Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
Sponsor
Uppsala University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05085756
Collaborator
Linkoeping University (Other), Malmö University (Other), Stockholm University (Other), Karolinska Institutet (Other)
200
1
3
33.6
6
Study Details
Study Description
Brief Summary
This study will offer 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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
:
Mar 14, 2022
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2024
Arms and Interventions
| 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.
|
| Other: 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
Primary Outcome Measures
- PHQ-9 for depression [last 2 weeks]
9 items measuring depressive symptoms
- GAD-7 for anxiety [last 2 weeks]
7 items measuring anxiety symptoms
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uppsala University | Stockholm | Sweden | 11630 |
Sponsors and Collaborators
- Uppsala University
- Linkoeping University
- Malmö University
- Stockholm University
- Karolinska Institutet
Investigators
- Principal Investigator: Anne H Berman, PhD, Dept of Psychology, Uppsala University
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Anne H Berman,
Professor,
Uppsala University
ClinicalTrials.gov Identifier:
NCT05085756
Other Study ID Numbers:
- 2021-03599
First Posted:
Oct 20, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: