Trauma, PsychologicalST-HANCT04466163
Strengthening the Healthy Adult Mode: a Case Experimental Study Exploring the Effects of a New Schema Therapy Protocol in an Adult Outpatient Population.
A study testing Schema Therapy and the Healthy Adult in people with Trauma, Psychological and Personality Disorders, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Psychological, Personality Disorders, Chronic Psychiatric Disorder
- What is being tested?
- Schema Therapy and the Healthy Adult
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Schema Therapy and the Healthy Adult
- Keywords
- Schema Therapy, Positive Psychology, Self-compassion, Personality disorder, Well-being, Positive Affect, Healthy Adult mode
- Medical subject headings
- Psychological Trauma, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema Therapy and the Healthy AdultBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Schema Therapy and the Healthy Adult | Experimental | 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 Receives: Behavioral: Schema Therapy and the Healthy Adult |
| Baseline | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: daily during baseline (14-35 days) and intervention (10 weeks), one week after 1 month/3 months
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).
Measured: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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).
Measured: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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).
Measured: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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).
Measured: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Schema Modes (Change)
Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).
Measured: 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.
Positive Affect (Change)
Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).
Measured: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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.
Measured: Momentary SMI: weekly during baseline (up to 14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Secondary outcomes (1)
Symptomatic distress (Change)
Symptomatic distress will be measured by the Outcome Questionnaire-45 (OQ-45; De Jong et al., 2007; Lambert et al., 2004).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Sep 2020
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Versluis, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466163
- Sponsor's protocol ID
- ST-HA
- Acronym
- ST-HA
- Status last verified
- Jan 2022
- First submitted
- 29 Jun 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04466163
- Acronym / sponsor ID
- ST-HA / ST-HA
- Keywords
- Schema Therapy, Positive Psychology, Self-compassion, Personality disorder, Well-being, Positive Affect, Healthy Adult mode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Schema Therapy and the Healthy Adult | Experimental | Behavioral: Schema Therapy and the Healthy AdultFor 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 |
| Baseline | No intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schema Therapy and the Healthy AdultThe 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. | Behavioural | Schema Therapy and the Healthy Adult |
Primary outcome
Diary: Healthy Adult Functioning change
Time frame: daily during baseline (14-35 days) and intervention (10 weeks), one week after 1 month/3 months
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)
Time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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)
Time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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)
Time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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)
Time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
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)
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.
Adaptive schema modes will be measured with the Schema Modi Inventory (SMI; Young et al., 2007).
Positive Affect (Change)
Time frame: weekly during baseline (14-35 days) & intervention period (10 weeks), 1 month follow-up, 3 month follow-up
Positive affect will be measured by the Positive Affect Subscale (PA) of the PANAS (Watson et al., 1988).
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
Also, the Momentary Schema Mode Inventory, adapted from the SMI for weekly assessment of modes (Roelofs et al., 2016) will be used.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: Yes
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Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
RecruitingPhase 3
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
PTSD, Post Traumatic Stress Disorder, Moral Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema Therapy and the Healthy Adult in people with Trauma, Psychological and Personality Disorders, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.