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Search / Trial NCT06345053

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

Launched by NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · Apr 2, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Dialectical Behaviour Therapy Narrative Exposure Therapy

ClinConnect Summary

This clinical trial is studying the connection between Post Traumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) in patients receiving treatment. Many people with SUD also have PTSD, but often they don’t receive the help they need for both conditions at the same time. The researchers want to see if combining two types of therapy—Dialectical Behavior Therapy (DBT), which helps with managing emotions, and Narrative Exposure Therapy (NET), which focuses on healing from trauma—can improve treatment outcomes for patients. They will look at things like the severity of PTSD symptoms, the rate of self-harm, and the likelihood of patients dropping out of treatment or relapsing after leaving the program.

To be eligible for the study, participants should be between 18 and 74 years old, speak a Scandinavian language (like Norwegian, Danish, or Swedish), and be willing to participate. They should also have experienced a traumatic event that meets certain criteria and have difficulty regulating their emotions. During the trial, participants will receive standard treatment for SUD along with the new therapies, and the researchers will check in with them after treatment and again at 3 and 12 months to see how they are doing. This study aims to help improve treatment options for those dealing with both PTSD and substance use issues.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * General inclusion criteria for the study:
  • 1. Fit general inclusion criteria for the in-patient program.
  • 2. Speak Scandinavian (Norwegian, Danish and/or Swedish).
  • 3. Be willing to sign a consent.
  • Inclusion criteria for NET intervention:
  • 1. 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).
  • 2. 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.
  • 1. 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).
  • Inclusion criteria for DBT intervention:
  • 1. Experience difficulties in emotion regulation evaluated by an assigned DBT therapist.
  • 2. Manage to commit to participating in the DBT- skills training.
  • Exclusion Criteria:
  • * General exclusion criteria for the study:
  • 1. 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.
  • Exclusion criteria for NET and/or DBT-SUD skills
  • 1. Being actively psychotic.
  • 2. Have a Body Mass Index (BMI) under 17.
  • 3. Severe dissociation.
  • 4. An ongoing traumatic contact with the perpetrator.

About Norwegian University Of Science And Technology

The Norwegian University of Science and Technology (NTNU) is a leading research institution dedicated to advancing knowledge and innovation in various scientific fields. Renowned for its commitment to interdisciplinary collaboration, NTNU plays a pivotal role in addressing global health challenges through rigorous clinical trials and research initiatives. The university's emphasis on cutting-edge technology and its strong partnerships with healthcare sectors position it as a key player in translational research, ensuring that findings contribute effectively to improving public health and patient care. With a focus on ethical standards and scientific integrity, NTNU is dedicated to fostering advancements that enhance the quality of life and health outcomes for diverse populations.

Locations

Molde, Møre And Romsdal, Norway

Molde, Norway

Patients applied

0 patients applied

Trial Officials

Egil Jonsbu

Study Director

Norwegian University of Science and Technology

Johanna Vigfusdottir

Principal Investigator

Norwegian University of Science and Technology

Edvard Breivik

Principal Investigator

Norwegian University of Science and Technology

Erlend Mork

Study Chair

Oslo University Hospital

Lars Lien

Study Chair

National Competence Center for Co-Occurring Addictive and Psychiatric Disorders

Håkon Stenmark

Study Chair

Regional Center for Violence and Traumatic Stress and St. Olavs Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported