Despite the established status of trauma-focused psychotherapy (TFP) as a first-line treatment for post-traumatic stress disorder (PTSD), a substantial proportion of individuals do not achieve clinically significant improvement or discontinue treatment. Exploring augmentation strategies to enhance treatment outcomes is essential to reduce the overall burden PTSD puts on individuals and society. This protocol outlines a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the efficacy of non-pharmacological augmentation strategies in addition to TFP for PTSD treatment.

We comprehensively searched PubMed, Embase, CENTRAL, PTSDpubs, PsycArticles, PsycINFO, PSYNDEX and CINAHL for RCTs without restrictions on publication dates or languages in October 2024. Study screening is currently ongoing. Additionally, we will perform forward and backward searches of the included studies and relevant reviews. Two reviewers will independently screen and select studies, extract data and assess the risk of bias. We will conduct a narrative review to qualitatively synthesise data and a meta-analysis to quantitatively compare the treatment efficacy of augmented TFP with TFP alone or TFP plus placebo. Primary outcomes will be both symptom severity and response rates. The secondary outcome will be dropout rates. We will explore sources of between-study heterogeneity and potential moderators through subgroup and meta-regression analyses. We will assess the overall quality of the included studies with the Grading of Recommendations Assessment, Development, and Evaluation system.

Ethical approval is not required. We intend to publish results in a peer-reviewed journal and provide materials and data through the Open Science Framework.

CRD42024549435.

Immigrant women frequently encounter ethnic discrimination (ED) and/or stressful events in their daily lives. To mitigate the risk of resulting health impairments, we developed an ecological momentary music intervention (EMMI-T) to reduce psychological and biological stress levels in the daily lives of Turkish immigrant women. The feasibility of the EMMI-T was confirmed in a pilot study (n=20). Here, we present the protocol of our proposed study to investigate the effectiveness of the EMMI-T.

Fifty Turkish immigrant women perceiving chronic ED will take part in the 35-day study. During all three study periods (ie, baseline, intervention and post-intervention), participants will use a smartphone-based app to provide discrimination-related and stress-related data four times a day. Additionally, they will report every discriminatory and/or stressful event. During the intervention period, subsequently after such event-based data entries, participants will be allocated to either an intervention event (music listening for 10 or 20 min) or a control event (no music listening). Irrespective of event type, the app will signal 20 min after the initial event-based data entry for additional data collection. Every data entry will be accompanied by the collection of a saliva sample for analysis of biological stress markers (alpha-amylase, cortisol).

This intraindividual randomised design will allow us to test immediate (ie, before vs after music listening) and intermediate (ie, baseline period vs postintervention period) effects of the EMMI-T on psychological and biological stress levels. To test our hypotheses, we will use multilevel modelling.

Positive ethical approval was given by the institutional review board of the University of Vienna (reference number 00575). The results of our study will be disseminated at conferences and submitted to a peer-reviewed journal.

NCT05829031.