An interventional study of Digital self-administered web-based single-session intervention and While Waiting application: Ecological momentary assessments and interventions in PTSD - Post Traumatic Stress Disorder, Depression and Anxiety, sponsored by University of Oslo. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
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.
Primary objective(s)
To evaluate the feasibility of the transdiagnostic scalable single-session intervention AWARE OUT in conjunction with Ecological Momentary Assessments (EMA) and Ecological Momentary Interventions (EMI) for a severe clinical sample with PTSD and dissociation symptoms while on waiting list for psychological mental health treatment. This will inform whether a definitive RCT is warranted to assess the effect of the intervention among this particular patient group in this context.
Secondary Objective(s)
About assessment and usage of measurements:
The primary outcome is feasibility, conceptualized as a higher-order construct comprising several distinct but related outcomes: uptake, retention, acceptability and appropriateness, fidelity, as well as study-feasibility and safety of the intervention and study procedures. Because the intervention is measurement-based, intervention delivery and study procedures overlap, and several measures serve both purposes. We assess whether participants perceive the intervention and study participation as acceptable, appropriate, useful, and safe, as well as whether the intervention and study procedures can be successfully delivered and completed as intended. We additionally evaluate participant uptake, engagement, retention, and recruitment to determine whether a larger and more formal evaluation of intervention effectiveness would be feasible. Several measures relate specifically to the SSI, EMA, or EMI components, whereas others concern the study as a whole.
Progression criteria:
Progression to a full RCT will be guided by the traffic-light criteria below, descriptive summaries outcome measures defined above. One or more orange ratings will indicate that progression may be warranted following modifications to the intervention or study procedures. Any red rating will lead to a review of the relevant criteria before determining to redesign, conduct an additional pilot or progress after modifications. Criteria have been defined by the research team after discussions. They are based on pragmatic considerations (e.g. what recruitment levels are needed to invest in a full trial) as well as descriptions by clinical staff on site.
Green: proceed with minor/no modifications. Orange: proceed after modifications. Red: do not proceed without substantial modifications.
Recruitment Green: At least 15 participants enrolled during the recruitment period, and at least 40% of eligible invited patients consent. Orange: 10-14 participants enrolled, or 25-39% of eligible invited patients consent. Red: Fewer than 10 participants enrolled or less than 25% of eligible invited patients consent.
EMA retention/adherence Green: At least 70% of enrolled participants remain in the study through the EMA period (six weeks), and participants respond to at least 60% of scheduled EMA prompts on average. Orange: 50-69% remain through the EMA period, or mean response rate is 40-59%. Red: Less than 50% remain through the EMA period, or mean response rate is below 40%.
SSI retention/completion Green: At least 70% of enrolled participants complete at least 50% of the SSI. Orange: 50-69% of enrolled participants complete at least 50% of the SSI.
Red: Fewer than 50% of enrolled participants complete at least 50% of the SSI.
EMI retention and engagement/usage Green: Participants complete on average at least one intervention in 60% of the EMIs that provide a recommendation. Orange: Minimum one EMI completion when recommended is 40-59% on average. Red: Minimum one EMI completion when recommended is below 40% on average.
Acceptability/helpfulness/appropriateness of EMA Green: Rating of at least 6 on 1-10 quantitative feedback questions. Orange: Mean rating 5-5.99. Red: Mean rating below 5.
Acceptability/helpfulness/appropriateness of SSI Green: Rating at least 3.5 on a 1-5 scale for quantitative feedback questions. (Items on a different scale will be rescaled to 1-5). Orange: Mean rating 3-3.49. Red: Mean rating below 3.
Acceptability/helpfulness/appropriateness of EMI Green: Mean rating at least 3.5 on a 1-5 scale for quantitative feedback questions (Items on a different scale will be rescaled to 1-5). Orange: Mean rating 3-3.49. Red: Mean rating below 3.
Safety and adverse experiences Green: No serious study-related adverse events. Orange: Non-serious adverse experiences or burden concerns requiring procedural or content modifications. Red: Any serious intervention-related adverse event, or concerning deterioration in mental health outcomes reported by participants and explicitly attributed to study-participation
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible for the current study, patients must be admitted to the waiting-period before in-patient treatment at the Modum bad trauma-clinic. Inclusion criteria are
Exclusion criteria include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete 2 weeks of EMA, followed by the self-guided AWARE OUT intervention, 2 weeks of personalized EMA/EMI via the While Waiting Application, and a final 2 weeks of EMA. The While Waiting Application is implemented within the m-Path application.
