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

NCT07499219 | Enrolling By Invitation

• 1 other identifier: PILOTSIO945368
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Depression

Keywords

depression; anxiety; single-session intervention; digital mental health intervention; digital therapy; mental health; pilot feasibility trial

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

Secondary Outcomes (1)

• Self-reported depression and anxiety symptoms as assessed by PHQ-ADS

  Two weeks and five weeks after enrollment controlled by baseline at enrollment

Study Arms (4)

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.

Other: Digital therapy program (short)

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.

Other: Digital therapy program (long)

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.

Other: Mental health advice

Questionnaire group

NO INTERVENTION

Participants do not receive any intervention materials and only complete mental health questionnaires. They will not answer acceptability questions.

Interventions

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).

Also known as: AWARE OUT, single-session intervention - short

Short digital therapy program group

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.

Also known as: AWARE OUT+, single-session intervention - long

Long digital therapy program group

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").

Also known as: ABC for good mental health, Act, Belong, Commit

Mental health advice group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Oslo, 0316, Norway

Location

Related Publications (13)

• 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

  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.

  PMID: 39874601 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.

  PMID: 39443071 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.

  PMID: 31290406 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.

  PMID: 40604240 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.

  PMID: 38390026 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.

  PMID: 36372129 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.

  PMID: 27445199 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.

  PMID: 27154047 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.

  PMID: 26978655 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.

  PMID: 38606504 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.

  PMID: 35551058 BACKGROUND

• ABC for god psykisk helse. (2019, December 5). https://www.helsenorge.no/psykisk-helse/abc-for-god-psykisk-helse/

  BACKGROUND

Related Links

• Project site in Norwegian with information and updates on the project.

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Interventions

abacavir; alpha 1-Antichymotrypsin; Nicotine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Proteins; Alpha-Globulins; Serum Globulins; Globulins; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sverre U Johnson, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of clinical psychology

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2034
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Approximate start: 12.03.2027
• 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.

Locations

NO (1)