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

April 27, 2026 updated by: Sverre Urnes Johnson, University of Oslo

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oslo
      • Oslo, Oslo, Norway, 0316
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short digital therapy program group
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)
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 Names:
  • AWARE OUT
  • single-session intervention - short
Experimental: Long digital therapy program group
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)
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 Names:
  • AWARE OUT+
  • single-session intervention - long
Placebo Comparator: Mental health advice group
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
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").
Other Names:
  • ABC for good mental health
  • Act, Belong, Commit
No Intervention: Questionnaire group
Participants do not receive any intervention materials and only complete mental health questionnaires. They will not answer acceptability questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitement rates through the study period as assessed by number of participants providing informed consent, and the time it takes to finish recruitment
Time Frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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
Time Frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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.
Time Frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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.
Time Frame: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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
Time Frame: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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
Time Frame: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
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.
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.

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.
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
Time Frame: On each questionnaire and intervention, totaling 6 measurement times.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
On each questionnaire and intervention, totaling 6 measurement times.
Timing of answers to questionnaires and completion of the study
Time Frame: From the start of invitation to the end of the study at 6 weeks.
This is part of evaluating the feasibility of the study procedures in preparation for a main trial
From the start of invitation to the end of the study at 6 weeks.
Belief about positive or negative interaction with planned 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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported depression and anxiety symptoms as assessed by PHQ-ADS
Time Frame: Two weeks and five weeks after enrollment controlled by baseline at enrollment
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.
Two weeks and five weeks after enrollment controlled by baseline at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Investigators

  • Principal Investigator: Sverre U Johnson, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2034

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILOTSIO945368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

No IPD will be shared outside of the research team involved with this study.

IPD Sharing Time Frame

Approximate start: 12.03.2027

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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