<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/NCT04466163</url>
  </required_header>
  <id_info>
    <org_study_id>ST-HA</org_study_id>
    <nct_id>NCT04466163</nct_id>
  </id_info>
  <brief_title>Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population.</brief_title>
  <acronym>ST-HA</acronym>
  <official_title>Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zuyderland Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zuyderland Medisch Centrum</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>
      Background: Strengthening the Healthy Adult schema mode is the ultimate goal in Schema&#xD;
      Therapy, working as an assumed mechanism of long-term change through improved positive mental&#xD;
      health. Evidence-based interventions to directly strengthen this Healthy Adult mode are&#xD;
      sparse.&#xD;
&#xD;
      Objective: To study the feasibility, acceptability and effectiveness of the treatment&#xD;
      protocol 'Schema Therapy and the Healthy Adult' (ST-HA) during the final stage of schema&#xD;
      therapy in adult outpatients with personality- or chronic psychopathology. Method: In this&#xD;
      study a single case experimental design (n = 8) with multiple measures will be used, to&#xD;
      determine the effects of the ST-HA protocol on self-compassion, well-being, positive affect&#xD;
      and Healthy Adult functioning. For each participant a no-treatment randomized baseline period&#xD;
      (2-5 weeks) will be compared with treatment (ST-HA, 10 weekly sessions) and post-treatment&#xD;
      follow-up (at 1- and 3-months). Assessments include brief diaries regarding self-compassion&#xD;
      and Healthy Adult functioning (daily from baseline to end of intervention, and 7-days at 1-&#xD;
      and 3-months follow-up) and standardized questionnaires for measuring weekly changes in&#xD;
      self-compassion, well-being and adaptive schema modes. During phase changes additional&#xD;
      measures of trait self-compassion, positive affect, adaptive schema modes and symptomatic&#xD;
      distress will be administered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schema therapy (ST; Young, 1990, Young et al., 2003) is an effective treatment for&#xD;
      personality disorders and other chronic psychopathology, leading to significant improvement&#xD;
      in functioning in most patients. The model of psychopathology that underlies ST is based on&#xD;
      the assumption that when core emotional needs - especially those related to attachment&#xD;
      stability - are insufficiently met in childhood, there is an increased chance that&#xD;
      long-standing patterns of maladaptive thinking, feeling, behaving and coping (called schemas)&#xD;
      will develop (i.e. Hawke &amp; Provencher, 2011; Flink et al., 2019; Lockwood &amp; Peris, 2012).&#xD;
      When schemas are activated, the individual switches into a specific&#xD;
      emotional-cognitive-behavioral state, called schema mode.&#xD;
&#xD;
      Schema therapy formulated in mode terms aims to build a Healthy Adult mode in patients by&#xD;
      correcting dysfunctional self-representations which originate from unmet childhood needs&#xD;
      (child modes), thereby replacing internalized critic modes with adaptive coping behavior&#xD;
      (e.g. Arntz &amp; Jacob, 2012; Claassen &amp; Pol, 2013, 2014; Lobbestael et al., 2007; Young et al.,&#xD;
      2003). This healthy, adultlike part of the self helps patients to meet their emotional needs&#xD;
      and seems related to a longer-term view of emotional well-being (Roediger, Stevens, &amp;&#xD;
      Brockman, 2018). Recent studies demonstrate that building the Healthy Adult mode is crucial&#xD;
      for long-term outcomes in patients with schema-driven perception and behavior, working as a&#xD;
      mechanism of change through improved positive emotion regulation strategies to cope with&#xD;
      (childhood) adversity (Louis et al., 2018; Westerhof &amp; Wolterink, 2018; Yakin et al., 2020).&#xD;
      A more explicit focus on healthy emotional functioning and regulation within ST seems&#xD;
      therefore important. One useful emotional-approach coping strategy associated with healthy&#xD;
      adult functioning is self-compassion (Trompetter et al., 2016; Yakin et al., 2019).&#xD;
      Self-compassion is defined as being kind toward oneself (Neff, 2003b) and being able to use&#xD;
      self-reassurance and soothing when presented with negative affect or adversities (Gilbert,&#xD;
      2010; Gilbert et al., 2017; Kirschner et al. 2019). It is facilitated by early experiences of&#xD;
