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

NCT04466163 | Completed

• 1 other identifier: ST-HA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Psychological; Personality Disorders; Chronic Psychiatric Disorder

Keywords

Schema Therapy; Positive Psychology; Self-compassion; Personality disorder; Well-being; Positive Affect; Healthy Adult mode

Outcome Measures

Primary Outcomes (8)

• 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.

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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)

  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

Study Arms (2)

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

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

Interventions

Schema Therapy and the Healthy Adult BEHAVIORAL

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.

Schema Therapy and the Healthy Adult

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland MC

Sittard, Limburg, 6162BG, Netherlands

Location

MeSH Terms

Conditions

Psychological Trauma; Personality Disorders

Interventions

Schema Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Healthcare Psychologist, Clinical Psychologist in training

Model Details: 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).

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 10, 2020
• Study Start: September 1, 2020
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Jan. 2022 (6 months)

Locations

NL (1)