Clinical trial NCT06345053: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Substance Use Disorders
Emotion Regulation
Suicide
Self-harm
Keywords: Dialectical Behaviour Therapy
Narrative Exposure Therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Møre og Romsdal Hospital Trust
name: Oslo University Hospital
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a repeated measures follow-up feasibility study without control group.
Primary purpose: TREATMENT

Brief 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. 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.


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.

Primary outcomes:
measure: The intervention is relevant - prevalence of PTSD /SUP PTSD.
timeFrame: One time assessment 5 weeks after admission to treatment
measure: The intervention is relevant - prevalence of traumatic experiences.
timeFrame: One time assessment 5 weeks after admission to treatment
measure: The intervention is relevant - The severitiy of difficulties in emotion regulation.
timeFrame: One time assessment 5 weeks after admission to treatment
measure: The intervention is feasible, accepted and safe - The dropout rate from treatment.
timeFrame: From treatment start to compleation up to 9 months.
measure: The intervention is safe - Suicide behaviour while in treatment.
timeFrame: From treatment start to compleation up to 9 months.
measure: The intervention is safe - Self-harm behaviour while in treatment.
timeFrame: From treatment start to compleation up to 9 months.
measure: The intervention is accepted - participation in DBT-SUD skills sessions.
timeFrame: From treatment start to compleation up to 9 months.
measure: The intervention is feasible and accepted - Objective experience of treatment.
timeFrame: From treatment start to treatment compleation up to 9 months.
Secondary outcomes:
measure: The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up.
timeFrame: From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.
measure: The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up.
timeFrame: From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.
measure: The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up.
timeFrame: From treatment completion to 3- and 12 month follow up - up to 12 months.
measure: The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up.
timeFrame: From treatment completion to 3- and 12 month follow up - up to 12 months.
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Molde Treatment Center, Møre and Romsdal Hospital Trust
state: Møre And Romsdal
Study officials:
affiliation: Norwegian University of Science and Technology
name: Egil Jonsbu
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Johanna Vigfusdottir
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Edvard Breivik
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Erlend Mork
role: STUDY_CHAIR
affiliation: National Competence Center for Co-Occurring Addictive and Psychiatric Disorders
name: Lars Lien
role: STUDY_CHAIR
affiliation: Regional Center for Violence and Traumatic Stress and St. Olavs Hospital
name: Håkon Stenmark
role: STUDY_CHAIR
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