RecruitingNot Applicable

Emotional Dysregulation in Para-suicidal Behavior

Norway60 participantsStarted 2019-01-15

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

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.

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.

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.

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.

Trial details

NCT IDNCT03846375

SponsorHaukeland University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-02

Contact for this trial

Berge Osnes, PhD

+4792445081 berge.osnes@uib.no

View on ClinicalTrials.gov More Self Harm trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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.

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.

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.

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.

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.