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

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.

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.

Inclusion Criteria:

• Must have applied for help at The Student Welfare Organization in Oslo and Akershus (SiO Mental Health) through their website.
• Must meet SiO Mental health's general eligibility criteria. This includes an individual screening of applications. SiOs general policy is to provide help to all applicants as long as they fulfill the requirement of being a student in the Oslo or Akershus area.
• Must speak and write Norwegian.
• Internet access and sufficient digital literacy is assumed among the student population.
• Willingness to be randomized.
• Willingness to partake in the study.
• Willingness to have data stored and used for the purpose of the current study.

Exclusion Criteria:

• No criteria excluding participants who meet the above mentioned inclusion criteria.