      care and warmth from an attachment ﬁgure, which contributed to a sense of safeness in which&#xD;
      individuals develop a soothing-affective system (Brophy et al., 2020; Gilbert, 2014; Gilbert&#xD;
      &amp; Proctor, 2006; Mackintosh et al., 2018). This system exerts its protective function by&#xD;
      stimulating physiological processes associated with stress reduction and positive affiliation&#xD;
      affects (i.e. feeling loved, safe and securely attached) (Depue &amp; Morrone-Strupinsky, 2005;&#xD;
      Engen &amp; Singer, 2015; Porges, 2007). Promoting the soothing-affective system subsequently&#xD;
      helps reducing threat-related negative emotional states and excessive drive-related arousal&#xD;
      (i.e. activation of dysfunctional schema modes) by increasing compassionate self-reassuring&#xD;
      abilities, which are characterized by a caring, warm, and accepting attitude toward the self&#xD;
      (Gilbert, 2010; Petrocchi et al., 2019; Thimm, 2017). Self-compassion therefore increases&#xD;
      positive self, while reducing negative self (Mackintosch et al., 2018; Kirschner et al. 2019)&#xD;
      via addressing dysfunctional schema modes. That is, the healthy side of patients is aware of&#xD;
      self-undermining messages, can challenge them, hereby reducing their impact by practicing&#xD;
      self-compassion with focus on attunement to emotional needs. Self-compassion and the ability&#xD;
      to cultivate positive emotions in ourselves can thus be viewed as strategy to 'broaden- and&#xD;
      build' healthy adult behavior (Fredrickson, 2001). Positive emotions allow us to discard&#xD;
      habitual modes and instead look for flexible, new ways of thinking and acting (Fredrickson,&#xD;
      2003, 2004; Fredrickson et al., 2008). This broadened mindset can accumulate and compound to&#xD;
      build biological (e.g. cardiac vagal tone) as well as cognitive (e.g. mindfulness), social&#xD;
      (e.g. positive relations) and psychological (e.g. life-purpose) resources (Cloninger, 2006;&#xD;
      Cloninger &amp; Zohar, 2011). Experiencing positive emotions subsequently increases functional&#xD;
      coping in a needs-based, value-driven, flexible way, serving as 'compass' for healthy adult&#xD;
      behavior over lifetime (Bahner, 2016; Deci &amp; Ryan, 2000; Plumb et al., 2009; Schreurs &amp;&#xD;
      Westerhof, 2013).&#xD;
&#xD;
      Against this background, interventions focusing on the integration of schema therapy and&#xD;
      compassion based therapy seems promising. To our best knowledge the protocol 'Schematherapy&#xD;
      and the Healthy Adult' (ST-HA, Broersen &amp; Claassen, 2019) is the first direct intervention&#xD;
      meant to strengthen patients' healthy adult functioning by developing compassion and care for&#xD;
      well-being in the face of (childhood) adversity. The current study explores the&#xD;
      effectiveness, acceptability and feasibility of the ST-HA protocol in adult outpatients with&#xD;
      personality- or chronic psychopathology during final stage ST, in which there is a focus on&#xD;
      positive mental health, resilience and preparing therapy termination. It is hypothesized that&#xD;
      administering the ST-HA protocol: (1) will increase self-compassion, well-being, positive&#xD;
      affect and adaptive schema modes over the intervention and follow-up period, measured by&#xD;
      daily diary data and standardized measurements; (2) will be accompanied by self-reported&#xD;
      symptom-reduction over the intervention and follow-up period; and (3) will be acceptable and&#xD;
      feasible in adult outpatients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">January 25, 2022</completion_date>
  <primary_completion_date type="Actual">January 25, 2022</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>In this study a single case experimental design (n = 8) with multiple measures will be used, to determine the effects of the ST-HA protocol on self-compassion, well-being, positive affect and Healthy Adult functioning. For each participant a no-treatment randomized baseline period (2-5 weeks) will be compared with treatment (ST-HA, 10 weekly sessions) and post-treatment follow-up (at 1- and 3-months).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diary: Healthy Adult Functioning change</measure>
    <time_frame>daily during baseline (14-35 days) and intervention (10 weeks), one week after 1 month/3 months</time_frame>
