Clinical trial NCT04770038: Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response
Official title: Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Personality Disorder (BPD)
Keywords: social integration
Borderline Personality Disorder
treatment response
psychiatric inpatient treatment
fMRI
negative social bias
social touch
interoception
trust
Dialectical Behavior Therapy
Lead sponsor: University of Oldenburg
Sponsor class: OTHER
Collaborators: name: Prof. René Hurlemann
name: Jella Voelter, M.Sc.
First posted: 2021-02-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: BPD patients are recruited from a waiting list for DBT inpatient treatment and directly during inpatient treatment at the University Clinic for Psychiatry and Psychotherapy, Karl-Jaspers-Klinik, Bad Zwischenahn, Germany.

Group 2: Healthy participants are recruited via the notice board of the University of Oldenburg, and, in order to achieve a more heterogenous sample, via online advertisments

Brief summary: The present longitudinal study aims at (i) identifying neurobiological mechanisms associated with successful social integration during the treatment of inpatients with Borderline Personality Disorder (BPD) and (ii) improving biomarker-based predictions of treatment response by incorporating core metrics of social integration.

Detailed description: Social connections have a strong impact on mental and physical health. Surprisingly, however, there is a paucity of studies probing the predictive validity of perceived social connections such as subjective social support and loneliness for the outcomes of inpatient treatment of BPD. Although social impairments are key features of BPD psychopathology, social integration has been largely neglected, which may therefore explain the minimal translation of predictive molecular or imaging-based biomarkers into the clinic. The investigators hypothesize that the assessment of negative cognitive biases at baseline will help to identify BPD patients who will experience less social support and more loneliness during inpatient treatment. Furthermore, an inclusion of social integration indices may increase the incremental validity for the biomarker-based prediction of treatment response.

In this longitudinal, observational study, data from 56 BPD patients will be analyzed to assess negative cognitive biases and the underlying neurobiological mechanisms with behavioral, neuroendocrine, psychophysiological, and neural readouts before and after one month of inpatient Dialectical Behavior Therapy (DBT). To evaluate pathological biases, the patients' data will be compared with a control group of 31 healthy participants who will also be tested twice. Neural readouts include structural and functional magnetic resonance imaging (fMRI) measurements. The fMRI tasks will probe the processing of social touch, interpersonal trust, and interoception. To further investigate pathological distortions of social touch and interoception, interoceptive accuracy and comfort zones of social touch will be assessed. Further, patients and healthy participants will perform a positive social interaction task, accompanied by psychophysiological and neuroendocrinological measures. Psychometric questionnaires and semi-structured interviews will be used to monitor symptom load and social indices before, during, and after the inpatient treatment. Long-term effects will be assessed by questionnaires and interviews 8 and 20 weeks after inpatient treatment/waiting time, as well as after each DBT module (follow-ups). The investigators plan to conduct uni- and multivariate analyses of the baseline measurements to predict patients' social integration and treatment response during the inpatient therapy and examine treatment-related changes. The findings of this project may help identify vulnerable patients that benefit from adjunct therapies targeting negative social biases and improve biomarker-based models of treatment prediction.

Eligibility criteria: Inclusion Criteria:

* Willingness / ability to give written informed consent to participate in the study
* BPD patients: on a waiting list for DBT, BPD as primary diagnosis
* Healthy participants: free of current physical or psychiatric illness
* Fluent in German

Exclusion Criteria:

* Contraindication for MRI investigation (e.g. agoraphobia, pacemaker, pregnancy)
* Acute suicidality, current substance dependence or primary psychotic disorder
* A history of head trauma or neurological illness
* Scars on a predefined skin area (approx. 20 cm) of the shins
* Healthy participants: current or past psychiatric inpatient treatment

Primary outcomes:
measure: Social integration during inpatient treatment as measured by questionnaires and interviews
timeFrame: Social integration (duration approx. 30-45 minutes) will be measured continuously during inpatient treatment (twice a week for four weeks).
measure: Changes in neural responses to interpersonal touch
timeFrame: The fMRI task (duration approx. 15 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in comfort ratings of interpersonal touch in the fMRI task
timeFrame: The fMRI task (duration approx. 15 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in neural responses in the Trust Game
timeFrame: The fMRI task (duration approx. 6 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in interpersonal trust
timeFrame: The fMRI task (duration approx. 6 minutes) will be performed before and after one month of inpatient DBT /waiting time.
measure: Changes in neural responses during an interoception task
timeFrame: The fMRI task (duration approx. 13 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in intensity ratings of bodily awareness in the fMRI task
timeFrame: The fMRI task (duration approx. 13 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in interoceptive accuracy as measured by a heartbeat discrimination task
timeFrame: Interoceptive accuracy (duration approx. 20 minutes) will be assessed before and after one month of inpatient DBT/waiting time.
measure: Changes in interoceptive sensibility as measured with a questionnaire
timeFrame: Interoceptive sensibility (duration approx. 5 minutes) will be measured before and after one month of inpatient DBT/waiting time.
measure: Changes in psychophysiological measures during a positive social interaction
timeFrame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
measure: Changes in hormone and enzyme salivary concentrations in response to a positive social interaction
timeFrame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
measure: Changes in mood in response to a social interaction
timeFrame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
measure: Changes in bodily maps of social touch
timeFrame: The bodily maps (duration approx. 10-15 minutes) will be assessed before and after 4-weeks DBT treatment/waiting time.
measure: Changes in attitude towards social touch
timeFrame: Self-reported touch preferences (duration approx. 5 minutes) will be assessed before and after one month of inpatient DBT/waiting time as well as during follow-up measurements.
measure: Changes in negative social biases
timeFrame: Questionnaires (duration approx. 15-20 minutes) will be measured before and after one month of inpatient DBT/waiting time as well as during follow-up measurements.
measure: Changes in symptom load
timeFrame: Symptom load (duration approx. 30-45 minutes) will be measured before and after one month of inpatient DBT, continuously during therapy (twice a week for four weeks) as well as during follow-up measurements.
Secondary outcomes:
measure: Changes in neural activity at resting state
timeFrame: Resting State (duration approx. 10 minutes) will be performed before and after one month of inpatient DBT/waiting time.
measure: Changes in vigilance
timeFrame: Vigilance (duration approx. 5 minutes) will be measured one week before and after one month of inptatient DBT/waiting time.
measure: Childhood maltreatment
timeFrame: The CTQ (duration approx. 5 minutes) will be performed before one month of inpatient DBT/waiting time.
measure: Changes in symptom load of possible comorbidities
timeFrame: Symptom load (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT treatment/waiting time as well as during follow-up measurements.
measure: Changes in personality traits
timeFrame: Personality traits (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT/waiting time.
measure: Psychotherapy outcome as measured with a questionnaire
timeFrame: Psychotherapy outcome (duration approx. 5 minutes) will be measured after one month of inpatient DBT.
measure: Verbal intelligence
timeFrame: Verbal intelligence (duration approx. 5 minutes) will be measured before one month of inpatient DBT/waiting time.
Other outcomes:
Locations:
city: Bad Zwischenahn
country: Germany
facility: Department of Psychiatry, University of Oldenburg, Karl-Jaspers-Klinik
Study officials:
affiliation: Ruhr University of Bochum, Germany
name: Dirk Scheele, Prof.
role: PRINCIPAL_INVESTIGATOR
References: