Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
NCT07920107, Not applicable, Not yet recruiting, University of Oslo
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment | ClinicalTrials.gov |
| NCT number | NCT07920107 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Oslo | ClinicalTrials.gov |
| Conditions | PTSD - Post Traumatic Stress Disorder, Depression, Anxiety, Complex Post-Traumatic Stress Disorder (CPTSD), Dissociation | ClinicalTrials.gov |
| Interventions | Digital self-administered web-based single-session intervention, While Waiting application: Ecological momentary assessments and interventions | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment flow counts | From recruitment initiation through the end of the 6-week study period. | Number of eligible patients, patients invited, participants providing informed consent, participants enrolled, dropouts, and withdrawals. Invitation is defined as receipt of a study invitation from study administrators. Consent is defined as submission of the consent form in Nettskjema.no. Enrollment is defined as initiation of m-Path interactions. Dropout is defined as not initiating the SSI, not completing any EMA prompts in study weeks 3 or 4, and being unreachable for clarification. Withdrawal is defined as communicating a wish to discontinue participation. | ClinicalTrials.gov |
| Primary | Recruitment rate | From invitation to participate until enrollment or classification as non-enrolled, assessed up to 4 months. | Recruitment rate is calculated as the number of enrolled participants divided by the number of eligible patients invited to participate. Value ranges from 0 to 1; higher values indicate higher recruitment rate. | ClinicalTrials.gov |
| Primary | Consent rate | From invitation to participate until provision of informed consent or classification as non-consented, assessed up to 4 months. | Consent rate is calculated as the number of eligible invited patients who provide informed consent divided by the number of eligible patients invited to participate. Value ranges from 0 to 1; higher values indicate greater consent uptake. | ClinicalTrials.gov |
| Primary | Consent-to-enrollment conversion rate | From provision of informed consent until enrollment or classification as non-enrolled, assessed up to 4 months. | Consent-to-enrollment conversion rate is calculated as the number of enrolled participants divided by the number of participants who provide informed consent. Values range from 0 to 1; higher values indicate greater consent-to-enrollment conversion rate. | ClinicalTrials.gov |
| Primary | Dropout rate | After enrollment throughout the 6-week study period | Dropout rate will be calculated as the number of dropouts divided by the number of enrolled participants. | ClinicalTrials.gov |
| Primary | Single-session intervention (SSI) engagement and completion | From SSI initiation through SSI completion, approximately 2 weeks after enrollment. | SSI engagement will be measured as the proportion of the SSI completed by each participant, calculated as the number of intervention web pages submitted by the participant through the Nettskjema.no portal divided by the total number of intervention pages (24). Values range from 0 to 1, where 0 indicates no pages completed and 1 indicates completion of all 24 pages. SSI completion will additionally be summarized as mean completion proportion across participants. Time spent completing the SSI will also be summarized where available. | ClinicalTrials.gov |
| Primary | Ecological momentary assessment (EMA) engagement, adherence and missing data | From enrollment through the end of the 6-week study period. | EMA adherence is measured as the proportion between number of completed EMA prompts and the number of scheduled and successfully delivered EMA prompts. Values range from 0 to 1, where higher values indicate greater EMA adherence. Participant-level and mean-level EMA adherence will be calculated. Time spent completing EMA prompts will also be summarized descriptively, where available. EMA missing-data proportion will be calculated as 1-EMA adherence. | ClinicalTrials.gov |
| Primary | Ecological momentary intervention (EMI) engagement and adherence | During the 2-week EMI phase, approximately weeks 2-4 after enrollment. | Engagement with EMI recommendations is calculated as the number of delivered EMI recommendations for which the participant completes at least one recommended EMI activity divided by the number of delivered EMI recommendations. Values range from 0 to 1, where higher values indicate greater engagement with EMI recommendations. Participant-level and mean-level EMI engagement with recommendations will be calculated. Supplementary descriptive usage metrics will include the number of EMI recommendations delivered, intervention activities initiated and completed, and time spent completing intervention components, where available. | ClinicalTrials.gov |
| Primary | Ecological momentary assessment (EMA) retention | Enrollment through week 6 | Proportion of enrolled participants who complete at least one EMA response during week 6. Values range from 0 to 1 with higher values indicate greater retention through the EMA period. | ClinicalTrials.gov |
