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NCT Number: NCT07499219

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0316, Norway

About this study

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:

  • Continue with the study plan after minor changes to study procedures and the single-session intervention.
  • Continue with the study plan after major changes to the study procedures and the single session intervention.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital therapy program (short)

Other

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

Digital therapy program (long)

Other

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

Mental health advice

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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

  10. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2034
First posted
Mar 30, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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