Self HarmNCT03846375
Emotional Dysregulation in Para-suicidal Behavior
A study testing Psychotherapy and Pre-intervention testing in people with Self Harm and Suicide, Attempted, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Harm, Suicide, Attempted, Emotional Instability
- What is being tested?
- Psychotherapy and Pre-intervention testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2019to 2 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with non-suicidal self-injury and/or suicidal ideation that undergo standard clinical outpatient DBT treatment will be recruited.
Who cannot join
- Lack of informed consent
- Lack of informed consent
- former or current neurological conditions
- severe psychiatric illness
- cardiac conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lin Sørensen, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital, Bjørgvin DPS
Bergen, 5009
Berge Osnes, PhD, +4792445081, berge.osnes@uib.no
About this study
Official title: Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach
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.
Read the 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.
- Being tested
- Psychotherapy, Pre-intervention testing
- Keywords
- Emotional Dysregulation, Emotional regulation, Dialectical Behavioral Therapy, para-suicidal behavior
- Medical subject headings
- Self-Injurious Behavior, Suicide, Attempted, Borderline Personality Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
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 testingOther
Pre-intervention testing for baseline measures.
| Study group | Role | What they receive |
|---|---|---|
| Participants in DBT | Experimental | Psychotherapy: The participants will be given standard DBT treatment. Receives: Behavioral: Psychotherapy; Other: Pre-intervention testing |
| Control Group | Other | Control Group at preintervention. Receives: Other: Pre-intervention testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of Suicidal thoughts.
Intensity of suicidal thoughts on a likert scale from 0 - 5 the last week.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
Change in impulsivity through The Barratt Impulsiveness Scale.
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 .
Measured: Time points will be baseline, week 16, week 32 and at completion of the DBT program, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start15 Jan 2019
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Berge Osnes, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846375
- Sponsor's protocol ID
- 2018/1554/REK-C
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Dysregulation in Para-suicidal Behavior: Effects of Dialectical Behavioral Therapy on Emotional Processing, a Triangulation Approach
- ClinicalTrials.gov ID
- NCT03846375
- Acronym / sponsor ID
- 2018/1554/REK-C
- Keywords
- Emotional Dysregulation, Emotional regulation, Dialectical Behavioral Therapy, para-suicidal behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants in DBT | Experimental | Behavioral: Psychotherapy, Other: Pre-intervention testingPsychotherapy: The participants will be given standard DBT treatment. |
| Control Group | Other | Other: Pre-intervention testingControl Group at preintervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-suicidal self-injury and/or suicidal ideation that undergo standard clinical outpatient DBT treatment will be recruited.
Key exclusion criteria (5 listed)
- Lack of informed consent
- Lack of informed consent
- former or current neurological conditions
- severe psychiatric illness
- cardiac conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyDBT 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. | Behavioural | Participants in DBT |
| Pre-intervention testingPre-intervention testing for baseline measures. | Other | Control Group, Participants in DBT |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Sørensen, PhD contact
Berge Osnes, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy and Pre-intervention testing in people with Self Harm and Suicide, Attempted, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berge Osnes, PhD (+4792445081, berge.osnes@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.