Emotional Dysregulation in Para-suicidal Behavior

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Lack of informed consent

Lack of informed consent

former or current neurological conditions

severe psychiatric illness

Trial design

Design model

Single group

Treatments tested in this trial

  • Psychotherapy

    Behavioral

    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.

  • Pre-intervention testing

    Other intervention

    Pre-intervention testing for baseline measures.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Participants in DBTExperimental treatment 2 interventions
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in intensity of Suicidal thoughts.

Intensity of suicidal thoughts on a likert scale from 0 - 5 the last week.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
2

Change in frequency of suicidal thoughts.

Frequency of suicidal thoughts, that is the number of suicidal thoughts the last week.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
3

Change in frequency of non-suicidal self-injury.

The frequency of non-suicidal self-injury the last week.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
4

Change in the intensity of impulse to non-suicidal self-injury.

The intensity in the impulse to non-suicidal self-injury on a likert scale from 0 - 5, the last week.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

Secondary outcomes

1

Change in self reported ability to be mindful through the Five Facet Mindfulness Questionnaire.

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).

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
2

Change in self reported self-compassion through the Self-compassion Scale.

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.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
3

Change in ability to experience and verbalise emotions through Toronto Alexithymia Scale 20.

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.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
4

Change in anxiety symptoms through the Beck Anxiety Inventory.

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.

Time frame
Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.

Other outcomes

1

International Neuropsychiatric Interview.

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).

Time frame
Time points will be baseline and at completion of the DBT program, an average of 1 year.
2

Change in the presence of personality disorders through the Structured Clinical Interview for DSM-IV Axis II.

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.

Time frame
Time points will be baseline and at completion of the DBT program, an average of 1 year.
3

Change in every day functioning through the Global Assessment of Functioning.

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.

Time frame
Time points will be baseline and at completion of the DBT program, an average of 1 year.

Sponsors and contacts

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Haukeland University Hospital

Lead sponsor

University of Bergen

Collaborator