Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response (SANITY)

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.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder (BPD)
• Intervention / Treatment: Behavioral: Dialectical Behavior Therapy (DBT)

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, 60 BPD patients will be recruited to assess negative cognitive biases and the underlying neurobiological mechanisms with behavioral, neuroendocrine, psychophysiological, and neural readouts before and after a four-week inpatient treatment. To evaluate pathological biases, the patients' data will be compared with a control group of 30 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 (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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Dirk Scheele, PhD; Phone Number: 1508 +49 441 9615; Email: Dirk.Scheele@uol.de
• Study Contact Backup: Name: Jella Voelter; Phone Number: 1503 +49 441 9615; Email: Jella.Voelter@uol.de

Study Locations

• Germany
  • Bad Zwischenahn, Germany, 26160
    • Recruiting
    • Department of Psychiatry, University of Oldenburg, Karl-Jaspers-Klinik
    • Contact: Dirk Scheele, PhD; Phone Number: 1508 +49 441 9615; Email: Dirk.Scheele@uol.de
    • Sub-Investigator: René Hurlemann, Prof.
    • Sub-Investigator: Jella Voelter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group 1: BPD patients are recruited from a waiting list for Dialectical Behavior Therapy (DBT) as well as during inpatient treatment at the Department of Psychiatry, University of Oldenburg, Karl-Jaspers-Klinik, 26160 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

Description

Inclusion Criteria:

