Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07920107). This is a study registration, not published results. Lead sponsor: University of Oslo. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: PTSD - Post Traumatic Stress Disorder, Depression, Anxiety, Complex Post-Traumatic Stress Disorder (CPTSD), Dissociation. Interventions: OTHER: Digital self-administered web-based single-session intervention; OTHER: While Waiting application: Ecological momentary assessments and interventions. Primary outcome measures: Recruitment flow counts , From recruitment initiation through the end of the 6-week study period.; Recruitment rate , From invitation to participate until enrollment or classification as non-enrolled, assessed up to 4 months.; Consent rate , From invitation to participate until provision of informed consent or classification as non-consented, assessed up to 4 months.; Consent-to-enrollment conversion rate , From provision of informed consent until enrollment or classification as non-enrolled, assessed up to 4 months.; Dropout rate , After enrollment throughout the 6-week study period; Single-session intervention (SSI) engagement and completion , From SSI initiation through SSI completion, approximately 2 weeks after enrollment.; Ecological momentary assessment (EMA) engagement, adherence and missing data , From enrollment through the end of the 6-week study period.; Ecological momentary intervention (EMI) engagement and adherence , During the 2-week EMI phase, approximately weeks 2-4 after enrollment.; Ecological momentary assessment (EMA) retention , Enrollment through week 6; Adverse events , From consent through the end of the 6-week study period.; Ease of use of the While Waiting application , 1 week after enrollment.; Positive emotional impact of answering Ecological momentary assessment (EMA) questions , 1 week after enrollment.; Negative emotional impact of Ecological momentary assessment (EMA) questions , 1 week after enrollment.; Perceived burden of Ecological momentary assessment (EMA) questionnaire length , 1 week after enrollment.; Feedback and engagement with the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Perceived appropriateness of the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Treatment credibility: confidence that the Single-session intervention (SSI) will help , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Intention to use the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Perceived negative effects of the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Perceived novelty of the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Perceived appropriateness of Single-session intervention (SSI) length , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Exercise preferences in the Single-session intervention (SSI) , Immediately after completion of the SSI, approximately 2 weeks after enrollment.; Usability and quality of the While Waiting application , At the end of the EMI phase, approximately 4 weeks after enrollment.; Perceived impact of the While Waiting application , At the end of the EMI phase, approximately 4 weeks after enrollment.; While Waiting application feedback: Helpfulness, recommendation, enjoyment, and ease of use , At the end of the EMI phase, approximately 4 weeks after enrollment; Treatment credibility: confidence that the While Waiting application will help , At the end of the EMI phase, approximately 4 weeks after enrollment; Study feedback: perceived participant experience and burden , At the end of the study period at approximately week 6 after enrollment.. Brief summary: This clinical trial examines whether a self-administered web-based single-session intervention named AWARE OUT, combined with Ecological Momentary Assessments (EMA) and Ecological Momentary Interventions (EMI), can be feasibly delivered to patients with post-traumatic stress disorder (PTSD) and dissociative symptoms who are awaiting psychological treatment.