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

Uppsala University

Status: Completed

Conditions: Psychological Disorder

Treatments: Behavioral: PUMA; Behavioral: PUMA+

Study type: Interventional

Funder types: Other

Identifiers

NCT05509660

2021-03599P

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: PUMA+

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

Active Comparator group

Description:

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).

Treatment:

Behavioral: PUMA