• Willingness / ability to give written informed consent to participate in the study
• BPD inpatient treatment
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Group; 60 BPD patients	Behavioral: Dialectical Behavior Therapy (DBT); Evidence-based psychotherapy for the treatment of Borderline Personality Disorder
Control Group; 30 Healthy participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social integration during inpatient treatment as measured by questionnaires and interviews	Social integration will be assessed with questionnaires and interviews (e.g. the perceived social support questionnaire).	Social integration (duration approx. 30-45 minutes) will be measured continuously during inpatient treatment (twice a week for four weeks).
Changes in neural responses to interpersonal touch	Blood-oxygen-level-dependent (BOLD) signal will be assessed while participants undergo a social touch task. Conditions consist of four types of touch trials with combinations of slow (~ 5 cm/s) and fast touch (~ 20 cm/s), as well as social (administered by hand) and non-social (administered with a brush) touch and a control (no touch) condition. An experimenter, who cannot be seen by the participant, will administer the touch across 20 cm of the shins. After each trial, participants will be asked to rate how comforting the touch was perceived. The neural responses to interpersonal touch will be compared before and after DBT-treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 15 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in comfort ratings of interpersonal touch in the fMRI task	During the social touch fMRI task, participants rate the comfort of the tactile stimuli (including the no touch condition) on a visual analogue scale. The behavioral data will be analyzed and linked to the BOLD signal. Comfort ratings will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 15 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in neural responses in the Trust Game	BOLD signal will be measured while participants play a single-round trust game in the role of an investor. Participants will have to decide how much money they want to invest in an unknown trustee without receiving feedback about the decisions of the trustees. In a control condition, participants will play a risk game and invest money in a computer, which will randomly decide whether the money will be shared. The neural correlates will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 6 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in interpersonal trust	During the fMRI Trust Game, participants will decide how much (from 1 Euro to 10 Euro) they want to invest in the unknown trustees on a visual analog scale (VAS). Furthermore, participants will rate the facial trustworthiness of the face stimuli used in the fMRI Trust Game. These behavioral data will be analyzed and linked to the BOLD signal. The behavioral data will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 6 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in neural responses during an interoception task	During the interoception fMRI task, participants are instructed to focus on their heartbeat, their stomach, or color changes of the word "target" (as control). After every second trial, participants rate how intensely they perceived their heartbeat or their stomach. During the control condition, participants indicate how intensely they perceived the color change. The neural correlates will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 13 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in intensity ratings of bodily awareness in the fMRI task	During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on VAS. The behavioral data will be analyzed and linked to the BOLD signal. Intensity ratings will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The fMRI task (duration approx. 13 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in interoceptive accuracy as measured by a heartbeat discrimination task	During the heartbeat discrimination task, participants have to indicate, whether a series of tones is presented synchronously or asynchronously to their own heartbeat. In addition, they rate their confidence on their own assessment on a VAS. Interoceptive accuracy will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Interoceptive accuracy (duration approx. 20 minutes) will be assessed before and after 4-weeks DBT treatment/waiting time.
Changes in interoceptive sensibility as measured with a questionnaire	The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) will be used to measure self-reported interoceptive sensibility. Questionnaire scores will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Interoceptive sensibility (duration approx. 5 minutes) will be measured one week before and after 4-weeks DBT treatment/waiting time.
Changes in psychophysiological measures during a positive social interaction	The positive social interaction will consist of a semi-structured ten-minute conversation between the participant and a same-sex unfamiliar experimenter. After a baseline measurement of five minutes, participants will talk about plans for a fictive lottery win and hobbies and interests. During the baseline, as well as during the conversation, psychophysiological parameters of both, the participant and the experimenter, will be measured simultaneously.	The positive social interaction (duration approx. 15 minutes) will be conducted one week before 4-weeks DBT treatment/waiting time
Changes in hormone and enzyme salivary concentrations in response to a positive social interaction	Saliva samples will be collected before, immediately after, and 15 minutes after the social interaction task.	The positive social interaction (duration approx. 15 minutes) will be conducted one week before 4-weeks DBT treatment/waiting time
Changes in mood in response to a social interaction	Mood state will be assessed with questionnaires (e.g. the Profile of Mood States (POMS)).	The positive social interaction (duration approx. 15 minutes) will be conducted one week before 4-weeks DBT treatment/waiting time
Changes in bodily maps of social touch	In a computerized task, participants will indicate on a human silhouette, where a specific person (e.g. their mother) would be allowed to touch them in everyday situations. Comfort zones of social touch for different members of their social network (e.g. brother, female stranger etc.) will be analyzed. Bodily maps will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	The bodily maps (duration approx. 10-15 minutes) will be assessed one week before and after 4-weeks DBT treatment/waiting time.
Changes in attitude towards social touch	The attitude towards social touch will be measured by the Social Touch Questionnaire (STQ). Self-reported touch preferences will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Self-reported touch preferences (duration approx. 5 minutes) will be assessed before and after 4-weeks DBT treatment/waiting time.
Changes in negative social biases	Negative social biases will be assessed with questionnaires (e.g. the University of California Los Angeles (UCLA) Loneliness Scale). Questionnaire scores will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Questionnaires (duration approx. 15-20 minutes) will be measured before and after 4-weeks DBT treatment/waiting time as well as during follow-up measurements 8 and 20 weeks after DBT treatment/waiting time.
Changes in symptom load	Symptom load will be assessed with questionnaires and interviews (e.g. the Borderline-Symptom-List-23 (BSL-23)). Symptom load will be compared before and after the DBT treatment and will be measured continuously during DBT treatment.	Symptom load (duration approx. 30-45 minutes) will be measured one week before and after 4-weeks DBT treatment, continuously during therapy (twice a week for four weeks) as well as during follow-up measurements 8 and 20 weeks after DBT-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in neural activity at resting state	fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open. Participants will be instructed to look at a fixation cross for ~ 10 minutes. The neural correlates will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Resting State (duration approx. 10 minutes) will be performed one week before and after 4-weeks DBT treatment/waiting time.
Changes in vigilance	Vigilance will measured with the Psychomotor Vigilance Task (PVT). The PVT is a reaction time task in which participants respond to visual stimuli via button presses. Participants fixate a black screen and press a button as soon as a digital clock with a running time-measurement appears on screen. Vigilance will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Vigilance (duration approx. 5 minutes) will be measured one week before and after 4-weeks DBT treatment/waiting time.
Childhood maltreatment	The Childhood Trauma Questionnaire (CTQ) will be used to measure childhood maltreatment. The scale ranges between 5 and 100 points and higher scores indicate higher childhood maltreatment.	The CTQ (duration approx. 5 minutes) will be used one week before 4-weeks DBT treatment/waiting time.
Changes in symptom load of possible comorbidities	Symptom load will be assessed with questionnaires (e.g. the Becks-Depression-Inventory-II (BDI-II)). Questionnaire scores will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Symptom load (duration approx. 10 minutes) will be measured one week before and after 4-weeks DBT treatment/waiting time as well as during follow-up measurements 8 and 20 weeks after DBT treatment.
Changes in personality traits	The big five personality traits will be measured with the NEO-Five-Factor-Inventory (NEO-FFI). Personality traits will be compared before and after the DBT treatment and the treatment-induced changes will be compared with changes in the healthy control group.	Personality traits (duration approx. 10 minutes) will be measured one week before and after 4-weeks DBT treatment/waiting time.
Psychotherapy outcome as measured with a questionnaire	Psychotherapy outcome will be assessed with the Bochum Change Questionnaire 2000 (BCQ-2000).	Psychotherapy outcome (duration approx. 5 minutes) will be measured one week after 4-weeks DBT treatment.
Verbal intelligence	Verbal intelligence will be measured with the Multiple Choice Vocabulary Test (MWT-B)	Verbal intelligence (duration approx. 5 minutes) will be measured one week before 4-weeks DBT treatment/waiting time.

Collaborators and Investigators

• Sponsor: University of Oldenburg
• Collaborators: Prof. René Hurlemann; Jella Voelter, M.Sc.
• Investigators: Principal Investigator: Dirk Scheele, PhD, University Hospital Bonn, Germany. University of Oldenburg, Germany.

Publications and helpful links

Helpful Links

• Research group website
• Research group website

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: fMRI; Borderline Personality Disorder; treatment response; social touch; social integration; interoception; trust; psychiatric inpatient treatment; biomarker-based prediction; negative social bias
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: SANITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No