protocolSection identificationModule nctId: NCT06345053, orgStudyIdInfo id: 203428, briefTitle: Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Norwegian University of Science and Technology, class: OTHER, collaborators name: Møre og Romsdal Hospital Trust, collaborators name: Oslo University Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Post Traumatic Stress Disorder, conditions: Substance Use Disorders, conditions: Emotion Regulation, conditions: Suicide, conditions: Self-harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a repeated measures follow-up feasibility study without control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Narrative Exposure Therapy, outcomesModule primaryOutcomes measure: The intervention is relevant - prevalence of PTSD /SUP PTSD., primaryOutcomes measure: The intervention is relevant - prevalence of traumatic experiences., primaryOutcomes measure: The intervention is relevant - The severitiy of difficulties in emotion regulation., primaryOutcomes measure: The intervention is feasible, accepted and safe - The dropout rate from treatment., primaryOutcomes measure: The intervention is safe - Suicide behaviour while in treatment., primaryOutcomes measure: The intervention is safe - Self-harm behaviour while in treatment., primaryOutcomes measure: The intervention is accepted - participation in DBT-SUD skills sessions., primaryOutcomes measure: The intervention is feasible and accepted - Objective experience of treatment., secondaryOutcomes measure: The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up., secondaryOutcomes measure: The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up., secondaryOutcomes measure: The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up., secondaryOutcomes measure: The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Molde Treatment Center, Møre and Romsdal Hospital Trust, status: RECRUITING, city: Molde, state: Møre And Romsdal, zip: 6410, country: Norway, contacts name: Edvard Breivik, role: CONTACT, phone: +4793032613, email: edvard.breivik@helse-mr.no, contacts name: Johanna Vigfusdottir, role: CONTACT, phone: +4746746154, email: johannavigfusd@gmail.com, geoPoint lat: 62.73752, lon: 7.15912, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-15, uploadDate: 2024-03-18T06:41, filename: Prot_SAP_000.pdf, size: 766255, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-25, uploadDate: 2024-03-25T10:01, filename: ICF_001.pdf, size: 621574, hasResults: False