Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response

NCT04770038 | Completed

• 1 other identifier: SANITY
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (16)

• 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 before and after one month of inpatient DBT/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 trial on a Visual Analogue Scale (VAS). 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 before and after one month of inpatient DBT/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 before and after one month of inpatient DBT/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 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 before and after one month of inpatient DBT /waiting time.

• Changes in neural responses during an interoception task

  During the interoception fMRI task, participants are instructed to focus on their heart, their stomach, or color changes of the word "target" (as control). After every second trial, participants rate how intensely they perceived their heart 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 before and after one month of inpatient DBT/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 heart 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 before and after one month of inpatient DBT/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 one month of inpatient DBT/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 before and after one month of inpatient DBT/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 before one month of inpatient DBT/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 before one month of inpatient DBT/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 before one month of inpatient DBT/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 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 one month of inpatient DBT/waiting time as well as during follow-up measurements.

• 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 one month of inpatient DBT/waiting time as well as during follow-up measurements.

• 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 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 (7)

• Changes in neural activity at resting state

  Resting State (duration approx. 10 minutes) will be performed before and after one month of inpatient DBT/waiting time.

• Changes in vigilance

  Vigilance (duration approx. 5 minutes) will be measured one week before and after one month of inptatient DBT/waiting time.

• Childhood maltreatment

  The CTQ (duration approx. 5 minutes) will be performed before one month of inpatient DBT/waiting time.

• Changes in symptom load of possible comorbidities

  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.

• Changes in personality traits

  Personality traits (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT/waiting time.

Study Arms (2)

Patient Group

56 BPD patients

Behavioral: Dialectical Behavior Therapy (DBT)

Control Group

31 Healthy participants

Interventions

Dialectical Behavior Therapy (DBT) BEHAVIORAL

Evidence-based psychotherapy for the treatment of Borderline Personality Disorder

Patient Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oldenburg: lead
• Prof. René Hurlemann: collaborator
• Jella Voelter, M.Sc.: collaborator

Study Sites (1)

Department of Psychiatry, University of Oldenburg, Karl-Jaspers-Klinik

Bad Zwischenahn, 26160, Germany

Location

Related Links

• Research group website
• Research group website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples to measure cortisol, oxytocin and alpha-amylase.

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dirk Scheele, Prof.

  Ruhr University of Bochum, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 25, 2021
• Study Start: February 10, 2021
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

DE (1)