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Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

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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

Tracking Information
First Submitted Date  ICMJE October 6, 2021
First Posted Date  ICMJE October 20, 2021
Last Update Posted Date May 19, 2023
Actual Study Start Date  ICMJE March 14, 2022
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Psychological Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Guided treatment
    8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision.
    Intervention: Behavioral: Puma
  • Active Comparator: Unguided treatment
    8-week transdiagnostic CBT without guidance.
    Intervention: Behavioral: Puma
  • Waitlist
    8-week transdiagnostic CBT without guidance, made available 6 months after recruitment.
    Intervention: Behavioral: Puma
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2021)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne H Berman, PhD +46704245360 anne.h.berman@psyk.uu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05085756
Other Study ID Numbers  ICMJE 2021-03599
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Anne H Berman, Uppsala University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Uppsala University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Linkoeping University
  • Malmö University
  • Stockholm University
  • Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Anne H Berman, PhD Dept of Psychology, Uppsala University
PRS Account Uppsala University
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP