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Post Traumatic Stress DisorderNCT06345053

Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder

A study testing Narrative Exposure Therapy in people with Post Traumatic Stress Disorder and Substance Use Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Narrative Exposure Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNorway
Study dates
1 May 2021to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria for the study:
  • Fit general inclusion criteria for the in-patient program.
  • Speak Scandinavian (Norwegian, Danish and/or Swedish).
  • Be willing to sign a consent.
  • Experience of an aversive event that fits criteria A for PTSD as defined by Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) (American Psychiatric Association [APA], 2013).
  • Experience symptoms of PTSD as defined by the DSM-V (APA, 2013), or subthreshold PTSD (Grubaugh et al., 2005), or experience clinically relevant symptoms as evaluated by a NET therapist.
Show all 9Show fewer
  • Subthreshold PTSD is defined as having experienced a traumatic event (Criteria A), meeting Criteria B (re-experiencing symptoms), Criteria E (one-month symptom duration), and Criteria F (significant distress or functioning impairment) and either Criteria C (avoidance or numbing symptoms) or Criteria D (hyper arousal symptoms).
  • Experience difficulties in emotion regulation evaluated by an assigned DBT therapist.
  • Manage to commit to participating in the DBT- skills training.

Who cannot join

  • General exclusion criteria for the study:
  • Have a clinically significant low cognitive- and/or linguistic functioning that hinders the patient in understanding and answering the questions on the self-rapport instruments.
  • Being actively psychotic.
  • Have a Body Mass Index (BMI) under 17.
  • Severe dissociation.
  • An ongoing traumatic contact with the perpetrator.

Trial locations and contacts

1 site in 1 country.

Johanna Vigfusdottir contact

+4746746154

johannavigfusd@gmail.com

Edvard Breivik contact

+4793032613

Norway1 site, 1 recruiting

  • Molde Treatment Center, Møre and Romsdal Hospital Trust

    Molde, Møre and Romsdal, 6410

    Edvard Breivik, +4793032613, edvard.breivik@helse-mr.no

    Johanna Vigfusdottir, +4746746154, johannavigfusd@gmail.com

    Recruiting

Other trials in Norway

About this study

Official title: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder; a Feasibility Study of a Combined Treatment for Difficulties in Emotion Regulation and PTSD

There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates.

This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population.

Being tested
Narrative Exposure Therapy
Keywords
Dialectical Behaviour Therapy, Narrative Exposure Therapy
Medical subject headings
Stress Disorders, Post-Traumatic, Substance-Related Disorders, Emotional Regulation, Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrative Exposure TherapyBehavioural

    Also called Dialectical Behaviour Therapy

    The intervention period will be from (May 2021- October 2024). All patients will participate in standard treatment at MBS. Dialectical Behaviour Therapy -Substance Use Disorder skills training (DBT-SUD skills) will be offered to all patients at MBS in the project period that experience difficulties in emotion regulation and manage to commit to participating in the DBT- skills training evaluated by their DBT therapist. Narrative Exposure Therapy (NET) will be offered to all patients with relevant traumatic experience and symptoms of PTSD depending on clinical evaluation.

Study groups in NCT06345053
Study groupRoleWhat they receive
Trauma fit inclusion / accept participation in DBT-SUD skills NETExperimentalAll patients with relevant will be offered to participate in DBT-SUD skills training and or NET.
Receives: Behavioral: Narrative Exposure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The intervention is relevant - prevalence of PTSD /SUP PTSD.

    The prevalence of PTSD/SUB-PTSD is measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) a 30-item structured interview used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week (Weathers et al., 2018). Frequency and intensity rating is summed to create an overall PTSD symptom severity score and is used to generate a categorical diagnosis (PTSD/Sub-PTSD vs non-PTSD). In this project, we will both use the categorical diagnosis to compare those with and without PTSD/Sub-PTSD, as using the overall PTSD symptom severity scores (Weathers et al., 2018).

    Measured: One time assessment 5 weeks after admission to treatment

  2. The intervention is relevant - prevalence of traumatic experiences.

    The prevalence of traumatic experiences also as offenders is measured with Stressful Life Events Screening Questionnaire-Revised (SLESQ) is self-report instrument designed to map and assess 15 potentially traumatic experiences (Goodman et al., 1998). The score is used to identify experiences of potential traumatic events. For this project, items asking about experiences where the participant caused potentially traumatic experiences to others are added. This is to identify violent offenders.