    <description>To check change in self-reported self-compassion a diary will be used consisting of a subset of seven items measuring compassionate affect, reasoning and behavior selected from standardized questionnaires with visual analog scales (VAS) (Morley, 2017; see: Vlaeyen et al., 2001). Five items adapted from the Safe/Content Affect Scale (Gilbert et al., 2008), will ask patients about their soothing affiliative affect (i.e. feeling safe, secure, content, warm). Two items ask patients about state self-reassuring and -kindness and are adopted from the Self-Compassion Scale (SCS; Neff, 2003a; see Kirschner et al., 2019). The three last diary items represent patient-generated goals, referring to personally relevant self-caring and supportive Healthy Adult behaviors. These personalized items can include healthy attitudes, choices, preferences and opportunities, that patients are willing to engage in.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State Self-Compassion (Change)</measure>
    <time_frame>weekly during baseline (14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>State self-compassion will be measured by the State Self-Compassion Scale - Short Form (SSCS-SF; Neff et al., submitted). Participants are instructed to think about a situation that they are experiencing right now, that is painful or difficult. Participants subsequently have to indicate how well each of six statements applies to how they are feeling toward themselves right now as they think about this situation on a five point scale, ranging from 1 ('not at all true for me') to 5 ('very true for me'). The SSCS-SF is a valid and reliable measure of state self-compassion (Neff et al., submitted).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trait Self-Compassion (Change)</measure>
    <time_frame>weekly during baseline (14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>Trait self-compassion will be measured by the 12-item short form of the Self-Compassion Scale (SCS-SF; Raes et al., 2010).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Criticism and Self-Reassuring (Change)</measure>
    <time_frame>weekly during baseline (14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>Self-criticism and self-reassurance and will be measured by the Forms of Self-Criticism/-Reassurance Subscales- Short form (FSCRS-SF; Sommers-Spijkerman et al., 2018).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Well-being (Change)</measure>
    <time_frame>weekly during baseline (14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>Well-being will be measured by the Mental Health Continuum-Short Form (MHC-SF; Lamers et al., 2011), a 14-item self-report questionnaire covering three core components of well-being: (1) emotional wellbeing, deﬁned in terms of positive feelings (e.g. happiness and positive affect) and satisfaction with life (three items); (2) psychological wellbeing; deﬁned in terms of positive functioning in individual life (e.g. feelings of self-acceptance, environmental mastery, purpose in life, positive social relationships) (six items) and (3) social wellbeing, deﬁned in terms of positive functioning in community life (e.g. feelings of social contribution, social acceptance, and social integration) (ﬁve items).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schema Modes (Change)</measure>
    <time_frame>SMI: start baseline (week 0), start intervention (after 14-35 days of baseline), after 10 weeks of intervention, 1 month follow-up, 3 month follow-up.</time_frame>
    <description>Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Affect (Change)</measure>
    <time_frame>weekly during baseline (14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Momentary Schema Mode Inventory (Change)</measure>
    <time_frame>Momentary SMI: weekly during baseline (up to 14-35 days) &amp; intervention period (10 weeks), 1 month follow-up, 3 month follow-up</time_frame>
    <description>Also, the Momentary Schema Mode Inventory, adapted from the SMI for weekly assessment of modes (Roelofs et al., 2016) will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptomatic distress (Change)</measure>
    <time_frame>5 timepoints (start baseline (week 0), start intervention (after 14-35 days of baseline), after 10 weeks of intervention, 1 month follow-up, 3 months follow-up</time_frame>
    <description>Symptomatic distress will be measured by the Outcome Questionnaire-45 (OQ-45; De Jong et al., 2007; Lambert et al., 2004).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Trauma, Psychological</condition>
  <condition>Personality Disorders</condition>
  <condition>Chronic Psychiatric Disorder</condition>
  <arm_group>
