xml: <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/NCT06038747</url>
    </required_header>
    <id_info>
      <org_study_id>23-1067</org_study_id>
      <nct_id>NCT06038747</nct_id>
    </id_info>
    <brief_title>Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.</brief_title>
    <official_title>Investigating the Impact of Regular Self-monitoring and Reflecting on Affective Reactions Toward the Psychotherapist on Treatment Outcomes: A Randomized Controlled Trial Protocol.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pavia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Commission</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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 primary objective of this randomized controlled trial is to examine the influence of a&#xD;
        brief post-session battery, designed to foster patient self-monitoring and reflection on&#xD;
        their emotional reactions toward their psychotherapist, on the quality of the therapeutic&#xD;
        relationship and treatment outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The quality of the therapeutic relationship is critical in determining psychotherapy&#xD;
        outcomes. However, facilitating patients' self-awareness and reflection on their affective&#xD;
        responses to their therapist remains understudied as a potential tool for enhancing this&#xD;
        relationship and subsequent treatment outcomes. The primary objective of this study is to&#xD;
        examine the influence of a brief post-session battery, designed to foster patient&#xD;
        self-monitoring and reflection on their emotional reactions toward their psychotherapist, on&#xD;
        the quality of the therapeutic relationship and treatment outcomes. Using an observational&#xD;
        randomized control trial design, participants will be allocated into intervention and control&#xD;
        groups. Those in the intervention group will complete a postsession battery following each&#xD;
        therapy session, while the control group will only undergo regular treatment. Data collection&#xD;
        will be facilitated through the Qualtrics online survey software and span baseline, mid-trial&#xD;
        (5th week), and end-of-trial (10th week) assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Randomized controlled trial design. Allocation ratio of 1:1.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 5 weeks</measure>
      <time_frame>Baseline, 5 weeks</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 10 weeks</measure>
      <time_frame>Baseline, 10 weeks</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from 5 weeks to 10 weeks</measure>
      <time_frame>5 weeks, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 5 weeks</measure>
      <time_frame>Baseline, 5 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 10 weeks</measure>
      <time_frame>Baseline, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks</measure>
      <time_frame>5 weeks, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 5 weeks</measure>
      <time_frame>Baseline, 5 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 10 weeks</measure>
      <time_frame>Baseline, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from 5 weeks to 10 weeks</measure>
      <time_frame>5 weeks, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 5 weeks</measure>
      <time_frame>Baseline, 5 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 10 weeks</measure>
      <time_frame>Baseline, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from 5 weeks to 10 weeks</measure>
      <time_frame>5 weeks, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 5 weeks</measure>
      <time_frame>Baseline, 5 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 10 weeks</measure>
      <time_frame>Baseline, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from 5 weeks to 10 weeks</measure>
      <time_frame>5 weeks, 10 weeks.</time_frame>
      <description>Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Real Relationship Inventory-Client-Short form (Total score)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. Total score ranges 0-40. Higher scores represent better quality of the real relationship. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Real Relationship Inventory-Client-Short form (Genuineness)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Genuineness subscale (3 items) score ranges 0-20. Higher scores represent higher perceived genuineness. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Real Relationship Inventory-Client-Short form (Realism)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Realism subscale (4 items) score range 0-20. Higher scores represent higher perceived realism. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory-Short Revised (Total score)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance and includes three subscales: goal, task, and bond. Total score ranges 0-72. Higher scores indicate a stronger alliance. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory-Short Revised (Goal)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Goal subscale (3 items) score ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory-Short Revised (Task)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Task subscale score (3 items) ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Working Alliance Inventory-Short Revised (Bond)</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Bond subscale score (3 items) ranges 0-18. Higher scores indicate a stronger affective bond between the patient and the therapist. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of sessions missed or canceled</measure>
      <time_frame>Up to 10 weeks.</time_frame>
      <description>Number of scheduled psychotherapy sessions that have been missed or canceled by the participant. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Psychotherapy</condition>
    <condition>Therapeutic Alliance</condition>
    <condition>Psychological</condition>
    <arm_group>
