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Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population. (ST-HA)

Primary Purpose

Trauma, Psychological, Personality Disorders, Chronic Psychiatric Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Schema Therapy and the Healthy Adult
Sponsored by
Zuyderland Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological focused on measuring Schema Therapy, Positive Psychology, Self-compassion, Personality disorder, Well-being, Positive Affect, Healthy Adult mode

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age of 18 to 65 year
  • a diagnosis of personality disorder and/or (comorbid) persistent mood-/somatic symptom disorder according to DSM-5 at the start of regular group or individual ST;
  • following final stage individual or group ST (as indicated by the patients' certified Schema Therapist). If ST is terminated, this must be within four months before starting with current ST-HA study;
  • suboptimal positive mental health as indicated by low to moderate levels of well-being, determined by the Mental Health Continuum
  • Short Form (MHC-SF; Keyes, 2002; Lamers et al., 2011) or below average to low scores on the Positive Affect scale of the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988);
  • self-reported motivation for a 10-session psychological intervention focusing on positive mental health;
  • have access to a computer or tablet with a good Internet connection;
  • possess an e-mail address;
  • have sufficient proficiency of the Dutch language (reading and writing);
  • provided informed consent.

Exclusion Criteria:

  • severe psychiatric disorders: acute suicidal risk, a psychotic and/or bipolar disorder, schizophrenia, delirium, dementia of severe cognitive impairment;
  • ongoing other ST/psychological treatment during the baseline and treatment phase;
  • former treatment based on the ST-HA protocol.

Sites / Locations

  • Zuyderland MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Schema Therapy and the Healthy Adult

Baseline

Arm 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

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

Outcomes

Primary Outcome Measures

Diary: Healthy Adult Functioning change
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.
State Self-Compassion (Change)
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).
Trait Self-Compassion (Change)
Trait self-compassion will be measured by the 12-item short form of the Self-Compassion Scale (SCS-SF; Raes et al., 2010).
Self-Criticism and Self-Reassuring (Change)
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).
Well-being (Change)
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).
Schema Modes (Change)
Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).
Positive Affect (Change)
Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).
Momentary Schema Mode Inventory (Change)
Also, the Momentary Schema Mode Inventory, adapted from the SMI for weekly assessment of modes (Roelofs et al., 2016) will be used.

Secondary Outcome Measures

Symptomatic distress (Change)
Symptomatic distress will be measured by the Outcome Questionnaire-45 (OQ-45; De Jong et al., 2007; Lambert et al., 2004).

Full Information

First Posted
June 29, 2020
Last Updated
January 24, 2022
Sponsor
Zuyderland Medisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT04466163
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.
Acronym
ST-HA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Personality Disorders, Chronic Psychiatric Disorder
Keywords
Schema Therapy, Positive Psychology, Self-compassion, Personality disorder, Well-being, Positive Affect, Healthy Adult mode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schema Therapy and the Healthy Adult
Arm Type
Experimental
Arm 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 Title
Baseline
Arm Type
No Intervention
Arm 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(s)
Schema Therapy and the Healthy Adult
Intervention 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.
Primary Outcome Measure Information:
Title
Diary: Healthy Adult Functioning change
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.
Time Frame
daily during baseline (14-35 days) and intervention (10 weeks), one week after 1 month/3 months
Title
State Self-Compassion (Change)
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).
Time Frame
weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Title
Trait Self-Compassion (Change)
Description
Trait self-compassion will be measured by the 12-item short form of the Self-Compassion Scale (SCS-SF; Raes et al., 2010).
Time Frame
weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Title
Self-Criticism and Self-Reassuring (Change)
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).
Time Frame
weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Title
Well-being (Change)
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).
Time Frame
weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Title
Schema Modes (Change)
Description
Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).
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.
Title
Positive Affect (Change)
Description
Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).
Time Frame
weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Title
Momentary Schema Mode Inventory (Change)
Description
Also, the Momentary Schema Mode Inventory, adapted from the SMI for weekly assessment of modes (Roelofs et al., 2016) will be used.
Time Frame
Momentary SMI: weekly during baseline (up to 14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Secondary Outcome Measure Information:
Title
Symptomatic distress (Change)
Description
Symptomatic distress will be measured by the Outcome Questionnaire-45 (OQ-45; De Jong et al., 2007; Lambert et al., 2004).
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age of 18 to 65 year a diagnosis of personality disorder and/or (comorbid) persistent mood-/somatic symptom disorder according to DSM-5 at the start of regular group or individual ST; following final stage individual or group ST (as indicated by the patients' certified Schema Therapist). If ST is terminated, this must be within four months before starting with current ST-HA study; suboptimal positive mental health as indicated by low to moderate levels of well-being, determined by the Mental Health Continuum Short Form (MHC-SF; Keyes, 2002; Lamers et al., 2011) or below average to low scores on the Positive Affect scale of the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988); self-reported motivation for a 10-session psychological intervention focusing on positive mental health; have access to a computer or tablet with a good Internet connection; possess an e-mail address; have sufficient proficiency of the Dutch language (reading and writing); provided informed consent. Exclusion Criteria: severe psychiatric disorders: acute suicidal risk, a psychotic and/or bipolar disorder, schizophrenia, delirium, dementia of severe cognitive impairment; ongoing other ST/psychological treatment during the baseline and treatment phase; former treatment based on the ST-HA protocol.
Facility Information:
Facility Name
Zuyderland MC
City
Sittard
State/Province
Limburg
ZIP/Postal Code
6162BG
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Jan. 2022 (6 months)

Learn more about this trial

Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population.

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