    <arm_group_label>Schema Therapy and the Healthy Adult</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For this study the ST-HA protocol outlined by Broersen &amp; Claassen (2019) will be followed, consisting of ten one-and-a-half hour individual sessions across ten weeks with daily homework assignments (30-60 minutes). The ST-HA protocol is based on three pillars, aimed at improving self-compassion, well-being and positive affect. First psycho-education about compassionate affect regulation is given and patients learn to recognize the importance of self-caring behavior in stimulating the soothing- affect system to buffer against stress. The second pillar of the ST-HA protocol concerns the development of personal values and committed action as well as getting insight in values of important others. The third pillar concerns developing self-compassion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Outcome variables will be measured repeatedly in a pre-treatment baseline condition (2-5 weeks). Patients are randomly assigned to a pre-treatment/baseline phase. In the present study a restricted randomisation is chosen (Heyvaert &amp; Onghena, 2014a). A minimum length of the phases is decided a priori in order to prevent for the assignment of too few measurements per phase and to ensure that the full treatment protocol can be offered</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Schema Therapy and the Healthy Adult</intervention_name>
    <description>The protocol 'Schematherapy and the Healthy Adult' (ST-HA, Broersen &amp; Claassen, 2019) is a direct intervention meant to strengthen patients' healthy adult functioning by developing compassion and care for well-being in the face of (childhood) adversity.</description>
    <arm_group_label>Schema Therapy and the Healthy Adult</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 18 to 65 year&#xD;
&#xD;
          -  a diagnosis of personality disorder and/or (comorbid) persistent mood-/somatic symptom&#xD;
             disorder according to DSM-5 at the start of regular group or individual ST;&#xD;
&#xD;
          -  following final stage individual or group ST (as indicated by the patients' certified&#xD;
             Schema Therapist). If ST is terminated, this must be within four months before&#xD;
             starting with current ST-HA study;&#xD;
&#xD;
          -  suboptimal positive mental health as indicated by low to moderate levels of&#xD;
             well-being, determined by the Mental Health Continuum&#xD;
&#xD;
          -  Short Form (MHC-SF; Keyes, 2002; Lamers et al., 2011) or below average to low scores&#xD;
             on the Positive Affect scale of the Positive And Negative Affect Schedule (PANAS;&#xD;
             Watson et al., 1988);&#xD;
&#xD;
          -  self-reported motivation for a 10-session psychological intervention focusing on&#xD;
             positive mental health;&#xD;
&#xD;
          -  have access to a computer or tablet with a good Internet connection;&#xD;
&#xD;
          -  possess an e-mail address;&#xD;
&#xD;
          -  have sufficient proficiency of the Dutch language (reading and writing);&#xD;
&#xD;
          -  provided informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric disorders: acute suicidal risk, a psychotic and/or bipolar&#xD;
             disorder, schizophrenia, delirium, dementia of severe cognitive impairment;&#xD;
&#xD;
          -  ongoing other ST/psychological treatment during the baseline and treatment phase;&#xD;
&#xD;
          -  former treatment based on the ST-HA protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zuyderland MC</name>
      <address>
        <city>Sittard</city>
        <state>Limburg</state>
        <zip>6162BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zuyderland Medisch Centrum</investigator_affiliation>
    <investigator_full_name>Yvonne Versluis</investigator_full_name>
    <investigator_title>Healthcare Psychologist, Clinical Psychologist in training</investigator_title>
  </responsible_party>
  <keyword>Schema Therapy</keyword>
  <keyword>Positive Psychology</keyword>
  <keyword>Self-compassion</keyword>
  <keyword>Personality disorder</keyword>
  <keyword>Well-being</keyword>
  <keyword>Positive Affect</keyword>
  <keyword>Healthy Adult mode</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
    <mesh_term>Psychological Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Jan. 2022 (6 months)</ipd_time_frame>
  </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/NCT04466163
org study id: ST-HA
nct id: NCT04466163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Strengthening the Healthy Adult schema mode is the ultimate goal in Schema
      Therapy, working as an assumed mechanism of long-term change through improved positive mental
      health. Evidence-based interventions to directly strengthen this Healthy Adult mode are
      sparse.

