Borderline Personality Disorder (BPD)SANITYNCT04770038
Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response
An observational study of Borderline Personality Disorder (BPD), run by University of Oldenburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- Dialectical Behavior Therapy (DBT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2021to 21 Jan 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Oldenburg, Karl-Jaspers-Klinik
Bad Zwischenahn, 26160
About this study
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.
Read the 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.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- Dialectical Behavior Therapy (DBT)
- Keywords
- social integration, Borderline Personality Disorder, treatment response, psychiatric inpatient treatment, fMRI, negative social bias, social touch, interoception, trust, Dialectical Behavior Therapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior Therapy (DBT)Behavioural
Evidence-based psychotherapy for the treatment of Borderline Personality Disorder
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | 56 BPD patients Receives: Behavioral: Dialectical Behavior Therapy (DBT) | |
| Control Group | 31 Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Resting State (duration approx. 10 minutes) will be performed before and after one month of inpatient DBT/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.
Measured: Vigilance (duration approx. 5 minutes) will be measured one week before and after one month of inptatient DBT/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.
Measured: 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 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.
Measured: 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
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.
Measured: Personality traits (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT/waiting time.
Psychotherapy outcome as measured with a questionnaire
Psychotherapy outcome will be assessed with the Bochum Change Questionnaire 2000 (BCQ-2000).
Measured: Psychotherapy outcome (duration approx. 5 minutes) will be measured after one month of inpatient DBT.
Verbal intelligence
Verbal intelligence will be measured with the Multiple Choice Vocabulary Test (MWT-B).
Measured: Verbal intelligence (duration approx. 5 minutes) will be measured before one month of inpatient DBT/waiting time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Feb 2021
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oldenburg
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. René Hurlemann, Jella Voelter, M.Sc.
- Responsible party
- Principal investigator, Dirk Scheele, Ruhr University of Bochum
- Investigators
- Dirk Scheele, Prof., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770038
- Sponsor's protocol ID
- SANITY
- Acronym
- SANITY
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response
- ClinicalTrials.gov ID
- NCT04770038
- Acronym / sponsor ID
- SANITY / SANITY
- Conditions
- Borderline Personality Disorder (BPD)
- Keywords
- social integration, Borderline Personality Disorder, treatment response, psychiatric inpatient treatment, fMRI, negative social bias, social touch, interoception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of OldenburgUniversity, hospital or other
- Collaborators
- Prof. René Hurlemann, Jella Voelter, M.Sc.
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 25 Feb 2021 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Behavioral: Dialectical Behavior Therapy (DBT)56 BPD patients |
| Control Group | – | –31 Healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Dialectical Behavior Therapy (DBT)Evidence-based psychotherapy for the treatment of Borderline Personality Disorder | Behavioural | Patient Group |
Primary outcome
Social integration during inpatient treatment as measured by questionnaires and interviews
Time frame: Social integration (duration approx. 30-45 minutes) will be measured continuously during inpatient treatment (twice a week for four weeks).
Social integration will be assessed with questionnaires and interviews (e.g. the perceived social support questionnaire).
Changes in neural responses to interpersonal touch
Time frame: The fMRI task (duration approx. 15 minutes) will be performed before and after one month of inpatient DBT/waiting time.
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.
Changes in comfort ratings of interpersonal touch in the fMRI task
Time frame: The fMRI task (duration approx. 15 minutes) will be performed before and after one month of inpatient DBT/waiting time.
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.
Changes in neural responses in the Trust Game
Time frame: The fMRI task (duration approx. 6 minutes) will be performed before and after one month of inpatient DBT/waiting time.
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.
Changes in interpersonal trust
Time frame: The fMRI task (duration approx. 6 minutes) will be performed before and after one month of inpatient DBT /waiting time.
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.
Changes in neural responses during an interoception task
Time frame: The fMRI task (duration approx. 13 minutes) will be performed before and after one month of inpatient DBT/waiting time.
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.
Changes in intensity ratings of bodily awareness in the fMRI task
Time frame: The fMRI task (duration approx. 13 minutes) will be performed before and after one month of inpatient DBT/waiting time.
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.
Changes in interoceptive accuracy as measured by a heartbeat discrimination task
Time frame: Interoceptive accuracy (duration approx. 20 minutes) will be assessed before and after one month of inpatient DBT/waiting time.
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.
Changes in interoceptive sensibility as measured with a questionnaire
Time frame: Interoceptive sensibility (duration approx. 5 minutes) will be measured before and after one month of inpatient DBT/waiting time.
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.
Changes in psychophysiological measures during a positive social interaction
Time frame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
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.
Changes in hormone and enzyme salivary concentrations in response to a positive social interaction
Time frame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
Saliva samples will be collected before, immediately after, and 15 minutes after the social interaction task.
Changes in mood in response to a social interaction
Time frame: The positive social interaction (duration approx. 15 minutes) will be conducted before one month of inpatient DBT/waiting time
Mood state will be assessed with questionnaires (e.g. the Profile of Mood States (POMS)).
Changes in bodily maps of social touch
Time frame: The bodily maps (duration approx. 10-15 minutes) will be assessed before and after 4-weeks DBT treatment/waiting time.
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.
Changes in attitude towards social touch
Time frame: 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.
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.
Changes in negative social biases
Time frame: 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.
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.
Changes in symptom load
Time frame: 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.
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.
7 secondary outcomes
Changes in neural activity at resting state
Time frame: Resting State (duration approx. 10 minutes) will be performed before and after one month of inpatient DBT/waiting time.
Changes in vigilance
Time frame: Vigilance (duration approx. 5 minutes) will be measured one week before and after one month of inptatient DBT/waiting time.
Childhood maltreatment
Time frame: The CTQ (duration approx. 5 minutes) will be performed before one month of inpatient DBT/waiting time.
Changes in symptom load of possible comorbidities
Time frame: 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
Time frame: Personality traits (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT/waiting time.
Psychotherapy outcome as measured with a questionnaire
Time frame: Psychotherapy outcome (duration approx. 5 minutes) will be measured after one month of inpatient DBT.
Verbal intelligence
Time frame: Verbal intelligence (duration approx. 5 minutes) will be measured before one month of inpatient DBT/waiting time.
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 8 Mar 2023.
- Research group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Recruiting
Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
Borderline Personality Disorder (BPD), Dialectical Behavior Therapy
RecruitingObservational study
Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient
Borderline Personality Disorder
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.
Dirk Scheele, Prof. principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder (BPD), run by University of Oldenburg at 1 site in Germany.
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 4 inclusion and 5 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 8 Mar 2023. 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 Germany. 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?
Social integration during inpatient treatment as measured by questionnaires and interviews (time frame: Social integration (duration approx. 30-45 minutes) will be measured continuously during inpatient treatment (twice a week for four weeks).). The study lists 16 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 8 Mar 2023.