DepressionNCT07499219
Preliminary Testing and Development of a Short Digital Intervention for Patients on Waiting Lists for Psychological Treatment
A study testing Digital therapy program (short), Digital therapy program (long) and Mental health advice in people with Depression and Anxiety, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Digital therapy program (short), Digital therapy program (long) and Mental health advice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 24 Mar 2026to Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No criteria excluding participants who meet the above mentioned inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- To evaluate the feasibility and acceptability of the study procedures and the digital single-session intervention.
- To gather quantitative and qualitative feedback on the intervention to inform further development.
- To collect preliminary data to refine the analysis plan for a main trial.
Read more
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.
Read the 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:
- 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.
- Conditions
- Depression, Anxiety
- Being tested
- Digital therapy program (short), Digital therapy program (long), Mental health advice
- Keywords
- depression, anxiety, single-session intervention, digital mental health intervention, digital therapy, mental health, pilot feasibility trial
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital therapy program (short)Other
Also called AWARE OUT, single-session intervention - 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).
Digital therapy program (long)Other
Also called AWARE OUT+, single-session intervention - 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.
Mental health adviceOther
Also called ABC for good mental health, Act, Belong, Commit
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").
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
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.
Measured: Two weeks and five weeks after enrollment controlled by baseline at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start24 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sverre Urnes Johnson, University of Oslo
- Investigators
- Sverre U Johnson, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499219
- Sponsor's protocol ID
- PILOTSIO945368
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No IPD will be shared outside of the research team involved with this study.
Publications
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
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.
PubMed 39874601Ramos 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.
PubMed 39443071Schleider 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.
PubMed 31290406Smith 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.
PubMed 40604240Lipschitz 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.
PubMed 38390026van 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.
PubMed 36372129Steinert 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.
PubMed 27445199Thielen 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.
PubMed 27154047Eldridge 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.
PubMed 26978655Ke 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.
PubMed 38606504Philippe 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.
PubMed 35551058ABC for god psykisk helse. (2019, December 5). https://www.helsenorge.no/psykisk-helse/abc-for-god-psykisk-helse/
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Web-based Transdiagnostic Single Session Intervention for Patients on Waiting Lists for Psychological Treatment: a Randomized Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07499219
- Acronym / sponsor ID
- PILOTSIO945368
- Conditions
- Depression, Anxiety
- Keywords
- depression, anxiety, single-session intervention, digital mental health intervention, digital therapy, mental health, pilot feasibility trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the feasibility and acceptability of the study procedures and the digital single-session intervention.
- To gather quantitative and qualitative feedback on the intervention to inform further development.
- 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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Short digital therapy program group | Experimental | Other: Digital therapy program (short)Participants complete the short digital therapy program (30-40 minutes) and answer questions about acceptability, feedback and interaction with other therapy. |
| Long digital therapy program group | Experimental | Other: Digital therapy program (long)Participants complete the long digital therapy program (45-55 minutes) and answer questions about acceptability, feedback and interaction with other therapy. |
| Mental health advice group | Placebo comparator | Other: Mental health adviceParticipants 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. |
| Questionnaire group | No intervention | –Participants do not receive any intervention materials and only complete mental health questionnaires. They will not answer acceptability questions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- No criteria excluding participants who meet the above mentioned inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapy program (short)Also: AWARE OUT, single-session intervention - shortThis 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 | Short digital therapy program group |
| Digital therapy program (long)Also: AWARE OUT+, single-session intervention - longThis 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 | Long digital therapy program group |
| Mental health adviceAlso: ABC for good mental health, Act, Belong, CommitABC 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 | Mental health advice group |
Primary outcome
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
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
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
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
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
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
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.
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
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- BackgroundBorkovec, 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: PubMed 39874601Schleider 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.
- Background: PubMed 39443071Ramos 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.
- Background: PubMed 31290406Schleider 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.
- Background: PubMed 40604240Smith 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.
- Background: PubMed 38390026Lipschitz 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.
- Background: PubMed 36372129van 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.
- Background: PubMed 27445199Steinert 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.
- Background: PubMed 27154047Thielen 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.
- Background: PubMed 26978655Eldridge 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.
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- Background: PubMed 35551058Philippe 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.
- Project site in Norwegian with information and updates on the project.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. No IPD will be shared outside of the research team involved with this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sverre U Johnson, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapy program (short), Digital therapy program (long) and Mental health advice in people with Depression and Anxiety, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07499219, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.