      <arm_group_label>Individual Psychotherapy + Self-Monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will continue their regular individual psychotherapy sessions. Additionally, after each session, they will complete a brief postsession battery consisting of two scales on the affective reactions of the participants towards their therapist during session and read general feedback encouraging them to discuss their feelings and reflections with their therapist. This questionnaire aims to prompt reflection on the own experience of the therapeutic relationship.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Individual Psychotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the control group will receive only treatment as usual (i.e., individual psychotherapy) sand and will not complete post-session questionnaires. Additionally, they will not receive any feedback at all encouraging them to discuss their emotional responses with their therapist during the session.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Self-Monitoring</intervention_name>
      <description>The post-session battery consists of two self-report scales measuring both positive and negative affective reactions of the participants toward their therapist during the therapy session. The general feedback is a brief text that encourages participants to share and discuss their feelings and reflections with their therapist.</description>
      <arm_group_label>Individual Psychotherapy + Self-Monitoring</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Individual Psychotherapy</intervention_name>
      <description>Individual psychotherapy sessions</description>
      <arm_group_label>Individual Psychotherapy</arm_group_label>
      <arm_group_label>Individual Psychotherapy + Self-Monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being aged 18 years or older,&#xD;
  &#xD;
            -  being fluent in English,&#xD;
  &#xD;
            -  being currently under individual psychotherapy with a minimum frequency of two&#xD;
               sessions per month.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having a legal guardian.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alberto Stefana, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alberto Stefana, PhD</last_name>
      <phone>+393381131304</phone>
      <email>astefana@unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric A Youngstrom, PhD</last_name>
      <email>eay@unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Researchforme.Unc.Edu</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alberto Stefana, PhD</last_name>
        <email>astefana@unc.edu</email>
      </contact>
      <investigator>
        <last_name>Alberto Stefana, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eric Youngstrom, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Researchmatch.Org</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27599</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Alberto Stefana, PhD</last_name>
        <email>astefana@unc.edu</email>
      </contact>
      <investigator>
        <last_name>Alberto Stefana, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eric A Youngstrom, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Therapeutic Relationship</keyword>
    <keyword>Routine Outcome Monitoring</keyword>
    <keyword>Self-Monitoring and Reflection</keyword>
    <keyword>Psychotherapy Outcome</keyword>
    <keyword>Client Feedback</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The Study protocol article will be published before data collection completion. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following the publication of the research reports.</ipd_time_frame>
      <ipd_access_criteria>Investigator has approved IRB, IEC), or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038747
  org study id: 23-1067
  nct id: NCT06038747
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this randomized controlled trial is to examine the influence of a
        brief post-session battery, designed to foster patient self-monitoring and reflection on
        their emotional reactions toward their psychotherapist, on the quality of the therapeutic
        relationship and treatment outcomes.
  The quality of the therapeutic relationship is critical in determining psychotherapy
        outcomes. However, facilitating patients' self-awareness and reflection on their affective
        responses to their therapist remains understudied as a potential tool for enhancing this
        relationship and subsequent treatment outcomes. The primary objective of this study is to
        examine the influence of a brief post-session battery, designed to foster patient
        self-monitoring and reflection on their emotional reactions toward their psychotherapist, on
        the quality of the therapeutic relationship and treatment outcomes. Using an observational
        randomized control trial design, participants will be allocated into intervention and control
        groups. Those in the intervention group will complete a postsession battery following each
        therapy session, while the control group will only undergo regular treatment. Data collection
        will be facilitated through the Qualtrics online survey software and span baseline, mid-trial
        (5th week), and end-of-trial (10th week) assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial design. Allocation ratio of 1:1.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 5 weeks
  time frame: Baseline, 5 weeks
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 10 weeks
  time frame: Baseline, 10 weeks
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from 5 weeks to 10 weeks
  time frame: 5 weeks, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 5 weeks
  time frame: Baseline, 5 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 10 weeks
  time frame: Baseline, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks
  time frame: 5 weeks, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 5 weeks
  time frame: Baseline, 5 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 10 weeks
  time frame: Baseline, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from 5 weeks to 10 weeks
  time frame: 5 weeks, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 5 weeks
  time frame: Baseline, 5 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 10 weeks
  time frame: Baseline, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from 5 weeks to 10 weeks
  time frame: 5 weeks, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 5 weeks
  time frame: Baseline, 5 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 10 weeks
  time frame: Baseline, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.
  measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from 5 weeks to 10 weeks
  time frame: 5 weeks, 10 weeks.
  description: Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.
  measure: Real Relationship Inventory-Client-Short form (Total score)
  time frame: Up to 10 weeks.
  description: Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. Total score ranges 0-40. Higher scores represent better quality of the real relationship. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Real Relationship Inventory-Client-Short form (Genuineness)
  time frame: Up to 10 weeks.
  description: Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Genuineness subscale (3 items) score ranges 0-20. Higher scores represent higher perceived genuineness. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Real Relationship Inventory-Client-Short form (Realism)
  time frame: Up to 10 weeks.
  description: Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Realism subscale (4 items) score range 0-20. Higher scores represent higher perceived realism. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Working Alliance Inventory-Short Revised (Total score)
  time frame: Up to 10 weeks.
  description: Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance and includes three subscales: goal, task, and bond. Total score ranges 0-72. Higher scores indicate a stronger alliance. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Working Alliance Inventory-Short Revised (Goal)
  time frame: Up to 10 weeks.
  description: Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Goal subscale (3 items) score ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Working Alliance Inventory-Short Revised (Task)
  time frame: Up to 10 weeks.
  description: Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Task subscale score (3 items) ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Working Alliance Inventory-Short Revised (Bond)
  time frame: Up to 10 weeks.
  description: Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Bond subscale score (3 items) ranges 0-18. Higher scores indicate a stronger affective bond between the patient and the therapist. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  measure: Number of sessions missed or canceled
  time frame: Up to 10 weeks.
  description: Number of scheduled psychotherapy sessions that have been missed or canceled by the participant. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).
  arm group label: Individual Psychotherapy + Self-Monitoring
  arm group type: Experimental
  description: Participants in the intervention group will continue their regular individual psychotherapy sessions. Additionally, after each session, they will complete a brief postsession battery consisting of two scales on the affective reactions of the participants towards their therapist during session and read general feedback encouraging them to discuss their feelings and reflections with their therapist. This questionnaire aims to prompt reflection on the own experience of the therapeutic relationship.
  arm group label: Individual Psychotherapy
  arm group type: Active Comparator
  description: Participants in the control group will receive only treatment as usual (i.e., individual psychotherapy) sand and will not complete post-session questionnaires. Additionally, they will not receive any feedback at all encouraging them to discuss their emotional responses with their therapist during the session.
  intervention type: Other
  intervention name: Self-Monitoring
  description: The post-session battery consists of two self-report scales measuring both positive and negative affective reactions of the participants toward their therapist during the therapy session. The general feedback is a brief text that encourages participants to share and discuss their feelings and reflections with their therapist.
  arm group label: Individual Psychotherapy + Self-Monitoring
  intervention type: Other
  intervention name: Individual Psychotherapy
  description: Individual psychotherapy sessions
  arm group label: Individual Psychotherapy
  arm group label: Individual Psychotherapy + Self-Monitoring
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alberto Stefana, PhD
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Alberto Stefana, PhD
  phone: +393381131304
  email: astefana@unc.edu
  last name: Eric A Youngstrom, PhD
  email: eay@unc.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  facility: 
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  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The Study protocol article will be published before data collection completion. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following the publication of the research reports.
  ipd access criteria: Investigator has approved IRB, IEC), or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.