervision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEMOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient informed clinical outcomes supervision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MEMOS</intervention_name>
    <description>Patient informed clinical outcomes supervision</description>
    <arm_group_label>MEMOS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
        Able to give informed consent Male or female (&gt;18 years of age) Requiring psychological&#xD;
        treatment or therapy in routine Mental Health Services Able and competent to understand and&#xD;
        complete CORE questionnaires&#xD;
&#xD;
        Supervisors and their therapists&#xD;
&#xD;
        Able to give written informed consent Any NHS Greater Glasgow and Clyde applied&#xD;
        psychologist who is supervising therapists offering routine psychological therapy to&#xD;
        patients in NHS Greater Glasgow and Clyde and whose therapists agree to take part in the&#xD;
        study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
        Below the age of 18 years Inability to give written informed consent Inability to&#xD;
        understand and complete CORE questionnaires&#xD;
&#xD;
        Supervisors and their therapists&#xD;
&#xD;
        Those supervisors and therapists who are unlikely to be able to stay in the study for its&#xD;
        duration.&#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>Kate M Davidson, MA MPhil PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Greater Glasgow and Clyde</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Davidson KM, Rankin ML, Begley A, Lloyd S, Barry SJ, McSkimming P, Bell L, Allan C, Osborne M, Ralston G, Bienkowski G, Mellor-Clark J, Walker A. Assessing Patient Progress in Psychological Therapy Through Feedback in Supervision: the MeMOS* Randomized Controlled Trial (*Measuring and Monitoring clinical Outcomes in Supervision: MeMOS). Behav Cogn Psychother. 2017 May;45(3):209-224. doi: 10.1017/S1352465817000029. Epub 2017 Feb 7.</citation>
    <PMID>28166849</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NHS Greater Glasgow and Clyde</investigator_affiliation>
    <investigator_full_name>Professor Kate Davidson</investigator_full_name>
    <investigator_title>Director of Glasgow Institute of Psychological Interventions</investigator_title>
  </responsible_party>
  <!-- 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/NCT01695252
org study id: GN12CP071
secondary id: CZH/4/708
nct id: NCT01695252
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Providing feedback on patient progress to therapists improves clinical outcomes for patients,
      particularly those who are failing to improve with therapy. The encouraging research has been
      carried out by a small group of researchers, largely working in the United States health care
      context. The samples studied have been young people attending university counselling
      services, suffering from mild mental health disorders. The group studies are therefore not
      similar to patients seen for psychological therapy in the NHS. Also given that therapists are
      not necessarily alert to treatment failure, have an overly optimistic view of their patients
      progress even when provided with evidence to the contrary, clinical supervision may be a more
      effective method through which to provide patient informed clinical outcomes than directly to
      therapists themselves.

      We will assess if providing feedback through the supervision process is more effective than
      providing this information to therapists themselves in terms of improving clinical outcomes,
      particularly for patients who are failing to improve with routine NHS Psychological therapy.
As above
allocation: Randomized
primary purpose: Treatment
measure: Overall CORE-OM score
description: Change from baseline at discharge and 6 months follow-up in the primary outcome will be compared between the supervision groups using a repeated measure analysis with appropriate correlation structure, including a random effect for therapist and fixed effects for baseline overall CORE-OM score and any other appropriate demographics.
measure: CORE 10
arm group label: S-Sup
arm group type: No Intervention
description: Standard supervision
arm group label: MEMOS
arm group type: Experimental
description: Patient informed clinical outcomes supervision
intervention type: Other
intervention name: MEMOS
description: Patient informed clinical outcomes supervision
arm group label: MEMOS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kate M Davidson, MA MPhil PhD
role: Principal Investigator
affiliation: NHS Greater Glasgow and Clyde
facility: 
country: United Kingdom
citation: Davidson KM, Rankin ML, Begley A, Lloyd S, Barry SJ, McSkimming P, Bell L, Allan C, Osborne M, Ralston G, Bienkowski G, Mellor-Clark J, Walker A. Assessing Patient Progress in Psychological Therapy Through Feedback in Supervision: the MeMOS* Randomized Controlled Trial (*Measuring and Monitoring clinical Outcomes in Supervision: MeMOS). Behav Cogn Psychother. 2017 May;45(3):209-224. doi: 10.1017/S1352465817000029. Epub 2017 Feb 7.
PMID: 28166849
responsible party type: Principal Investigator
investigator affiliation: NHS Greater Glasgow and Clyde
investigator full name: Professor Kate Davidson
investigator title: Director of Glasgow Institute of Psychological Interventions