| Primary | Adverse events | From consent through the end of the 6-week study period. | Number and nature of adverse events and unexpected circumstances. Participants have the opportunity to report events to the study administrators, and these will be summarized qualitatively. Evaluation of this measure is descriptive. | ClinicalTrials.gov |
| Primary | Ease of use of the While Waiting application | 1 week after enrollment. | Participant-rated ease of using the While Waiting application. Assessed with one study-specific item inspired by Bringmann et al. (2025): "How easy is it to use the While Waiting application?" The item is rated from 1 ("very difficult") to 10 ("very easy"). Higher scores indicate greater perceived ease of use. | ClinicalTrials.gov |
| Primary | Positive emotional impact of answering Ecological momentary assessment (EMA) questions | 1 week after enrollment. | Participant-rated positive emotional impact of answering EMA questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "To what extent are your emotions positively affected by answering questions in the While Waiting application?" The item is rated from 1 ("not affected at all") to 10 ("very affected"). Higher scores indicate greater perceived positive emotional impact. | ClinicalTrials.gov |
| Primary | Negative emotional impact of Ecological momentary assessment (EMA) questions | 1 week after enrollment. | Participant-rated negative emotional impact of answering questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "To what extent are your emotions negatively affected by answering questions in the While Waiting application?" The item is rated from 1 ("not affected at all") to 10 ("very affected"). Scores will be reverse-coded such that higher scores indicate less perceived negative emotional impact. | ClinicalTrials.gov |
| Primary | Perceived burden of Ecological momentary assessment (EMA) questionnaire length | 1 week after enrollment. | Participant-rated burden associated with the number of questions in the While Waiting application, assessed with one study-specific item inspired by Bringmann et al. (2025): "How burdensome is the number of questions in the While Waiting application?" The item is rated from 1 ("not burdensome") to 10 ("very burdensome"). Scores will be reverse-coded such that higher scores indicate lower perceived burden. | ClinicalTrials.gov |
| Primary | Feedback and engagement with the Single-session intervention (SSI) | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant-rated feedback and engagement with the SSI, assessed using the 7 quantitative items from the Program Feedback Scale (PFS; Schleider et al., 2019). Items assess willingness to recommend the SSI, agreement with its message, perceived helpfulness for peers, effort during the SSI, understanding of the SSI, ease of use, and enjoyment. Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the seven selected PFS items, ranging from 1 to 5. Higher scores indicate more favorable feedback and engagement. | ClinicalTrials.gov |
| Primary | Perceived appropriateness of the Single-session intervention (SSI) | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant-rated perceived appropriateness of the SSI, assessed using two selected items from the Intervention Appropriateness Measure (IAM; Weiner et al., 2017): "AWARE OUT seems applicable" and "AWARE OUT seems like a good match." Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the two selected items, ranging from 1 to 5. Higher scores indicate greater perceived appropriateness of the SSI. | ClinicalTrials.gov |
| Primary | Treatment credibility: confidence that the Single-session intervention (SSI) will help | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant confidence that the SSI will help them with their psychological challenges and troubles. Assessed using one item from the Treatment Credibility Questionnaire (TCQ; Borkovec \& Nau, 1972): "How confident are you that AWARE OUT will help you with your psychological challenges and troubles?" The item is rated on a 1-10 scale. Higher scores indicate greater perceived treatment credibility. | ClinicalTrials.gov |
| Primary | Intention to use the Single-session intervention (SSI) | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant-rated intention to use the SSI, assessed using one item from the System Usability Scale (SUS; Lewis, 2018): "I think that I would use what I learnt in AWARE OUT going forward." The item is rated on a 1-5 Likert scale. Higher scores indicate greater intention or willingness to use the SSI frequently. | ClinicalTrials.gov |
| Primary | Perceived negative effects of the Single-session intervention (SSI) | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant-rated negative effects of the SSI, assessed using the study-developed item: "Completing AWARE OUT has affected me negatively." The item is rated on a 1-5 Likert scale. The item will be reverse-coded so that higher scores indicate fewer perceived negative effects. | ClinicalTrials.gov |
| Primary | Perceived novelty of the Single-session intervention (SSI) | Immediately after completion of the SSI, approximately 2 weeks after enrollment. | Participant-rated perceived novelty of the SSI, assessed using the study-developed item: "I learned something new through AWARE OUT." The item is rated on a 1-5 Likert scale. Higher scores indicate greater perceived novelty or learning. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)