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Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

Primary Purpose

Psychological Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Puma
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Guided treatment

Unguided treatment

Waitlist

Arm Description

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

8-week transdiagnostic CBT without guidance.

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

Outcomes

Primary Outcome Measures

PHQ-9 for depression
9 items measuring depressive symptoms
GAD-7 for anxiety
7 items measuring anxiety symptoms

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
May 17, 2023
Sponsor
Uppsala University
Collaborators
Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05085756
Brief Title
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Linkoeping University, Malmö University, Stockholm University, Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guided treatment
Arm Type
Active Comparator
Arm Description
8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision.
Arm Title
Unguided treatment
Arm Type
Active Comparator
Arm Description
8-week transdiagnostic CBT without guidance.
Arm Title
Waitlist
Arm Type
Other
Arm Description
8-week transdiagnostic CBT without guidance, made available 6 months after recruitment.
Intervention Type
Behavioral
Intervention Name(s)
Puma
Intervention Description
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.
Primary Outcome Measure Information:
Title
PHQ-9 for depression
Description
9 items measuring depressive symptoms
Time Frame
last 2 weeks
Title
GAD-7 for anxiety
Description
7 items measuring anxiety symptoms
Time Frame
last 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne H Berman, PhD
Phone
+46704245360
Email
anne.h.berman@psyk.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Dept of Psychology, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Stockholm
ZIP/Postal Code
11630
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Phone
+46704245360
Email
anne.h.berman@psyk.uu.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.
Citations:
PubMed Identifier
34418224
Citation
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.
Results Reference
background

Learn more about this trial

Transdiagnostic Internet Intervention to Improve Mental Health Among University Students

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