PTSD - Post Traumatic Stress DisorderNCT07920107
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
A study testing Digital self-administered web-based single-session intervention and While Waiting application: Ecological momentary assessments and interventions in people with PTSD - Post Traumatic Stress Disorder and Depression, run by University of Oslo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Depression, Anxiety
- What is being tested?
- Digital self-administered web-based single-session intervention and While Waiting application: Ecological momentary assessments and interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2026to Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Psychosis
- Substance abuse during the last three months
- Severe somatic illness (i.e., requiring hospitalization)
- Acute suicidality
- Current life crisis (e.g., loss of a child, divorce)
- Severely disturbed group functioning (e.g., hostile, or sexually inappropriate behavior).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Scalable Mental Health Interventions and Mechanisms for PTSD
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.
Read the detailed description
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)
- To descriptively explore changes in PTSD symptoms and combined depression and anxiety symptoms from baseline through the six week study period.
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
- Conditions
- PTSD - Post Traumatic Stress Disorder, Depression, Anxiety, Complex Post-Traumatic Stress Disorder (CPTSD), Dissociation
- Being tested
- Digital self-administered web-based single-session intervention, While Waiting application: Ecological momentary assessments and interventions
- Keywords
- cptsd, pilot feasibility trial, mental health, digital therapy, digital mental health intervention, single-session intervention, anxiety, depression, ptsd, ecological momentary intervention, ecological momentary assessment
- Medical subject headings
- Combat Disorders, Depression, Anxiety Disorders, Dissociative Disorders, Psychological Well-Being, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital self-administered web-based single-session interventionOther
Also called AWARE OUT, SSI
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.
While Waiting application: Ecological momentary assessments and interventionsOther
Also called m-Path, EMA, EMI, Mens-du-venter appen
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-session intervention and ecological momentary assessment / intervention arm | Experimental | 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. Receives: Other: Digital self-administered web-based single-session intervention; Other: While Waiting application: Ecological momentary assessments and interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the end of the study period at approximately week 6 after enrollment.
Secondary outcomes (2)
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).
Measured: 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).
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start9 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Sverre U Johnson, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920107
- Sponsor's protocol ID
- PILOTMODUM998878
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No IPD will be shared outside of the research team involved with this study.
Publications
Wisting L, Johnson SU, Bulik CM, Andreassen OA, Ro O, Bang L. Psychometric properties of the Norwegian version of the Patient Health Questionnaire-9 (PHQ-9) in a large female sample of adults with and without eating disorders. BMC Psychiatry. 2021 Jan 5;21(1):6. doi: 10.1186/s12888-020-03013-0.
PubMed 33402149Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
PubMed 31447721Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
PubMed 27187854Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
PubMed 27287964Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Bringmann LF, Tolmeijer E, Piot M, Mestdagh M, Verdonck S, Stulp G, Waite F, Isham L, Staring APB, Freeman D, van den Berg D. Developing a qualitative and quantitative ambulatory assessment-based feedback system within cognitive behavioural interventions for people with persecutory beliefs. Internet Interv. 2025 Mar 20;40:100819. doi: 10.1016/j.invent.2025.100819. eCollection 2025 Jun.
PubMed 40206212Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.
PubMed 31290406
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalable Mental Health Interventions and Mechanisms for PTSD
- ClinicalTrials.gov ID
- NCT07920107
- Acronym / sponsor ID
- PILOTMODUM998878
- Conditions
- PTSD - Post Traumatic Stress Disorder, Depression, Anxiety, Complex Post-Traumatic Stress Disorder (CPTSD), Dissociation
- Keywords
- cptsd, pilot feasibility trial, mental health, digital therapy, digital mental health intervention, single-session intervention, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
- To descriptively explore changes in PTSD symptoms and combined depression and anxiety symptoms from baseline through the six week study period.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-session intervention and ecological momentary assessment / intervention arm | Experimental | Other: Digital self-administered web-based single-session intervention, Other: While Waiting application: Ecological momentary assessments and interventionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Psychosis
- Substance abuse during the last three months
- Severe somatic illness (i.e., requiring hospitalization)
- Acute suicidality
- Current life crisis (e.g., loss of a child, divorce)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital self-administered web-based single-session interventionAlso: AWARE OUT, SSIA 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. | Other | Single-session intervention and ecological momentary assessment / intervention arm |
| While Waiting application: Ecological momentary assessments and interventionsAlso: m-Path, EMA, EMI, Mens-du-venter appenA 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. | Other | Single-session intervention and ecological momentary assessment / intervention arm |
Primary outcome
Recruitment flow counts
Time frame: 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.