    Measured: One time assessment 5 weeks after admission to treatment

  3. The intervention is relevant - The severitiy of difficulties in emotion regulation.

    The severity of difficulties in emotion regulation will be measured with Difficulties in Emotion Regulation Scale (DERS) is a self-report instrument consisting of 36 items meant to measure difficulties in emotion regulation, higher scores ranging from 36- 144 indicate more significant difficulties in emotion regulation (Gratz \& Roemer, 2004). We will use the cut score of 97 to identify severe difficulties in emotion regulation (Bemmouna et. Al 2022; Neacsiu et. al., 2014).

    Measured: One time assessment 5 weeks after admission to treatment

  4. The intervention is feasible, accepted and safe - The dropout rate from treatment.

    The dropout rate from the standard treatment, DBT- SUD skills and NET. Dropout is registered, and dichotomous variables are created (yes/no). In case of dropout, time from admission to dropout is registered.

    Measured: From treatment start to compleation up to 9 months.

  5. The intervention is safe - Suicide behaviour while in treatment.

    Prevalance of suicide behavior before treatment and while in treatment is registrert with the Columbia-suicide severity rating scale (C-SSRS) a suicidal ideation and behaviour-rating interview created to evaluate suicide risk. The interview consists of 10 categories with binary responses (yes/no) to indicate a presence or absence of the behaviour. The outcome of the C-SSRS is a numerical score obtained from the categories (Posner et.al. 2011). The participants Answer the interview 5 weeks from treatment start and at treatment compleation.

    Measured: From treatment start to compleation up to 9 months.

  6. The intervention is safe - Self-harm behaviour while in treatment.

    Prevelance of Self-harm behaviour before tratment and while in treatment is registrert with The Deliberate Self-Harm Inventory (DSHI). DSHI is a 17 -item behaviourally based, self-report instrument to assess deliberate self-harm (Gratz, 2001). In this project we create a continuous variable on frequency of self-harm behaviour and a dichotomous variable on presence of self-harm (Yes/No). e of the C-SSRS is a numerical score obtained from the categories (Posner et.al. 2011). The participants answer the DSHI at 5 weeks from treatment start and at treatment compleation.

    Measured: From treatment start to compleation up to 9 months.

  7. The intervention is accepted - participation in DBT-SUD skills sessions.

    The percentage of DBT-SUD skills sessions participated in, as well as the percentage completion of homework.

    Measured: From treatment start to compleation up to 9 months.

  8. The intervention is feasible and accepted - Objective experience of treatment.

    A self-rapport questionnaire is designed to evaluate the experience of the treatment. Rating on a 5 Likert scale how different elements of the treatment are experienced on a 5-point scale. There are also open-ended questions about what in the treatment is most useful and what was the least helpful (see attachment 1-2 in protocol)

    Measured: From treatment start to treatment compleation up to 9 months.

Secondary outcomes (4)

  1. The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up.

    Evaluate the change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, measured with PTSD Checklist for DSM-5 (PCL-5), a self-report instrument developed for quick screening of PTSD symptoms. Sum scores range from 0-80, with a score over 33 indicating the presence of PTSD (Weathers et al., 2013).

    Measured: From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.

  2. The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up.

    difficulties in emotion regulation measured with Difficulties in Emotion Regulation Scale (DERS) a self-report instrument consisting of 36 items meant to measure difficulties in emotion regulation, higher scores ranging from 36- 144 indicate more significant difficulties in emotion regulation (Gratz \& Roemer, 2004). We will use the cut score of 97 to identify severe difficulties in emotion regulation (Bemmouna et. Al 2022; Neacsiu et. al., 2014).

    Measured: From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.

  3. The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up.

    Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening instrument to assess severity of alcohol consumption, drinking behaviours, and alcohol-related problems. Audit scores range from 0-40 with higher scores indicating greater problems related to alcohol consumptions (Aasland, Amundsen, Bovi, Fauske \& Mørland, 1990). In this project, the consumption score (question 1) with cut-of score 3 and over (drinking alcohol 2 -3 times a week) is coded into a dichotomous variable of current alcohol use (yes/no) and sum score used to assess severity of alcohol related problems. At 3 months or 12 months evaluation a cut-off score 3 and over on question 1 is registered as relapse.

    Measured: From treatment completion to 3- and 12 month follow up - up to 12 months.

  4. The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up.

    Realalse to substance abuse is evaluated with the Drug Use Disorder Identification Test (DUDIT), a nine item self-report instrument developed for identification of individuals with drug-related problems. DUDIT scores range from 0-44 with higher scores indicating more drug use and drug related problems (Berman, Palmstierna, Källmén, \& Bergman, 2007). In this project, the substance use frequency score (question 1) is used to identify current substance use with cut-off score score 3 and over (using substances 2-3 times a week) will be coded into a dichotomous variable (yes/no). The sum score is used to assess severity of substance related problems. At 3 months or 12 months evaluation a cut-off score 3 and over on question 1 is registered as relapse.

    Measured: From treatment completion to 3- and 12 month follow up - up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start1 May 2021
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
This is a repeated measures follow-up feasibility study without control group.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345053
Sponsor's protocol ID
203428
Status last verified
Apr 2024
First submitted
6 Mar 2024
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aasland OG, Amundsen A, Bovim G, Fauske S, Morland J. [Identification of patients at risk of alcohol related damage]. Tidsskr Nor Laegeforen. 1990 May 10;110(12):1523-7. Norwegian.

    PubMed 2339403

  • Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.

    PubMed 24413388

  • Bemmouna D, Coutelle R, Weibel S, Weiner L. Feasibility, Acceptability and Preliminary Efficacy of Dialectical Behavior Therapy for Autistic Adults without Intellectual Disability: A Mixed Methods Study. J Autism Dev Disord. 2022 Oct;52(10):4337-4354. doi: 10.1007/s10803-021-05317-w. Epub 2021 Oct 9.

    PubMed 34626285

  • Berman AH, Palmstierna T, Kallmen H, Bergman H. The self-report Drug Use Disorders Identification Test: Extended (DUDIT-E): reliability, validity, and motivational index. J Subst Abuse Treat. 2007 Jun;32(4):357-69. doi: 10.1016/j.jsat.2006.10.001. Epub 2006 Dec 11.

    PubMed 17481459

  • Brady, K. T., Back, S. E., & Coffey, S. F. (2004). Substance abuse and posttraumatic stress disorder. Current directions in psychological science, 13(5), 206-209.

  • Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental disorders: a meta-review. World Psychiatry. 2014 Jun;13(2):153-60. doi: 10.1002/wps.20128.

    PubMed 24890068

  • Elbert, T., Hermenau, K., Hecker, T., Weierstall, R., & Schauer, M. (2012). FORNET: Behandlung von traumatisierten und nicht-traumatisierten Gewalttätern mittels Narrativer Expositionstherapie.

  • Elbert, T., Schauer, M., & Neuner, F. (2015). Narrative exposure therapy (NET): Reorganizing memories of traumatic stress, fear, and violence. In Evidence based treatments for trauma-related psychological disorders (pp. 229-253). Springer, Cham.

  • Espie CA, Farias Machado P, Carl JR, Kyle SD, Cape J, Siriwardena AN, Luik AI. The Sleep Condition Indicator: reference values derived from a sample of 200 000 adults. J Sleep Res. 2018 Jun;27(3):e12643. doi: 10.1111/jsr.12643. Epub 2017 Nov 29.

    PubMed 29193493

  • Goodman LA, Corcoran C, Turner K, Yuan N, Green BL. Assessing traumatic event exposure: general issues and preliminary findings for the Stressful Life Events Screening Questionnaire. J Trauma Stress. 1998 Jul;11(3):521-42. doi: 10.1023/A:1024456713321.

    PubMed 9690191

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Gratz, K. L. (2001). Measurement of deliberate self-harm: Preliminary data on the Deliberate Self-Harm Inventory. Journal of psychopathology and behavioral assessment, 23(4), 253-263.

  • Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.

  • Grubaugh AL, Magruder KM, Waldrop AE, Elhai JD, Knapp RG, Frueh BC. Subthreshold PTSD in primary care: prevalence, psychiatric disorders, healthcare use, and functional status. J Nerv Ment Dis. 2005 Oct;193(10):658-64. doi: 10.1097/01.nmd.0000180740.02644.ab.

    PubMed 16208161

  • Harder DW, Cutler L, Rockart L. Assessment of shame and guilt and their relationships to psychopathology. J Pers Assess. 1992 Dec;59(3):584-604. doi: 10.1207/s15327752jpa5903_12.

    PubMed 1487811

Questions about this trial

What is this clinical trial studying?

A study testing Narrative Exposure Therapy in people with Post Traumatic Stress Disorder and Substance Use Disorders, run by Norwegian University of Science and Technology 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johanna Vigfusdottir (+4746746154, johannavigfusd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The intervention is relevant - prevalence of PTSD /SUP PTSD. (time frame: One time assessment 5 weeks after admission to treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345053, which also lists 48 linked publications.

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 3 Apr 2024.

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