Emotional Dysregulation in Para-suicidal Behavior

NCT03846375 | Recruiting

• 1 other identifier: 2018/1554/REK-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Harm; Suicide, Attempted; Emotional Instability; Borderline Personality Disorder

Keywords

Emotional Dysregulation; Emotional regulation; Dialectical Behavioral Therapy; para-suicidal behavior

Outcome Measures

Primary Outcomes (6)

• Change in intensity of Suicidal thoughts.

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

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

• Change in frequency of suicidal thoughts.

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

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

• Change in frequency of non-suicidal self-injury.

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

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

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

• Change in Heart rate variability .

  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.

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

• Change in self reported emotion regulation ability through Difficulties in Emotion Regulation Scale.

  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.

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

Secondary Outcomes (6)

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

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

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

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

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

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

• Change in anxiety symptoms through the Beck Anxiety Inventory.

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

• Change in depressive symptoms through the Beck Depression Inventory.

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

Other Outcomes (3)

• International Neuropsychiatric Interview.

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

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

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

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

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

Study Arms (2)

Participants in DBT

EXPERIMENTAL

Psychotherapy: The participants will be given standard DBT treatment.

Behavioral: Psychotherapy; Other: Pre-intervention testing

Control Group

OTHER

Control Group at preintervention.

Other: Pre-intervention testing

Interventions

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.

Participants in DBT

Pre-intervention testing OTHER

Pre-intervention testing for baseline measures.

Control Group; Participants in DBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital, Bjørgvin DPS

Bergen, 5009, Norway

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide, Attempted; Borderline Personality Disorder; Emotional Regulation

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Personality Disorders; Mental Disorders; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Berge Osnes, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berge Osnes, PhD

CONTACT

+4792445081; berge.osnes@uib.no

Lin Sørensen, PhD

CONTACT

lin.sorensen@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Control group only at pre-intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: February 19, 2019
• Study Start: January 15, 2019
• Primary Completion: January 2, 2025
• Study Completion (Estimated): January 2, 2028
• Last Updated: August 28, 2019

Record last verified: 2018-11

Locations

NO (1)