NCT07499219

Preliminary Testing and Development of a Short Digital Intervention for Patients on Waiting Lists for Psychological Treatment

Developing a Web-based Transdiagnostic Single Session Intervention for Patients on Waiting Lists for Psychological Treatment: a Randomized Pilot Feasibility Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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: 1. To evaluate the feasibility and acceptability of the study procedures and the digital single-session intervention. 2. To gather quantitative and qualitative feedback on the intervention to inform further development. 3. To collect preliminary data to refine the analysis plan for a main trial. 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.

Detailed description

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: 1. Continue with the study plan after minor changes to study procedures and the single-session intervention. 2. Continue with the study plan after major changes to the study procedures and the single session intervention. 3. Reevaluate the study plan and possibly stop further exploration. 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.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
OTHER	Digital therapy program (short)	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).
OTHER	Digital therapy program (long)	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.
OTHER	Mental health advice	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").

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-06-15
• Completion: 2034-06-12
• First posted: 2026-03-30
• Last updated: 2026-03-30