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

Study Overview
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Brief Summary
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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.

Official Title
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E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment

Conditions
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Psychological Disorder

Intervention / Treatment
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* Behavioral: PUMA+
* Behavioral: PUMA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapist-guided internet-based CBT treatment with increased therapist support<br>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. | Behavioral: PUMA+<br>* Transdiagnostic CBT<br>|
| Active Comparator: Therapist-guided internet-based CBT treatment with standard therapist-support<br>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). | Behavioral: PUMA<br>* Transdiagnostic CBT<br>* Other names: Transdiagnostic CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Credibility and expectancy Questionnaire (CEQ). | Credibility/expectancy. [Feasibility and acceptability measure] | Baseline | 
| Working Alliance Inventory - Short (WAI-S) | The WAI-S is scale measuring the participants perceived working alliance with their therapist. [Feasibility and acceptability measure] | Mid-treatment (4 weeks) | 
| The Client Satisfaction Questionnaire-8 (CSQ-8) | Treatment satisfaction [Feasibility and acceptability measure] | Post-treatment (8 weeks) | 
| Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation | Interest for intervention [Feasibility and acceptability measure] | Baseline | 
| Treatment completion/adherence. | Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. [Feasibility and acceptability measure] | Post-treatment (8 weeks) | 
| Assessment completion/adherence. | Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. [Feasibility and acceptability measure] | Post-treatment (8 weeks) | 
| Added therapist support. | Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8). | Mid-treatment (4 weeks) | 
| Early treatment termination. | Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. [Feasibility and acceptability measure] | Post-treatment (8 weeks) | 
| Negative Effects Questionnaire (NEQ-20) | NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. [Feasibility and acceptability measure] | Mid-treatment (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire PHQ-9 | Change in PHQ-9 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks). | Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months | 
| Generalized Anxiety Disorder scale (GAD-7) | Change in GAD-7 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks). | Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months | 
| World Health Organization Well-being questionnaire (WHO-5). | Well-being | Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Attitudes towards professional help (ATSPPHS) | Attitudes towards professional help | Baseline; follow-up at 12 and 24 months | 
| Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM) | DSM-5 symptoms | Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Insomnia Severity Index (ISI) | Insomnia | Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Behavioral Activation for Depression Scale (BADS-9 | Behavioral Activation | Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Skills of Cognitive Therapy (SoCT) | Cognitive Therapy skills | Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up | 
| World Health Organization Quality of Life Scale (WHOQOL-Bref). | Quality of Life | Baseline; follow-up at 12 and 24 months | 
| Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). | Alcohol Use | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Rosenberg Self-Esteem Scale (RESES) | Self-Esteem | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Connor-Davidson Resilience Scale. | Resilience | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Difficulties in Emotion-Regulation Scale (DERS-16). | Emotion-Regulation | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Penn-State Worry Questionnaire (PSWQ) | Worry | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | 
| Big Five Inventory-10 (BFI-10) | Personality | Baseline; follow-up at 12 and 24 months | 
| Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P) | Healthcare consumption and productivity loss | Baseline; follow-up at 6, 12, and 24 months |