Clinical trial NCT03846375: Emotional Dysregulation in Para-suicidal Behavior
Official title: Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self Harm
Suicide, Attempted
Emotional Instability
Borderline Personality Disorder
Keywords: Emotional Dysregulation
Emotional regulation
Dialectical Behavioral Therapy
para-suicidal behavior
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2019-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Naturalistic cohort pre-post study. However, we also include a matched control sample of healthy controls to complete the battery of measurements at pre-intervention assessments.
Primary purpose: TREATMENT

Brief summary: This is a naturalistic cohort pre-post study investigating aspects of emotional processing and how possible changes in emotional processing is related to the successful treatment of non-suicidal self-injury and suicidal ideation in a program of Dialectical Behavior Therapy. In addition we wish to identify to what extent the intensity and frequency of non-suicidal self-injury and suicidal ideation is related to difficulty in emotion regulation, as indicated by self-report measures and psychophysiological measures.

Detailed description: This naturalistic pre-port study tests if Dialectical Behavior Therapy (DBT) - an established therapy addressing emotion regulation and reduction of non-suicidal self-injury and suicidal ideation - result in increased emotion regulation capacity, indicated by lowered heart rate variability (HRV) and self-report measures. The study will also test the impact of DBT on lowered non-suicidal self-injury and suicidal ideation. Standard Clinical symptom scales will be included in order to control for anxiety, depression, as well as a measure of impulsivity, which is common co-morbidities.

Since DBT was developed in the 80ies, DBT has gathered increased empirical support as a treatment that reduce suicidality, para-suicidal behavior, experienced and expressed anger, and increased social skills. In DBT, emotional dysregulation is assumed to arise from a combination of biological vulnerability and living in an invalidating environment.

Self-harm and chronic suicidality is considered to be an emotion regulation strategy. In DBT, the ability to regulate emotions adaptively requires a set of skills; the ability to experience emotions, the ability to label emotions, and the ability to modulate stimuli that serve to reactivate negative or positive emotions. In the absence of these skills, or instances where the individual is hindered from applying them, more maladaptive behavior is learned and applied. Individuals that engage in non-suicidal self-injury often report greater emotion dysregulation than those without an non-suicidal self-injury history. Such behavior can e.g. be self-inflicted harm, cutting, burning, or hitting , and/or suicidal ideation. Non-suicidal self-injury is viewed as a learned emotion regulation strategy; because such behavior instantly can decrease the experience of negative affect. Therapies that focus on increasing adaptive emotion regulations skills have demonstrated reduced non-suicidal self-injury and suicidal ideation.

The physiological manifestations of emotions rely on an activation of the Autonomic Nervous System. The individual experience of emotions is reciprocally related to the continuously changing levels of physiological arousal. The functioning of this system is in turn related to adapting to environmental demands. A well established measure of Autonomic Nervous activity is variation in inter-beat-intervals due to respiratory influence on heart rate, i.e. respiratory sinus arrhythmia, which is predominately a parasympathetic related innervation of the heart. Hence, HRV is considered a psychophysiological index of emotion regulation abilities. HRV is considered an index of the nervous system's ability to flexibly adapt to changing environmental demands and is considered a biological index of emotion regulation.

We include a matched control sample of healthy controls to complete the battery of measurements at baseline assessment of emotion regulation functions (pre-intervention assessments). This will give the opportunity to characterize the group of patients with non-suicidal self-injury and suicidal ideation included in the current planned study in relation to previous research findings of the same functions in samples of patients with non-suicidal self-injury and suicidal ideation. The combination of clinical, cognitive and psychophysiological measures is a unique feature of this study, and will provide new information regarding the mechanisms underpinning clinical change following DBT, and possibly validate heart rate variability as a possible psychophysiological outcome measure for studies on treatment for non-suicidal self-injury and suicidal ideation.

Statistical analyses Multilevel between-group analyses will be conducted to test for the between-group effects on the measures at baseline. Furthermore, a multiple regression analyses, so that dimensional variables can be included as independent variables in the model, for the pre and post measures. Regression analyses also allow for adjusting for the effects of possible confounders on the outcome measures, such as age, sex, and intensity of depressive symptoms. Furthermore, bootstrapping analysis will be conducted to examine moderator and mediator effects on the outcome measures. Interpretation of the strength of experimental effects will be guided by the use of effect size statistics. Baseline measures of demographics, life experiences, and symptoms may also be used to predict outcomes or as covariates in our analyses.

Eligibility criteria: Inclusion Criteria Patients:

* Patients with non-suicidal self-injury and/or suicidal ideation that undergo standard clinical outpatient DBT treatment will be recruited.

Exclusion Criteria Patients:

* Lack of informed consent

Exclusion Criteria Healthy Controls:

* Lack of informed consent
* former or current neurological conditions
* severe psychiatric illness
* cardiac conditions.

Primary outcomes:
measure: Change in intensity of Suicidal thoughts.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in frequency of suicidal thoughts.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in frequency of non-suicidal self-injury.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in the intensity of impulse to non-suicidal self-injury.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in Heart rate variability .
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in self reported emotion regulation ability through Difficulties in Emotion Regulation Scale.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
Secondary outcomes:
measure: Change in self reported ability to be mindful through the Five Facet Mindfulness Questionnaire.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in self reported self-compassion through the Self-compassion Scale.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in ability to experience and verbalise emotions through Toronto Alexithymia Scale 20.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in anxiety symptoms through the Beck Anxiety Inventory.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in depressive symptoms through the Beck Depression Inventory.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
measure: Change in impulsivity through The Barratt Impulsiveness Scale.
timeFrame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
Other outcomes:
measure: International Neuropsychiatric Interview.
timeFrame: Time points will be baseline and at completion of the DBT program, an average of 1 year.
measure: Change in the presence of personality disorders through the Structured Clinical Interview for DSM-IV Axis II.
timeFrame: Time points will be baseline and at completion of the DBT program, an average of 1 year.
measure: Change in every day functioning through the Global Assessment of Functioning.
timeFrame: Time points will be baseline and at completion of the DBT program, an average of 1 year.
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Bjørgvin DPS
Study officials:
affiliation: Haukeland University Hospital
name: Berge Osnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: