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Emotional Dysregulation in Para-suicidal Behavior

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ClinicalTrials.gov Identifier: NCT03846375
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Self Harm Suicide, Attempted Emotional Instability Borderline Personality Disorder Behavioral: Psychotherapy Other: Pre-intervention testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: Control group only at pre-intervention.
Primary Purpose: Treatment
Official Title: Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach
Estimated Study Start Date : February 22, 2019
Estimated Primary Completion Date : January 2, 2025
Estimated Study Completion Date : January 2, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

Arm Intervention/treatment
Experimental: Participants in DBT
Psychotherapy: The participants will be given standard DBT treatment.
Behavioral: Psychotherapy
DBT is a well-established treatment for recurrent self-harm and suicidal thoughts. The program is principle-based, but the skills training follow a manualized curriculum.

Other: Pre-intervention testing
Pre-intervention testing for baseline measures.

Control Group
Control Group at preintervention.
Other: Pre-intervention testing
Pre-intervention testing for baseline measures.




Primary Outcome Measures :
  1. Change in intensity of Suicidal thoughts. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    Intensity of suicidal thoughts on a likert scale from 0 - 5 the last week.

  2. Change in frequency of suicidal thoughts. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    Frequency of suicidal thoughts, that is the number of suicidal thoughts the last week.

  3. Change in frequency of non-suicidal self-injury. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The frequency of non-suicidal self-injury the last week.

  4. Change in the intensity of impulse to non-suicidal self-injury. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The intensity in the impulse to non-suicidal self-injury on a likert scale from 0 - 5, the last week.

  5. Change in Heart rate variability . [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    Heart rate variability 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.

  6. Change in self reported emotion regulation ability through Difficulties in Emotion Regulation Scale. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    It is a 36 item questionnaire designed for measuring six facets of difficulties in emotion regulation. The response is give in the from of a rating of 5 point likert scale from 1 ("almost never" to 5 ("almost always). Total score range: 36- 180. It includes the following sub-scales: 1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity.


Secondary Outcome Measures :
  1. Change in self reported ability to be mindful through the Five Facet Mindfulness Questionnaire. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The Five Facet Mindfulness Questionnaire is a 39-item self-report questionnaire that assesses various components of mindfulness. Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). The higher score represents a more mindful attitude in daily life.The total score is a aggregate of the following sub-scales: (1) "observe" (the ability to ve aware of the surroundings and inner experiences, (2) describe (the ability to describe inner experiences, (3) act aware ( being aware and present, (4) non‐judge (ability to experience with acceptance, and (5) non‐react (being non-reactive excessively to inner experience).

  2. Change in self reported self-compassion through the Self-compassion Scale. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]

    The Self-compassion Scale questionnaire consists of 26 items. Items are rated on a five-point Likert-type scale from 1 ("almost never") to 5 ("almost always").

    Highest possible score is 130. High score indicate ability to be self-compassionate.


  3. Change in ability to experience and verbalise emotions through Toronto Alexithymia Scale 20. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The Toronto Alexithymia Scale 20 is a 20-item self-report questionnaire consisting of three sub-scales; 1) Difficulty Identifying feelings, 2) Difficulty Describing Feelings, and 3) Externally-oriented Thinking. The full scale range is 20-100, higher scores indicate higher problems in experiencing and verbalizing emotions, i.g. alexithymia. Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.

  4. Change in anxiety symptoms through the Beck Anxiety Inventory. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The Beck Anxiety Inventory is a 21-item self-report inventory that measures level of anxiety during the past week. Answer being scored on a scale value of 0 (not at all) to 3 (severely). Above 30 indicate severe anxiety, below 21 indication of low og no anxiety.

  5. Change in depressive symptoms through the Beck Depression Inventory. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    Beck Depression Inventory is a 21-item self-report inventory that measures level of depression and is a widely applied measure of depression. Highest possible score is 64. Above 25 indicates severe depressive symptoms, below 9 no depressive symptoms.

  6. Change in impulsivity through The Barratt Impulsiveness Scale. [ Time Frame: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year. ]
    The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness is composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .


Other Outcome Measures:
  1. International Neuropsychiatric Interview. [ Time Frame: Time points will be baseline and at completion of the DBT program, an average of 1 year. ]
    The International Neuropsychiatric Interview is a semi-structured diagnostic interview is a structured interview to evaluate the presence of current psychiatric disorders in children, based on 10th revision of the International Statistical Classification of Diseases and Related Health Problems and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The results will be combined to one binary total score 0 (no disorder) and 1 (current disorder).

  2. Change in the presence of personality disorders through the Structured Clinical Interview for DSM-IV Axis II. [ Time Frame: Time points will be baseline and at completion of the DBT program, an average of 1 year. ]
    A semi-structured diagnostic interview used to assess personality disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The interview covers all ten DSM-IV personality disorders (antisocial, avoidant, borderline, dependent, histrionic, narcissistic, obsessive-compulsive, paranoid, schizoid and schizotypal), personality disorder not otherwise specified, and is used to make personality disorder diagnoses either dimensionally or categorically (present-absent). The instrument will applied dimensionally with scores ranging from 0 to 9. Higher score indicate the presence of personality traits.

  3. Change in every day functioning through the Global Assessment of Functioning. [ Time Frame: Time points will be baseline and at completion of the DBT program, an average of 1 year. ]
    Global Assessment of Functioning is a numeric scale used to rate subjectively the social, occupational, and psychological functioning of an individual his or her day-to-day life on a scale of 0 to 100. High score indicate high functioning.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846375


Contacts
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Contact: Berge Osnes, PhD +4792445081 berge.osnes@uib.no
Contact: Lin Sørensen, PhD lin.sorensen@uib.no

Locations
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Norway
Haukeland University Hospital, Bjørgvin DPS Recruiting
Bergen, Norway, 5009
Contact: Berge Osnes, PhD    +4792445081    berge.osnes@uib.no   
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Berge Osnes, PhD Haukeland University Hospital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03846375     History of Changes
Other Study ID Numbers: 2018/1554/REK-C
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Emotional Dysregulation
Emotional regulation
Dialectical Behavioral Therapy
para-suicidal behavior

Additional relevant MeSH terms:
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Suicide
Personality Disorders
Borderline Personality Disorder
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms
Mental Disorders