Major Depression DisorderDigiTIFFNCT07346911
Digital Interventions for Relapse Prevention in Adolescence
A study testing Transdiagnostic app intervention and Transdiagnostic mastery course in people with Major Depression Disorder and ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), run by University of Oslo at 1 site in Norway.
Trial summary
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain… Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
- What is being tested?
- Transdiagnostic app intervention and Transdiagnostic mastery course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteNorway
- Study dates
- 7 Apr 2026to 1 Jun 2027
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
- Native or fluent Scandinavian language skills.
- Willingness to take part even when allocated to the non-preferred arm of the trial.
Who cannot join
- Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
- Recent completion of one of the interventions in the two interventional arms.
- no available smartphone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
University of Oslo
Oslo
Ragnhild Bø, PhD, +47 41904595, ragnhild.bo@psykologi.uio.no
About this study
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.
The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.
We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.
- Being tested
- Transdiagnostic app intervention, Transdiagnostic mastery course
- Keywords
- Transdiagnostic interventions
- Medical subject headings
- Anxiety Disorders, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic app interventionBehavioural
A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:
- Standardized self-assessment for mental health: 'Test your psychological immune system'.
- Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins).
- Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.
Transdiagnostic mastery courseBehavioural
Group-based webinar offering psychoeducation based on principles of CBT.
| Study group | Role | What they receive |
|---|---|---|
| App intervention | Experimental | A transdiagnostic, self-guided CBT app:
1. Standardized self-assessment for mental health: 'Test your psychological immune system'.
2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins).
3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives. Receives: Behavioral: Transdiagnostic app intervention |
| Group intervention | Experimental | A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions. Receives: Behavioral: Transdiagnostic mastery course |
| Assessment only | No intervention | Only assessment will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder:
- Questions 1 and/or 2 need to be endorsed as a "2" or "3"
- Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and "1", "2", or "3" in question 9).
- The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
Measured: From enrollment to the end of follow-up at 12-months.
Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached.
- Questions 1 and/or 2 need to be endorsed as a "2" or "3"
- Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and by a "1", "2", or "3" in question 9).
- The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
Measured: From enrollment to 12-months follow-up
Secondary outcomes (5)
Repetitive negative thinking (RNT-10)
Assess transdiagnostic repetitive negative thinking
Measured: At enrollment, and at 3, 6 and 12 months follow-up
Somatic complaints (SSS8)
Somatic complaints based on sum score of all items
Measured: At enrollment, and at 3, 6, and 12-months follow-up.
EPOCH Measure of Adolescent Well-Being
A 20-item validated questionnaire (4 items per domain; Engagement, Perseverance, Optimism, Connectedness, Happiness) on a 1-5 Likert scale (1=Almost Never, 5=Almost Always) resulting in domain scores, reflecting strengths in these positive psychological areas crucial for youth well-being.
Measured: At baseline, 3, 6 and 12-months follow-up.
Health related quality of life
EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions.
Measured: At baseline, 3, 6 and 12-months follow-up.
Health related quality of life - Visual Analog Scale
EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions.
Measured: At baseline, 3, 6 and 12-months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start7 Apr 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragnhild Bø, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346911
- Sponsor's protocol ID
- 870757
- Acronym
- DigiTIFF
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset underlying the results will be shared together with publications.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Interventions for Relapse Prevention in Adolescence
- ClinicalTrials.gov ID
- NCT07346911
- Acronym / sponsor ID
- DigiTIFF / 870757
- Keywords
- Transdiagnostic interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Jan 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.
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.
The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.
We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| App intervention | Experimental | Behavioral: Transdiagnostic app interventionA transdiagnostic, self-guided CBT app: 1. Standardized self-assessment for mental health: 'Test your psychological immune system'. 2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins). 3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives. |
| Group intervention | Experimental | Behavioral: Transdiagnostic mastery courseA transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions. |
| Assessment only | No intervention | –Only assessment will be conducted. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
- Native or fluent Scandinavian language skills.
- Willingness to take part even when allocated to the non-preferred arm of the trial.
Key exclusion criteria (3 listed)
- Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
- Recent completion of one of the interventions in the two interventional arms.
- no available smartphone.
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 |
|---|---|---|
| Transdiagnostic app interventionA transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components: 1. Standardized self-assessment for mental health: 'Test your psychological immune system'. 2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins). 3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives. | Behavioural | App intervention |
| Transdiagnostic mastery courseGroup-based webinar offering psychoeducation based on principles of CBT. | Behavioural | Group intervention |
Primary outcome
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
Time frame: From enrollment to the end of follow-up at 12-months.
To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder: * Questions 1 and/or 2 need to be endorsed as a "2" or "3" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
Time frame: From enrollment to 12-months follow-up
Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached. - Questions 1 and/or 2 need to be endorsed as a "2" or "3" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and by a "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
5 secondary outcomes
Repetitive negative thinking (RNT-10)
Time frame: At enrollment, and at 3, 6 and 12 months follow-up
Somatic complaints (SSS8)
Time frame: At enrollment, and at 3, 6, and 12-months follow-up.
EPOCH Measure of Adolescent Well-Being
Time frame: At baseline, 3, 6 and 12-months follow-up.
Health related quality of life
Time frame: At baseline, 3, 6 and 12-months follow-up.
Health related quality of life - Visual Analog Scale
Time frame: At baseline, 3, 6 and 12-months follow-up.
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 13 Mar 2026.
- Project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The dataset underlying the results will be shared together with publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic app intervention and Transdiagnostic mastery course in people with Major Depression Disorder and ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 Mar 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. 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?
Contact Ragnhild Bø, Ph.D. (+47 41904595, ragnhild.bo@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up. (time frame: From enrollment to the end of follow-up at 12-months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.