Other: Digital self-administered web-based single-session intervention · Other: While Waiting application: Ecological momentary assessments and interventions
A 30-40-minute self-guided digital intervention targeting PTSD-related difficulties and transdiagnostic processes. It provides psychoeducation and brief exercises targeting avoidance, worry, rumination, and rigid attention. Exercises include behavioral activation, postponement of worry and rumination, and attentional shifting. The intervention is delivered through videos, text, examples, and written tasks.
Also known as: AWARE OUT, SSI
A mobile-based program comprising brief ecological momentary assessments completed 4 times daily and personalized, in-the-moment intervention prompts. Prompts support skills such as attention shifting, postponing worry/rumination, behavioral activation, challenging avoidance, and physiological regulation.
Also known as: m-Path, EMA, EMI, Mens-du-venter appen
Recruitment flow counts
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.
Time frame: From recruitment initiation through the end of the 6-week study period.
Recruitment rate
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.
Time frame: From invitation to participate until enrollment or classification as non-enrolled, assessed up to 4 months.
Consent rate
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.
Time frame: From invitation to participate until provision of informed consent or classification as non-consented, assessed up to 4 months.
Consent-to-enrollment conversion rate
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.
Time frame: From provision of informed consent until enrollment or classification as non-enrolled, assessed up to 4 months.
Dropout rate
Dropout rate will be calculated as the number of dropouts divided by the number of enrolled participants.
Time frame: After enrollment throughout the 6-week study period
Single-session intervention (SSI) engagement and completion
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.
Time frame: From SSI initiation through SSI completion, approximately 2 weeks after enrollment.
Ecological momentary assessment (EMA) engagement, adherence and missing data
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.
Time frame: From enrollment through the end of the 6-week study period.
Ecological momentary intervention (EMI) engagement and adherence
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.
Time frame: During the 2-week EMI phase, approximately weeks 2-4 after enrollment.
Ecological momentary assessment (EMA) retention
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.
Time frame: Enrollment through week 6
Adverse events
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.
Time frame: From consent through the end of the 6-week study period.
Ease of use of the While Waiting application
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.
Time frame: 1 week after enrollment.
Positive emotional impact of answering Ecological momentary assessment (EMA) questions
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.
Time frame: 1 week after enrollment.
Negative emotional impact of Ecological momentary assessment (EMA) questions
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.
Time frame: 1 week after enrollment.
Perceived burden of Ecological momentary assessment (EMA) questionnaire length
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.
Time frame: 1 week after enrollment.
Feedback and engagement with the Single-session intervention (SSI)
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived appropriateness of the Single-session intervention (SSI)
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Treatment credibility: confidence that the Single-session intervention (SSI) will help
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Intention to use the Single-session intervention (SSI)
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived negative effects of the Single-session intervention (SSI)
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived novelty of the Single-session intervention (SSI)
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.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Perceived appropriateness of Single-session intervention (SSI) length
Participant-rated appropriateness of SSI length, assessed using the study-developed item: "On a scale from 1 (far too short) to 10 (far too long), where 5 is just right, what do you think about the length of AWARE OUT?" The item is rated from 1 to 10, with 5 indicating the most appropriate length. The outcome will be the absolute deviation from 5: absolute value of (participant length rating-5). Scores range from 0 to 5. Lower scores indicate that the participant perceived the SSI length as closer to "just right"; a score of 0 indicates a rating of exactly 5.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Exercise preferences in the Single-session intervention (SSI)
Two multiple choice questions regarding which exercise they prefer, and which they least prefer. There are three exercises in the SSI, meaning they have to chose one out of the three as their preferred / least preferred choice in each question
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Usability and quality of the While Waiting application
Participant-rated usability and quality of the While Waiting application, assessed using 8 selected items from the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016). Items assess engagement/interest (1 item), functionality (2 items: ease of use and navigation), aesthetics (2 items: layout and visual appeal), and information quality (3 items: quality, quantity, and visual presentation of information). Each item is rated on a 1-5 scale. The outcome will be the mean score across the eight selected items, ranging from 1 to 5. Higher scores indicate more favorable perceived application usability and quality.
