Protocol for a feasibility study, without control group, of a combined treatment for PTSD and difficulties in emotion regulation for patients with substance use disorder.
Johanna Vigfusdottir, Edvard Breivik, Erlend Mork, Lars Lien, Håkon Stenmark, Egil Jonsbu
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引用次数: 0
Abstract
Background: There are high rates of co-occurring post-traumatic stress disorder (PTSD) among patients in treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, which is rarely the case. The reluctance to offer trauma-focused treatment is partially due to fear of increased risk of dropout. PTSD is related to emotion dysregulation and elevated psychological burden, higher dropout rates and increased risk of relapse. In this project, we plan to assess if it is relevant, feasible, acceptable and safe to add a combination of narrative exposure therapy (NET) and dialectical behaviour therapy for substance use disorder skills training (DBT-SUD Skills) to standard inpatient SUD treatment.
Methods: We will recruit patients from a long-term inpatient SUD treatment centre on the west coast of Norway (N approx. = 90). We will assess relevance based on the prevalence of PTSD/Subthreshold-PTSD and traumatic experiences, suicidal behaviour, self-harm, and the severity of difficulties in emotion regulation. We will assess acceptability with treatment participation among patients and the subjective experience of the treatment. We will measure safety with the rate of dropout and destructive behaviour in the treatment period.
Discussion: It is important to develop and evaluate treatment options for this vulnerable patient population, often excluded from clinical research. Strengths include a naturalistic setting and historical data for comparison. Limitations are the absence of a control group and inability to isolate component effects. The results can be used to develop a treatment protocol for combining NET and DBT-skills training to in patient SUD treatment for further development and testing in a multicentre Protocol following SPIRIT 2025 guidelines.
Trial registration: This trial was retrospectively registered at ClinicalTrials.gov on 3 April 2024 (#203,428).
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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