{"doi":"10.1186/s12888-024-06348-0","title":"Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment","abstract":"BACKGROUND: The purpose of the Treatment for Harnessing Resiliency, Improving emotional regulation, and empowering indiViduals for a brighter future (THRIVE) study is to adapt an evidence-based posttraumatic stress disorder (PTSD) treatment for use among a polysubstance population receiving methadone maintenance treatment (MMT) at an opioid treatment program. Polysubstance use of high-risk combinations, such as illicit opioids and stimulants, is a critical public health issue. Individuals who engage in these high-risk combinations are more likely to have histories of childhood trauma, multiple traumas, PTSD, and greater PTSD severity as compared to mono-substance using individuals. Trauma, co-morbid mental health disorders such as PTSD, and polysubstance use complicate treatment outcomes. This study will use eight study phases to adapt an existing evidence-based PTSD intervention, Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT), via a massed treatment model (i.e., condensed treatment schedule) for patients in MMT who are engaged in sustained opioid-stimulant polysubstance use. METHODS AND ANALYSIS: The intervention is an adapted version of the STAIR-NT protocol. The massed version created includes four 60-min sessions of skill building and two weeks of four 60-min sessions of narrative therapy. A preliminary randomized controlled trial (RCT) with 80 participants, randomized 1:1, will be conducted to assess the intervention's implementation and impact on primary short-term outcomes of polysubstance use and PTSD symptoms. ETHICS AND DISSEMINATION: The results of this study will inform a fully-powered effectiveness trial for individuals with PTSD and polysubstance use receiving MMT. The findings are expected to provide valuable insights into improving both PTSD and substance use outcomes, and real-world implementation insights to integrating trauma-informed care in treatment settings for vulnerable populations. REGISTRATION: This study is registered at ClinicalTrials.Gov as NCT06307340. Registration date 03/2024.","journal":"BMC Psychiatry","year":2024,"id":474652,"datarank":0.10397207708399181,"base_score":0.6931471805599453,"endowment":0.6931471805599453,"self_citation_contribution":0.10397207708399181,"citation_network_contribution":0.0,"self_endowment_contribution":0.10397207708399181,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9483,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT06307340"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1287999,"name":"Brittany Griffin","orcid":null,"position":1,"is_corresponding":false},{"id":1311570,"name":"Vinodini Kumaravelu","orcid":null,"position":2,"is_corresponding":false},{"id":772400,"name":"Ana Ventuneac","orcid":"0000-0002-5186-4875","position":3,"is_corresponding":false},{"id":1158173,"name":"Michele Santacatterina","orcid":"0000-0003-0599-3876","position":4,"is_corresponding":false},{"id":632530,"name":"Amanda M. Bunting","orcid":"0000-0002-2103-9655","position":5,"is_corresponding":false},{"id":1054022,"name":"Tanya Renn","orcid":"0000-0002-4114-1411","position":0,"is_corresponding":true}],"reference_count":97,"raw_metadata":null,"created_at":"2026-07-19T02:06:13.042906Z","pmid":"39627789","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}