      Objective: To study the feasibility, acceptability and effectiveness of the treatment
      protocol 'Schema Therapy and the Healthy Adult' (ST-HA) during the final stage of schema
      therapy in adult outpatients with personality- or chronic psychopathology. Method: In this
      study a single case experimental design (n = 8) with multiple measures will be used, to
      determine the effects of the ST-HA protocol on self-compassion, well-being, positive affect
      and Healthy Adult functioning. For each participant a no-treatment randomized baseline period
      (2-5 weeks) will be compared with treatment (ST-HA, 10 weekly sessions) and post-treatment
      follow-up (at 1- and 3-months). Assessments include brief diaries regarding self-compassion
      and Healthy Adult functioning (daily from baseline to end of intervention, and 7-days at 1-
      and 3-months follow-up) and standardized questionnaires for measuring weekly changes in
      self-compassion, well-being and adaptive schema modes. During phase changes additional
      measures of trait self-compassion, positive affect, adaptive schema modes and symptomatic
      distress will be administered.
Schema therapy (ST; Young, 1990, Young et al., 2003) is an effective treatment for
      personality disorders and other chronic psychopathology, leading to significant improvement
      in functioning in most patients. The model of psychopathology that underlies ST is based on
      the assumption that when core emotional needs - especially those related to attachment
      stability - are insufficiently met in childhood, there is an increased chance that
      long-standing patterns of maladaptive thinking, feeling, behaving and coping (called schemas)
      will develop (i.e. Hawke & Provencher, 2011; Flink et al., 2019; Lockwood & Peris, 2012).
      When schemas are activated, the individual switches into a specific
      emotional-cognitive-behavioral state, called schema mode.

      Schema therapy formulated in mode terms aims to build a Healthy Adult mode in patients by
      correcting dysfunctional self-representations which originate from unmet childhood needs
      (child modes), thereby replacing internalized critic modes with adaptive coping behavior
      (e.g. Arntz & Jacob, 2012; Claassen & Pol, 2013, 2014; Lobbestael et al., 2007; Young et al.,
      2003). This healthy, adultlike part of the self helps patients to meet their emotional needs
      and seems related to a longer-term view of emotional well-being (Roediger, Stevens, &
      Brockman, 2018). Recent studies demonstrate that building the Healthy Adult mode is crucial
      for long-term outcomes in patients with schema-driven perception and behavior, working as a
      mechanism of change through improved positive emotion regulation strategies to cope with
      (childhood) adversity (Louis et al., 2018; Westerhof & Wolterink, 2018; Yakin et al., 2020).
      A more explicit focus on healthy emotional functioning and regulation within ST seems
      therefore important. One useful emotional-approach coping strategy associated with healthy
      adult functioning is self-compassion (Trompetter et al., 2016; Yakin et al., 2019).
