Psychological DisorderNCT05509660
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study
A study testing PUMA+ and PUMA in people with Psychological Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. 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+ and PUMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 6 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- College/university student at institution of higher education in Sweden
- Score 5-19 on the PHQ-9, and/or
- Score ≥5 on the GAD-7
- Completed baseline assessment
Who cannot join
- Pharmacotherapy for mental health issue during the past 3 weeks)
- Concurrent psychological treatment during the past 3 weeks
- Mild levels of mental ill-health (under cut-off for primary outcome measures)
- Severe levels of mental ill-health
- Suicidal ideation or plans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment
This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).
The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.
Read more
Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.
Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.
- Conditions
- Psychological Disorder
- Being tested
- PUMA+, 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.
PUMA+Behavioural
Transdiagnostic CBT
PUMABehavioural
Also called Transdiagnostic CBT
Transdiagnostic CBT
| Study group | Role | What they receive |
|---|---|---|
| Therapist-guided internet-based CBT treatment with increased therapist support | Experimental | Intervention/treatment: Behavioral: 'PUMA+'
8-week transdiagnostic CBT with therapist-support. 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 (acceptance; maintenance of skills learned). From mid-treatment onwards, participants will be offered increased therapist support. Receives: Behavioral: PUMA+ |
| Therapist-guided internet-based CBT treatment with standard therapist-support | Active comparator | Intervention/treatment: Behavioral: 'PUMA' Intervention/treatment: Behavioral: 'PUMA'
8-week transdiagnostic CBT with therapist support. 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 (acceptance; maintenance of skills learned). Receives: Behavioral: PUMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Credibility and expectancy Questionnaire (CEQ).
Credibility/expectancy. [Feasibility and acceptability measure]
Measured: Baseline
Working Alliance Inventory - Short (WAI-S)
The WAI-S is scale measuring the participants perceived working alliance with their therapist. [Feasibility and acceptability measure]
Measured: Mid-treatment (4 weeks)
The Client Satisfaction Questionnaire-8 (CSQ-8)
Treatment satisfaction [Feasibility and acceptability measure]
Measured: Post-treatment (8 weeks)
Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation
Interest for intervention [Feasibility and acceptability measure]
Measured: Baseline
Treatment completion/adherence.
Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. [Feasibility and acceptability measure]
Measured: Post-treatment (8 weeks)
Assessment completion/adherence.
Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. [Feasibility and acceptability measure]
Measured: Post-treatment (8 weeks)
Added therapist support.
Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).
Measured: Mid-treatment (4 weeks)
Early treatment termination.
Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. [Feasibility and acceptability measure]
Measured: Post-treatment (8 weeks)
Negative Effects Questionnaire (NEQ-20)
NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. [Feasibility and acceptability measure]
Measured: Mid-treatment (4 weeks)
Secondary outcomes (16)
Patient Health Questionnaire PHQ-9
Change in PHQ-9 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).
Measured: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
Generalized Anxiety Disorder scale (GAD-7)
Change in GAD-7 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).
Measured: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
World Health Organization Well-being questionnaire (WHO-5).
Well-being
Measured: Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Attitudes towards professional help (ATSPPHS)
Attitudes towards professional help
Measured: Baseline; follow-up at 12 and 24 months
Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)
DSM-5 symptoms
Measured: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Insomnia Severity Index (ISI)
Insomnia
Measured: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Behavioral Activation for Depression Scale (BADS-9
Behavioral Activation
Measured: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Skills of Cognitive Therapy (SoCT)
Cognitive Therapy skills
Measured: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
World Health Organization Quality of Life Scale (WHOQOL-Bref).
Quality of Life
Measured: Baseline; follow-up at 12 and 24 months
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
Alcohol Use
Measured: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Rosenberg Self-Esteem Scale (RESES)
Self-Esteem
Measured: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Connor-Davidson Resilience Scale.
Resilience
Measured: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Difficulties in Emotion-Regulation Scale (DERS-16).
Emotion-Regulation
Measured: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Penn-State Worry Questionnaire (PSWQ)
Worry
Measured: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Big Five Inventory-10 (BFI-10)
Personality
Measured: Baseline; follow-up at 12 and 24 months
Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)
Healthcare consumption and productivity loss
Measured: Baseline; follow-up at 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start6 Oct 2021
- Primary completion6 Jan 2022
- Study completion31 Dec 2023
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Anne H Berman, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509660
- Sponsor's protocol ID
- 2021-03599P
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 34418224Topooco N, Lindner P, Andersson C, Lindfors P, Molander O, Kraepelien M, Sundstrom C, Vlaescu G, Andersson G, Bendtsen M, Berman AH. Personalized Transdiagnostic Cognitive Behavior Therapy With Midtreatment Stepped Care to Improve Mental Health Among University Students in Sweden: Feasibility Study for a Randomized Controlled Trial. JMIR Form Res. 2026 Jan 15;10:e68698. doi: 10.2196/68698.
