Psychological DisorderNCT05085756
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
A study testing Puma in people with Psychological Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disorder
- What is being tested?
- Puma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 14 Mar 2022to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9 cutoff for mild depression
- GAD-7 cutoff for mild anxiety
Who cannot join
- Suicidal ideation or plans
- Severe levels of mental ill-health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swedish Partnership in the WHO-WMH-ICS Study on National Mapping and E-health Interventions for Mental Health Issues Among University Students: Psychological Internet Treatment for Improved Mental Health
This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.
- Conditions
- Psychological Disorder
- Being tested
- Puma
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumaBehavioural
One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.
| Study group | Role | What they receive |
|---|---|---|
| Guided treatment | Active comparator | 8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision. Receives: Behavioral: Puma |
| Unguided treatment | Active comparator | 8-week transdiagnostic CBT without guidance. Receives: Behavioral: Puma |
| Waitlist | Other | 8-week transdiagnostic CBT without guidance, made available 6 months after recruitment. Receives: Behavioral: Puma |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 for depression
9 items measuring depressive symptoms
Measured: last 2 weeks
GAD-7 for anxiety
7 items measuring anxiety symptoms
Measured: last 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Mar 2022
- Primary completion30 Dec 2025
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet
- Responsible party
- Principal investigator, Anne H Berman, Uppsala University
- Investigators
- Anne H Berman, PhD, Principal investigator, Dept of Psychology, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085756
- Sponsor's protocol ID
- 2021-03599
- Status last verified
- May 2026
- First submitted
- 6 Oct 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.
Publications
Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.
PubMed 34418224Berman AH, Topooco N, Lindfors P, Bendtsen M, Lindner P, Molander O, Kraepelien M, Sundstrom C, Talebizadeh N, Engstrom K, Vlaescu G, Andersson G, Andersson C. Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial. Trials. 2024 Mar 1;25(1):158. doi: 10.1186/s13063-024-07986-1.
PubMed 38429834
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Partnership in the WHO-WMH-ICS Study on National Mapping and E-health Interventions for Mental Health Issues Among University Students: Psychological Internet Treatment for Improved Mental Health
- ClinicalTrials.gov ID
- NCT05085756
- Acronym / sponsor ID
- 2021-03599
- Conditions
- Psychological Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Oct 2021 (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.
This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided treatment | Active comparator | Behavioral: Puma8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision. |
| Unguided treatment | Active comparator | Behavioral: Puma8-week transdiagnostic CBT without guidance. |
| Waitlist | Other | Behavioral: Puma8-week transdiagnostic CBT without guidance, made available 6 months after recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PHQ-9 cutoff for mild depression
- GAD-7 cutoff for mild anxiety
Key exclusion criteria (2 listed)
- Suicidal ideation or plans
- Severe levels of mental ill-health
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 |
|---|---|---|
| PumaOne psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules. | Behavioural | Guided treatment, Unguided treatment, Waitlist |
Primary outcome
PHQ-9 for depression
Time frame: last 2 weeks
9 items measuring depressive symptoms
GAD-7 for anxiety
Time frame: last 2 weeks
7 items measuring anxiety symptoms
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 7 May 2026.
- Background: PubMed 34418224Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.
- Background: PubMed 38429834Berman AH, Topooco N, Lindfors P, Bendtsen M, Lindner P, Molander O, Kraepelien M, Sundstrom C, Talebizadeh N, Engstrom K, Vlaescu G, Andersson G, Andersson C. Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial. Trials. 2024 Mar 1;25(1):158. doi: 10.1186/s13063-024-07986-1.
- Individual participant dataSharing planned: No. This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.
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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. This study is not recruiting at the moment.
Anne H Berman, PhD principal investigator
Dept of Psychology, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puma in people with Psychological Disorder, run by Uppsala University at 1 site in Sweden.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 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 Sweden. 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?
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?
PHQ-9 for depression (time frame: last 2 weeks). 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?
On the ClinicalTrials.gov record for NCT05085756, which also lists 2 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 7 May 2026.