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment.
Perceived impact of the While Waiting application
Participant-rated perceived impact of the While Waiting application, assessed using 5 app-specific questions adapted from the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016). Items assess whether use of the application increased participants' awareness of, knowledge about, attitudes toward, intention or motivation to address, and anticipated behavior change related to the target health behavior. Each item is rated on a 1-5 Likert scale. The outcome will be the mean score across the five items, ranging from 1 to 5; higher scores indicate greater perceived positive impact of the application.
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment.
While Waiting application feedback: Helpfulness, recommendation, enjoyment, and ease of use
Participant-rated feedback on the While Waiting application will be assessed using four selected items from the Program Feedback Scale (PFS; Schleider et al., 2019). The items assess perceived helpfulness for others having same difficulties, willingness to recommend the app to someone they know experiencing a difficult time, enjoyment of the app, and perceived ease of use. Each item is rated on a 1-5 Likert scale. The primary outcome will be the mean score across the four selected items, ranging from 1 to 5. Higher scores indicate more favorable feedback, including greater perceived helpfulness, recommendation, enjoyment, and ease of use.
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment
Treatment credibility: confidence that the While Waiting application will help
Participant confidence that the While waiting application will help them with their problems. Assessed with one item from the Treatment Credibility Questionnaire (TCQ; Borkovec \& Nau, 1972): "How confident are you that the While Waiting application will help you with your psychological challenges and troubles?" The item is scored on a 1-10 scale. Higher scores indicate greater perceived treatment credibility.
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment
Study feedback: perceived participant experience and burden
Participant feedback on study participation and answering questions in the While Waiting application will be assessed at 6 weeks after enrollment using five study-specific items adapted from Bringmann et al. (2025). Three items assess perceived burden, positive emotions, and negative emotions associated with answering questions in the application. One item assesses how positive it was to participate in the project, and one item assesses perceived burden of participating in the project. All items are rated on a 1-10 scale. Negatively worded items will be reverse-coded so that higher scores consistently indicate a more positive participant experience (i.e., greater positive emotions/experience and lower perceived burden and negative emotions). The outcome will be the mean score across the five recoded items, ranging from 1 to 10. Higher scores indicate a more positive overall participant experience, including greater positive emotions and lower perceived burden and negative emotions
Time frame: At the end of the study period at approximately week 6 after enrollment.
PTSD symptom severity
PTSD symptom severity assessed using the PTSD Checklist for DSM-5 (PCL-5, Weathers et al., 2013). The PCL-5 is a 20-item questionnaire that measures DSM-5-specified symptoms of PTSD. The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ('not at all') to 4 ('extremely') Likert-type scale. A Norwegian version of the PCL-5 is used in the current study (Heir, T., 2014).
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Depression and anxiety symptom severity
Combined depression and anxiety symptom severity assessed using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS; Kroenke et al., 2016). PHQ-ADS consists of 16 questions and scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety). Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3, respectively. A Norwegian version of the PHQ-ADS is used in the current study (Johnson et al., 2019; Wisting et al., 2021).
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Open ended feedback of the While waiting application
Open ended feedback of the While waiting application will be measured using four items focusing on 1) what the participant liked, 2) what they wish was different, 3) what was most helpful and 4) what they disliked about the application.
Time frame: Item 1, 2 and 4 will be asked two times, after the EMI-phase (week 4 after enrollment) and at the end of the study period (week 6 after enrollment). Item 3 will only be asked after the EMI-phase (week 4 after enrollment)
Open ended feedback of the Single-session intervention (SSI)
Open ended feedback of the SSI will be measured using three items focusing on what the participant liked, what they wish was different and what they disliked about the intervention.
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
Open ended feedback of the While waiting application
Open ended feedback of the While waiting application will be measured using three items focusing on what the participant liked, what they wish was different and what they disliked about the application overall.
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment
No study locations are listed for this record.
Plan to share: Yes — No IPD will be shared outside of the research team involved with this study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Access criteria: Simplified version of study Protocol is available on Open science framework (osf.io). Comprehensive study protocol can be made available upon reasonable requets.Simple SAP is available on osf.io.Simplified version of ICF can be shared upon reasonable requests. Analytic code will be made available after publication of study in peer review journal, and will be shared upon reasonable requests.
Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 4 months is below that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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