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

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345053
• Other study ID #: 203428
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Norwegian University of Science and Technology
• Contact: Johanna Vigfusdottir
• Phone: +4746746154
• Email: johannavigfusd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotion Regulation
• Post Traumatic Stress Disorder
• Self-harm
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders
• Suicide

Intervention

Behavioral:
• Narrative Exposure 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.

Locations

Country	Name	City	State
Norway	Molde Treatment Center, Møre and Romsdal Hospital Trust	Molde	Møre And Romsdal

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Møre og Romsdal Hospital Trust, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One time assessment 5 weeks after admission to treatment
Primary	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.	One time assessment 5 weeks after admission to treatment
Primary	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).	One time assessment 5 weeks after admission to treatment
Primary	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.	From treatment start to compleation up to 9 months.
Primary	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.	From treatment start to compleation up to 9 months.
Primary	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.	From treatment start to compleation up to 9 months.
Primary	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.	From treatment start to compleation up to 9 months.
Primary	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)	From treatment start to treatment compleation up to 9 months.
Secondary	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).	From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.
Secondary	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).	From 5 weeks after admission to treatment to 12-month follow upp after treatment completion. Up to 21 months.
Secondary	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.	From treatment completion to 3- and 12 month follow up - up to 12 months.
Secondary	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.	From treatment completion to 3- and 12 month follow up - up to 12 months.