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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short digital therapy program group | Experimental | Participants complete the short digital therapy program (30-40 minutes) and answer questions about acceptability, feedback and interaction with other therapy. |
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| Long digital therapy program group | Experimental | Participants complete the long digital therapy program (45-55 minutes) and answer questions about acceptability, feedback and interaction with other therapy. |
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| Mental health advice group | Placebo Comparator | 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. |
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| Questionnaire group | No Intervention | Participants do not receive any intervention materials and only complete mental health questionnaires. They will not answer acceptability questions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 | 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 | 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. | 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sverre U Johnson, PhD | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Oslo | Oslo | 0316 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Borkovec, T. D., & Nau, S. D. (1972). Credibility of Analogue Therapy Rationales. Journal of Behavior Therapy and Experimental Psychiatry, 3(4), 257-260. https://doi.org/10.1016/0005-7916(72)90045-6 | ||
| 39874601 | Background | Schleider JL, Zapata JP, Rapoport A, Wescott A, Ghosh A, Kaveladze B, Szkody E, Ahuvia IL. Single-Session Interventions for Mental Health Problems and Service Engagement: Umbrella Review of Systematic Reviews and Meta-Analyses. Annu Rev Clin Psychol. 2025 May;21(1):279-303. doi: 10.1146/annurev-clinpsy-081423-025033. Epub 2025 Jan 28. | |
| 39443071 |
| Label | URL |
|---|---|
| Project site in Norwegian with information and updates on the project. | View source |
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No IPD will be shared outside of the research team involved with this study.
Approximate start: 12.03.2027
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.
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Randomization is performed automatically without any human involvement. The automated system reflects the absence of researcher influence during assignment. For this reason, no "investigator" will be aware of the assigned treatments during data collection.
Participants will be informed that randomization is part of the study procedures, but they will not be explicitly told which group they have been assigned to. Although participants may infer their group allocation based on the questionnaires or intervention, the presence of four groups and the overlap between intervention components (e.g., nesting), may create some uncertainty about group membership. This uncertainty may function as a form of soft blinding, at least during the early phase of study participation (e.g., the first week).
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| 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. |
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| 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"). |
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| 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 | 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. | 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 | 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 | 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. | 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. |
| Two weeks and five weeks after enrollment controlled by baseline at enrollment |
| Background |
| Ramos G, Hernandez-Ramos R, Taylor M, Schueller SM. State of the Science: Using Digital Mental Health Interventions to Extend the Impact of Psychological Services. Behav Ther. 2024 Nov;55(6):1364-1379. doi: 10.1016/j.beth.2024.04.004. Epub 2024 Apr 10. |
| 31290406 | Background | Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368. |
| 40604240 | Background | Smith KA, Ward T, Lambe S, Ostinelli EG, Blease C, Gant T, Gold SM, Holmes EA, Paccoud I, Vinnikova A, Klucken J, Uhlhaas PJ, Sanchez CG, Haining K, Boge K, Lahutina S, Tomelleri L, Ryan S, Torous J, Cipriani A. Engagement and attrition in digital mental health: current challenges and potential solutions. NPJ Digit Med. 2025 Jul 2;8(1):398. doi: 10.1038/s41746-025-01778-w. |
| 38390026 | Background | Lipschitz JM, Pike CK, Hogan TP, Murphy SA, Burdick KE. The engagement problem: A review of engagement with digital mental health interventions and recommendations for a path forward. Curr Treat Options Psychiatry. 2023 Sep;10(3):119-135. doi: 10.1007/s40501-023-00297-3. Epub 2023 Aug 25. |
| 36372129 | Background | van Dijk DA, Meijer RM, van den Boogaard TM, Spijker J, Ruhe HG, Peeters FPML. Worse off by waiting for treatment? The impact of waiting time on clinical course and treatment outcome for depression in routine care. J Affect Disord. 2023 Feb 1;322:205-211. doi: 10.1016/j.jad.2022.11.011. Epub 2022 Nov 11. |
| 27445199 | Background | Steinert C, Stadter K, Stark R, Leichsenring F. The Effects of Waiting for Treatment: A Meta-Analysis of Waitlist Control Groups in Randomized Controlled Trials for Social Anxiety Disorder. Clin Psychol Psychother. 2017 May;24(3):649-660. doi: 10.1002/cpp.2032. Epub 2016 Jul 22. |
| 27154047 | Background | Thielen FW, Ten Have M, de Graaf R, Cuijpers P, Beekman A, Evers S, Smit F. Long-term economic consequences of child maltreatment: a population-based study. Eur Child Adolesc Psychiatry. 2016 Dec;25(12):1297-1305. doi: 10.1007/s00787-016-0850-5. Epub 2016 May 6. |
| 26978655 | Background | Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016. |
| 38606504 | Background | Ke S, Zhang B, He Y, Zhou Y, Hu X, Fan Y, Wang M, Zhang Y, Wang C. Reconstruction Strategy for Upper Extremity Defects After Bone Tumor Resection Based on 3D Customized Bone Cement Mold. Surg Innov. 2024 Jun;31(3):307-317. doi: 10.1177/15533506241244493. Epub 2024 Apr 12. |
| 35551058 | Background | Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159. |
| Background | ABC for god psykisk helse. (2019, December 5). https://www.helsenorge.no/psykisk-helse/abc-for-god-psykisk-helse/ |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| C106538 | abacavir |
| D000514 | alpha 1-Antichymotrypsin |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000510 | Alpha-Globulins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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