      Self-compassion is defined as being kind toward oneself (Neff, 2003b) and being able to use
      self-reassurance and soothing when presented with negative affect or adversities (Gilbert,
      2010; Gilbert et al., 2017; Kirschner et al. 2019). It is facilitated by early experiences of
      care and warmth from an attachment ﬁgure, which contributed to a sense of safeness in which
      individuals develop a soothing-affective system (Brophy et al., 2020; Gilbert, 2014; Gilbert
      & Proctor, 2006; Mackintosh et al., 2018). This system exerts its protective function by
      stimulating physiological processes associated with stress reduction and positive affiliation
      affects (i.e. feeling loved, safe and securely attached) (Depue & Morrone-Strupinsky, 2005;
      Engen & Singer, 2015; Porges, 2007). Promoting the soothing-affective system subsequently
      helps reducing threat-related negative emotional states and excessive drive-related arousal
      (i.e. activation of dysfunctional schema modes) by increasing compassionate self-reassuring
      abilities, which are characterized by a caring, warm, and accepting attitude toward the self
      (Gilbert, 2010; Petrocchi et al., 2019; Thimm, 2017). Self-compassion therefore increases
      positive self, while reducing negative self (Mackintosch et al., 2018; Kirschner et al. 2019)
      via addressing dysfunctional schema modes. That is, the healthy side of patients is aware of
      self-undermining messages, can challenge them, hereby reducing their impact by practicing
      self-compassion with focus on attunement to emotional needs. Self-compassion and the ability
      to cultivate positive emotions in ourselves can thus be viewed as strategy to 'broaden- and
      build' healthy adult behavior (Fredrickson, 2001). Positive emotions allow us to discard
      habitual modes and instead look for flexible, new ways of thinking and acting (Fredrickson,
      2003, 2004; Fredrickson et al., 2008). This broadened mindset can accumulate and compound to
      build biological (e.g. cardiac vagal tone) as well as cognitive (e.g. mindfulness), social
      (e.g. positive relations) and psychological (e.g. life-purpose) resources (Cloninger, 2006;
      Cloninger & Zohar, 2011). Experiencing positive emotions subsequently increases functional
      coping in a needs-based, value-driven, flexible way, serving as 'compass' for healthy adult
      behavior over lifetime (Bahner, 2016; Deci & Ryan, 2000; Plumb et al., 2009; Schreurs &
      Westerhof, 2013).

      Against this background, interventions focusing on the integration of schema therapy and
      compassion based therapy seems promising. To our best knowledge the protocol 'Schematherapy
      and the Healthy Adult' (ST-HA, Broersen & Claassen, 2019) is the first direct intervention
      meant to strengthen patients' healthy adult functioning by developing compassion and care for
      well-being in the face of (childhood) adversity. The current study explores the
      effectiveness, acceptability and feasibility of the ST-HA protocol in adult outpatients with
      personality- or chronic psychopathology during final stage ST, in which there is a focus on
      positive mental health, resilience and preparing therapy termination. It is hypothesized that
      administering the ST-HA protocol: (1) will increase self-compassion, well-being, positive
      affect and adaptive schema modes over the intervention and follow-up period, measured by
      daily diary data and standardized measurements; (2) will be accompanied by self-reported
      symptom-reduction over the intervention and follow-up period; and (3) will be acceptable and
      feasible in adult outpatients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study a single case experimental design (n = 8) with multiple measures will be used, to determine the effects of the ST-HA protocol on self-compassion, well-being, positive affect and Healthy Adult functioning. For each participant a no-treatment randomized baseline period (2-5 weeks) will be compared with treatment (ST-HA, 10 weekly sessions) and post-treatment follow-up (at 1- and 3-months).
primary purpose: Treatment
masking: None (Open Label)
measure: Diary: Healthy Adult Functioning change
time frame: daily during baseline (14-35 days) and intervention (10 weeks), one week after 1 month/3 months
description: To check change in self-reported self-compassion a diary will be used consisting of a subset of seven items measuring compassionate affect, reasoning and behavior selected from standardized questionnaires with visual analog scales (VAS) (Morley, 2017; see: Vlaeyen et al., 2001). Five items adapted from the Safe/Content Affect Scale (Gilbert et al., 2008), will ask patients about their soothing affiliative affect (i.e. feeling safe, secure, content, warm). Two items ask patients about state self-reassuring and -kindness and are adopted from the Self-Compassion Scale (SCS; Neff, 2003a; see Kirschner et al., 2019). The three last diary items represent patient-generated goals, referring to personally relevant self-caring and supportive Healthy Adult behaviors. These personalized items can include healthy attitudes, choices, preferences and opportunities, that patients are willing to engage in.
measure: State Self-Compassion (Change)
time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: State self-compassion will be measured by the State Self-Compassion Scale - Short Form (SSCS-SF; Neff et al., submitted). Participants are instructed to think about a situation that they are experiencing right now, that is painful or difficult. Participants subsequently have to indicate how well each of six statements applies to how they are feeling toward themselves right now as they think about this situation on a five point scale, ranging from 1 ('not at all true for me') to 5 ('very true for me'). The SSCS-SF is a valid and reliable measure of state self-compassion (Neff et al., submitted).