Recruitment rate
Time frame: 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.
Consent rate
Time frame: 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.
Consent-to-enrollment conversion rate
Time frame: 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.
Dropout rate
Time frame: 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.
Single-session intervention (SSI) engagement and completion
Time frame: 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.
Ecological momentary assessment (EMA) engagement, adherence and missing data
Time frame: 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.
Ecological momentary intervention (EMI) engagement and adherence
Time frame: 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.
Ecological momentary assessment (EMA) retention
Time frame: 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.
Adverse events
Time frame: 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.
Ease of use of the While Waiting application
Time frame: 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.
Positive emotional impact of answering Ecological momentary assessment (EMA) questions
Time frame: 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.
Negative emotional impact of Ecological momentary assessment (EMA) questions
Time frame: 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.
Perceived burden of Ecological momentary assessment (EMA) questionnaire length
Time frame: 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.
Feedback and engagement with the Single-session intervention (SSI)
Time frame: 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.
Perceived appropriateness of the Single-session intervention (SSI)
Time frame: 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.
Treatment credibility: confidence that the Single-session intervention (SSI) will help
Time frame: 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.
Intention to use the Single-session intervention (SSI)
Time frame: 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.
Perceived negative effects of the Single-session intervention (SSI)
Time frame: 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.
Perceived novelty of the Single-session intervention (SSI)
Time frame: 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.
Perceived appropriateness of Single-session intervention (SSI) length
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
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.
Exercise preferences in the Single-session intervention (SSI)
Time frame: Immediately after completion of the SSI, approximately 2 weeks after enrollment.
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
Usability and quality of the While Waiting application
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment.
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.
Perceived impact of the While Waiting application
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment.
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.
While Waiting application feedback: Helpfulness, recommendation, enjoyment, and ease of use
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment
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.
Treatment credibility: confidence that the While Waiting application will help
Time frame: At the end of the EMI phase, approximately 4 weeks after enrollment
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.
Study feedback: perceived participant experience and burden
Time frame: At the end of the study period at approximately week 6 after enrollment.
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
2 secondary outcomes
PTSD symptom severity
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Depression and anxiety symptom severity
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 33402149Wisting L, Johnson SU, Bulik CM, Andreassen OA, Ro O, Bang L. Psychometric properties of the Norwegian version of the Patient Health Questionnaire-9 (PHQ-9) in a large female sample of adults with and without eating disorders. BMC Psychiatry. 2021 Jan 5;21(1):6. doi: 10.1186/s12888-020-03013-0.
- Background: PubMed 31447721Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
- Background: PubMed 27187854Kroenke K, Wu J, Yu Z, Bair MJ, Kean J, Stump T, Monahan PO. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials. Psychosom Med. 2016 Jul-Aug;78(6):716-27. doi: 10.1097/PSY.0000000000000322.
- Background: PubMed 27287964Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 40206212Bringmann LF, Tolmeijer E, Piot M, Mestdagh M, Verdonck S, Stulp G, Waite F, Isham L, Staring APB, Freeman D, van den Berg D. Developing a qualitative and quantitative ambulatory assessment-based feedback system within cognitive behavioural interventions for people with persecutory beliefs. Internet Interv. 2025 Mar 20;40:100819. doi: 10.1016/j.invent.2025.100819. eCollection 2025 Jun.
- Background: PubMed 31290406Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.
- Individual participant dataSharing planned: Yes. No IPD will be shared outside of the research team involved with this study.
Related trials for PTSD - Post Traumatic Stress Disorder
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sverre U Johnson, PhD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Digital self-administered web-based single-session intervention and While Waiting application: Ecological momentary assessments and interventions in people with PTSD - Post Traumatic Stress Disorder and Depression, run by University of Oslo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Gustav F Ikonomeas, Candidate of Psychology (+4746503688, agikonom@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment flow counts (time frame: From recruitment initiation through the end of the 6-week study period.). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07920107, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.