Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study

NCT ID: NCT05509660

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2023-12-31

Brief Summary

This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).

The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.

Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.

Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.

Conditions

Psychological Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapist-guided internet-based CBT treatment with increased therapist support

Intervention/treatment: Behavioral: 'PUMA+'

8-week transdiagnostic CBT with therapist-support. 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 (acceptance; maintenance of skills learned). From mid-treatment onwards, participants will be offered increased therapist support.

Group Type: EXPERIMENTAL

PUMA+

Intervention Type: BEHAVIORAL

Transdiagnostic CBT

Therapist-guided internet-based CBT treatment with standard therapist-support

Intervention/treatment: Behavioral: 'PUMA' Intervention/treatment: Behavioral: 'PUMA'

8-week transdiagnostic CBT with therapist support. 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 (acceptance; maintenance of skills learned).

Group Type: ACTIVE_COMPARATOR

PUMA

Intervention Type: BEHAVIORAL

Transdiagnostic CBT

Interventions

PUMA+

Transdiagnostic CBT

Intervention Type: BEHAVIORAL

PUMA

Transdiagnostic CBT

Intervention Type: BEHAVIORAL

Other Intervention Names

Transdiagnostic CBT

Eligibility Criteria

Inclusion Criteria

• College/university student at institution of higher education in Sweden
• Score 5-19 on the PHQ-9, and/or
• Score ≥5 on the GAD-7
• Completed baseline assessment

Exclusion Criteria

• Pharmacotherapy for mental health issue during the past 3 weeks)
• Concurrent psychological treatment during the past 3 weeks
• Mild levels of mental ill-health (under cut-off for primary outcome measures)
• Severe levels of mental ill-health
• Suicidal ideation or plans

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Malmö University

OTHER

Sponsor Role: collaborator

Stockholm University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne H Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 34418224 (View on PubMed)

Other Identifiers

2021-03599P

Identifier Type: -

Identifier Source: org_study_id