NCT05085756

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Mar 2022Jun 2027

First Submitted

Initial submission to the registry

October 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3.8 years

First QC Date

October 6, 2021

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • PHQ-9 for depression

    9 items measuring depressive symptoms

    last 2 weeks

  • GAD-7 for anxiety

    7 items measuring anxiety symptoms

    last 2 weeks

Study Arms (3)

Guided treatment

ACTIVE COMPARATOR

8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision.

Behavioral: Puma

Unguided treatment

ACTIVE COMPARATOR

8-week transdiagnostic CBT without guidance.

Behavioral: Puma

Waitlist

OTHER

8-week transdiagnostic CBT without guidance, made available 6 months after recruitment.

Behavioral: Puma

Interventions

PumaBEHAVIORAL

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.

Guided treatmentUnguided treatmentWaitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PHQ-9 cutoff for mild depression
  • GAD-7 cutoff for mild anxiety

You may not qualify if:

  • Suicidal ideation or plans
  • Severe levels of mental ill-health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 75105, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 34418224BACKGROUND
  • Berman 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.

    PMID: 38429834BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Interventions

bbc3 protein, zebrafish

Study Officials

  • Anne H Berman, PhD

    Dept of Psychology, Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 20, 2021

Study Start

March 14, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

June 30, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.

Locations