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Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085756
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : May 19, 2023
Sponsor:
Collaborators:
Linkoeping University
Malmö University
Stockholm University
Karolinska Institutet
Information provided by (Responsible Party):
Anne H Berman, Uppsala University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psychological Disorder Behavioral: Puma Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Guided treatment
8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision.
 Behavioral: Puma
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.
Active Comparator: Unguided treatment
8-week transdiagnostic CBT without guidance.
 Behavioral: Puma
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.
Waitlist
8-week transdiagnostic CBT without guidance, made available 6 months after recruitment.
 Behavioral: Puma
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.


Outcome Measures
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Primary Outcome Measures :
  1. PHQ-9 for depression [ Time Frame: last 2 weeks ]
    9 items measuring depressive symptoms

  2. GAD-7 for anxiety [ Time Frame: last 2 weeks ]
    7 items measuring anxiety symptoms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicidal ideation or plans
  • Severe levels of mental ill-health
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085756


Contacts
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Contact: Anne H Berman, PhD +46704245360 anne.h.berman@psyk.uu.se

Locations
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Sweden
Uppsala University Recruiting
Stockholm, Sweden, 11630
Contact: Anne H Berman, PhD    +46704245360    anne.h.berman@psyk.uu.se   
Sponsors and Collaborators
Uppsala University
Linkoeping University
Malmö University
Stockholm University
Karolinska Institutet
Investigators
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Principal Investigator: Anne H Berman, PhD Dept of Psychology, Uppsala University
More Information
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Publications:

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Responsible Party: Anne H Berman, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT05085756    
Other Study ID Numbers: 2021-03599
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders