Social Integration During Psychiatric Inpatient Therapy as Predictor of Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Changes in interoceptive sensibility as measured with a questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in interoceptive sensibility as measured with a questionnaire
时间窗: 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 hormone and enzyme salivary concentrations in response to a positive social interaction
时间窗: 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.
Social integration during inpatient treatment as measured by questionnaires and interviews
时间窗: 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
时间窗: 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
时间窗: 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 psychophysiological measures during a positive social interaction
时间窗: 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 neural responses in the Trust Game
时间窗: 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 interoceptive accuracy as measured by a heartbeat discrimination task
时间窗: 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 mood in response to a social interaction
时间窗: 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 symptom load
时间窗: 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.
Changes in interpersonal trust
时间窗: 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
时间窗: 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
时间窗: 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 bodily maps of social touch
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Psychotherapy outcome as measured with a questionnaire(Psychotherapy outcome (duration approx. 5 minutes) will be measured after one month of inpatient DBT.)
- Childhood maltreatment(The CTQ (duration approx. 5 minutes) will be performed before 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.)
- 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.)
- Verbal intelligence(Verbal intelligence (duration approx. 5 minutes) will be measured before one month of inpatient DBT/waiting time.)
- Changes in personality traits(Personality traits (duration approx. 10 minutes) will be measured before and after one month of inpatient DBT/waiting time.)
研究者
Dirk Scheele
Prof.
Ruhr University of Bochum