measure: Trait Self-Compassion (Change)
time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: Trait self-compassion will be measured by the 12-item short form of the Self-Compassion Scale (SCS-SF; Raes et al., 2010).
measure: Self-Criticism and Self-Reassuring (Change)
time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: Self-criticism and self-reassurance and will be measured by the Forms of Self-Criticism/-Reassurance Subscales- Short form (FSCRS-SF; Sommers-Spijkerman et al., 2018).
measure: Well-being (Change)
time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: Well-being will be measured by the Mental Health Continuum-Short Form (MHC-SF; Lamers et al., 2011), a 14-item self-report questionnaire covering three core components of well-being: (1) emotional wellbeing, deﬁned in terms of positive feelings (e.g. happiness and positive affect) and satisfaction with life (three items); (2) psychological wellbeing; deﬁned in terms of positive functioning in individual life (e.g. feelings of self-acceptance, environmental mastery, purpose in life, positive social relationships) (six items) and (3) social wellbeing, deﬁned in terms of positive functioning in community life (e.g. feelings of social contribution, social acceptance, and social integration) (ﬁve items).
measure: Schema Modes (Change)
time frame: SMI: start baseline (week 0), start intervention (after 14-35 days of baseline), after 10 weeks of intervention, 1 month follow-up, 3 month follow-up.
description: Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).
measure: Positive Affect (Change)
time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).
measure: Momentary Schema Mode Inventory (Change)
time frame: Momentary SMI: weekly during baseline (up to 14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
description: Also, the Momentary Schema Mode Inventory, adapted from the SMI for weekly assessment of modes (Roelofs et al., 2016) will be used.
measure: Symptomatic distress (Change)
time frame: 5 timepoints (start baseline (week 0), start intervention (after 14-35 days of baseline), after 10 weeks of intervention, 1 month follow-up, 3 months follow-up
description: Symptomatic distress will be measured by the Outcome Questionnaire-45 (OQ-45; De Jong et al., 2007; Lambert et al., 2004).
arm group label: Schema Therapy and the Healthy Adult
arm group type: Experimental
description: For this study the ST-HA protocol outlined by Broersen & Claassen (2019) will be followed, consisting of ten one-and-a-half hour individual sessions across ten weeks with daily homework assignments (30-60 minutes). The ST-HA protocol is based on three pillars, aimed at improving self-compassion, well-being and positive affect. First psycho-education about compassionate affect regulation is given and patients learn to recognize the importance of self-caring behavior in stimulating the soothing- affect system to buffer against stress. The second pillar of the ST-HA protocol concerns the development of personal values and committed action as well as getting insight in values of important others. The third pillar concerns developing self-compassion
arm group label: Baseline
arm group type: No Intervention
description: Outcome variables will be measured repeatedly in a pre-treatment baseline condition (2-5 weeks). Patients are randomly assigned to a pre-treatment/baseline phase. In the present study a restricted randomisation is chosen (Heyvaert & Onghena, 2014a). A minimum length of the phases is decided a priori in order to prevent for the assignment of too few measurements per phase and to ensure that the full treatment protocol can be offered
intervention type: Behavioral
intervention name: Schema Therapy and the Healthy Adult
description: The protocol 'Schematherapy and the Healthy Adult' (ST-HA, Broersen & Claassen, 2019) is a direct intervention meant to strengthen patients' healthy adult functioning by developing compassion and care for well-being in the face of (childhood) adversity.
arm group label: Schema Therapy and the Healthy Adult
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Zuyderland Medisch Centrum
investigator full name: Yvonne Versluis
investigator title: Healthcare Psychologist, Clinical Psychologist in training
mesh term: Personality Disorders
mesh term: Mental Disorders
mesh term: Problem Behavior
mesh term: Psychological Trauma
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Jan. 2022 (6 months)