An interventional study of Digital therapy program (short) and Digital therapy program (long) in Depression and Anxiety, sponsored by University of Oslo. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
Among 21 studies in Depression by University of Oslo — 5 open to participants now, 5 under way, none of them phase 3. Depression · University of Oslo.
Among the 21 studies in Depression by University of Oslo, this one is one of 3 that started in 2026, is one of 8 with no phase, and was the 20th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →5 of the 21 studies in Depression by University of Oslo are open now, in 1 country. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2026.
Median enrollment 96 across the 8 interventional studies, 4,000 across the 13 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
2 of the studies in Depression by University of Oslo that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07000799University of OsloA Study of School Absenteeism and Student Well-being in Elementary Schools | 2026-12-31 |
| NCT07920107University of OsloFeasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment | 2027-02-15 |
Among the 21 studies in Depression by University of Oslo, from their registry updates:
The goal of this randomized pilot feasibility trial is to assess the feasibility and further develop a single-session digital mental health intervention for patients on waiting lists for psychological treatment. The main aims are:
Researchers will compare two different versions of the intervention (one longer and one shorter) with two control conditions (one active and one passive) to see if the study is feasible.
Participants will be randomized to one of the four conditions, do a short digital mental health intervention and fill out 4 questionnaires across a 5 week period.
Long waiting times in mental health services are associated with heightened distress, impaired daily functioning, and poorer treatment outcomes for individuals seeking help. Self-guided digital mental health interventions offer accessible and cost effective alternatives to traditional therapy, though engagement and dropout remain significant challenges. Single-session interventions (SSIs) have emerged as a promising solution, demonstrating meaningful reductions in symptoms such as depression, anxiety and eating disorders. SSIs might be a promising scalable treatment addition to patients on waiting lists for psychological treatment, but few studies specifically explore this, and understanding of mechanisms driving treatment response is limited. Recent calls have also been made to better understand how psychological interventions (such as SSIs) can be enhanced and extended beyond therapy-sessions and into patients daily lives.
This study is a pilot feasibility trial in preparation for a main trial aiming to develop and evaluate a digital, transdiagnostic single-session intervention for patients on waiting lists for psychological treatment. The main trial will also examine whether the effect of the SSI can be prolonged and enhanced in a scalable way through the introduction of Ecological momentary interventions (EMI).
A comprehensive development, testing and piloting phase will be completed to prepare for the main trial. This phase includes two pilot feasibility trials (one at each site) and one qualitative study. This trial registration refers to the first pilot feasibility trial, which will be conducted with the mild-moderate sample and will focus on developing the SSI and evaluating the feasibility of the full trial procedures, without introducing EMI. Participants from this trial will be recruited for qualitative interviews to provide feedback on the SSI, study procedures and their experiences of being on a waitlist.
In alignment with recommendations for pilot studies, no hypothesis testing will be conducted. We expect the study design to be feasible and anticipate that participant feedback will help optimize both the intervention and the procedures for the full trial.
Findings from this pilot feasibility trial may lead to one of three decisions:
In addition to being approved by The Norwegian Regional Committee for Medical and Health Research Ethics, this study was approved by the Norwegian Centre for Research Data.
The project is funded by Foundation Dam through the The Norwegian Council of Mental Health.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants complete the short digital therapy program (30-40 minutes) and answer questions about acceptability, feedback and interaction with other therapy.
Other: Digital therapy program (short)
Participants complete the long digital therapy program (45-55 minutes) and answer questions about acceptability, feedback and interaction with other therapy.
Other: Digital therapy program (long)
Participants receive advice and information intended to support mental health but do not complete the digital therapy program. They will still answer acceptability questions about the advice and interaction with therapy.
Other: Mental health advice
Participants do not receive any intervention materials and only complete mental health questionnaires. They will not answer acceptability questions.
This is a brief digital mental health program lasting for 30-40 minutes and includes text, self-reflection questions, and therapeutic exercises. Participants will learn and reflect on worrying and rumination behavior and how it impacts their life. The program only lasts for one session and is not module based. The intervention has been designed by the research team and is under development. This intervention is nested within Digital therapy program (long).
Also known as: AWARE OUT, single-session intervention - short
This is a brief digital mental health program lasting for 45-55 minutes and includes text, self-reflection questions, and therapeutic exercises. Participants will learn and reflect on worrying, rumination, avoidance and rigid attention behavior and how it impacts their life. The program only lasts for one session and is not module based. The intervention has been designed by the research team and is under development.
Also known as: AWARE OUT+, single-session intervention - long
ABC is a public health campaign about building and strengthening mental health for the entire population. The ABC messages: Do something active, do something together, and do something meaningful are meant to motivate people, municipalities, and organizations to take action to strengthen mental health. A description of the ABC framework is provided online by The Norwegian Directorate of Health and is implemented digitally as a set of advice ("ABC for god psykisk helse").
Also known as: ABC for good mental health, Act, Belong, Commit
Recruitement rates through the study period as assessed by number of participants providing informed consent, and the time it takes to finish recruitment
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants invited to participate in the study throughout the study period and the frequency of invitations
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants screened for eligibility throughout the study period.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants in each randomization arm.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of responses to each questionnaire and intervention representing missing data patterns and attrition across arms and measurement points
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
Number of participants who want to pull out of study or get data deleted throughout the study period
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
Acceptability of interventions and active control conditions as measured by the PFS and TCQ.
The PFS (program feedback scale) is a 7 item, 5 point scaled questionnaire asking questions about acceptability of digital single session interventions. The questionnaire has been adapted to Norwegian. It includes two open-ended feedback questions in addition to the rating questions. The TCQ (treatment credibility questionnaire) is a 5 item 10 point rating scale of credibility of treatment rationales. It is adapted to Norwegian and modified to fit to a digital therapy program. Only the first two items of the questionnaire is chosen.
Time frame: Assessed immediately after doing the intervention or the active control condition, which is on day 1-7 of the study period of 5 weeks. The passive control arm will not get these questions.
Time used to finish questionnaires and interventions
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: On each questionnaire and intervention, totaling 6 measurement times.
Timing of answers to questionnaires and completion of the study
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
Time frame: From the start of invitation to the end of the study at 6 weeks.
Belief about positive or negative interaction with planned treatment
As measured through 5 point rating scales of two items asking participants who have started treatment whether they believe the intervention will have a negative and/ or positive interaction with their current treatment.
Time frame: Asked at each measurement time after the baseline. This includes right after the intervention, at two week follow up and at 5 week follow up.
Self-reported depression and anxiety symptoms as assessed by PHQ-ADS
The PHQ-ADS (The Patient Health Questionnaire Anxiety and Depression Scale) is a composite measure of PHQ-9 (Patient Health Questionnaire - 9) and GAD-7 (Generalized Anxiety Disorder 7-item). The measure is taken through online questionnaires on the start of the study, two weeks after enrollment and five weeks after enrollment.
Time frame: Two weeks and five weeks after enrollment controlled by baseline at enrollment
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
Time frame: Approximate start: 12.03.2027
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.
Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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