PubMed 41538789
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment
- ClinicalTrials.gov ID
- NCT05509660
- Acronym / sponsor ID
- 2021-03599P
- Conditions
- Psychological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Aug 2022 (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 comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).
The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.
Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.
Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapist-guided internet-based CBT treatment with increased therapist support | Experimental | Behavioral: PUMA+Intervention/treatment: Behavioral: 'PUMA+' 8-week transdiagnostic CBT with therapist-support. 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 (acceptance; maintenance of skills learned). From mid-treatment onwards, participants will be offered increased therapist support. |
| Therapist-guided internet-based CBT treatment with standard therapist-support | Active comparator | Behavioral: PUMAIntervention/treatment: Behavioral: 'PUMA' Intervention/treatment: Behavioral: 'PUMA' 8-week transdiagnostic CBT with therapist support. 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 (acceptance; maintenance of skills learned). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- College/university student at institution of higher education in Sweden
- Score 5-19 on the PHQ-9, and/or
- Score ≥5 on the GAD-7
- Completed baseline assessment
Key exclusion criteria (5 listed)
- Pharmacotherapy for mental health issue during the past 3 weeks)
- Concurrent psychological treatment during the past 3 weeks
- Mild levels of mental ill-health (under cut-off for primary outcome measures)
- Severe levels of mental ill-health
- Suicidal ideation or plans
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 |
|---|---|---|
| PUMA+Transdiagnostic CBT | Behavioural | Therapist-guided internet-based CBT treatment with increased therapist support |
| PUMAAlso: Transdiagnostic CBTTransdiagnostic CBT | Behavioural | Therapist-guided internet-based CBT treatment with standard therapist-support |
Primary outcome
Treatment Credibility and expectancy Questionnaire (CEQ).
Time frame: Baseline
Credibility/expectancy. [Feasibility and acceptability measure]
Working Alliance Inventory - Short (WAI-S)
Time frame: Mid-treatment (4 weeks)
The WAI-S is scale measuring the participants perceived working alliance with their therapist. [Feasibility and acceptability measure]
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Post-treatment (8 weeks)
Treatment satisfaction [Feasibility and acceptability measure]
Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation
Time frame: Baseline
Interest for intervention [Feasibility and acceptability measure]
Treatment completion/adherence.
Time frame: Post-treatment (8 weeks)
Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. [Feasibility and acceptability measure]
Assessment completion/adherence.
Time frame: Post-treatment (8 weeks)
Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. [Feasibility and acceptability measure]
Added therapist support.
Time frame: Mid-treatment (4 weeks)
Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).
Early treatment termination.
Time frame: Post-treatment (8 weeks)
Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. [Feasibility and acceptability measure]
Negative Effects Questionnaire (NEQ-20)
Time frame: Mid-treatment (4 weeks)
NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. [Feasibility and acceptability measure]
16 secondary outcomes
Patient Health Questionnaire PHQ-9
Time frame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
World Health Organization Well-being questionnaire (WHO-5).
Time frame: Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Attitudes towards professional help (ATSPPHS)
Time frame: Baseline; follow-up at 12 and 24 months
Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)
Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Insomnia Severity Index (ISI)
Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Behavioral Activation for Depression Scale (BADS-9
Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Skills of Cognitive Therapy (SoCT)
Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
World Health Organization Quality of Life Scale (WHOQOL-Bref).
Time frame: Baseline; follow-up at 12 and 24 months
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Rosenberg Self-Esteem Scale (RESES)
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Connor-Davidson Resilience Scale.
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Difficulties in Emotion-Regulation Scale (DERS-16).
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Penn-State Worry Questionnaire (PSWQ)
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Big Five Inventory-10 (BFI-10)
Time frame: Baseline; follow-up at 12 and 24 months
Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)
Time frame: Baseline; follow-up at 6, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
- Derived from this study: PubMed 41538789Topooco N, Lindner P, Andersson C, Lindfors P, Molander O, Kraepelien M, Sundstrom C, Vlaescu G, Andersson G, Bendtsen M, Berman AH. Personalized Transdiagnostic Cognitive Behavior Therapy With Midtreatment Stepped Care to Improve Mental Health Among University Students in Sweden: Feasibility Study for a Randomized Controlled Trial. JMIR Form Res. 2026 Jan 15;10:e68698. doi: 10.2196/68698.
- Individual participant dataSharing planned: No. 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
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+ and 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Credibility and expectancy Questionnaire (CEQ). (time frame: Baseline). The study lists 9 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 NCT05509660, 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 15 Oct 2024.