Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study
- Conditions
- Psychological Disorder
- Interventions
- Behavioral: PUMA+Behavioral: PUMA
- Registration Number
- NCT05509660
- Lead Sponsor
- Uppsala University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Therapist-guided internet-based CBT treatment with increased therapist support 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). From mid-treatment onwards, participants will be offered increased therapist support. Therapist-guided internet-based CBT treatment with standard therapist-support PUMA 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).
- Primary Outcome Measures
Name Time Method Treatment Credibility and expectancy Questionnaire (CEQ). Baseline Credibility/expectancy. \[Feasibility and acceptability measure\]
Working Alliance Inventory - Short (WAI-S) Mid-treatment (4 weeks) The WAI-S is scale measuring the participants perceived working alliance with their therapist. \[Feasibility and acceptability measure\]
Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation Baseline Interest for intervention \[Feasibility and acceptability measure\]
Treatment completion/adherence. Post-treatment (8 weeks) Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. \[Feasibility and acceptability measure\]
Assessment completion/adherence. Post-treatment (8 weeks) Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. \[Feasibility and acceptability measure\]
Added therapist support. Mid-treatment (4 weeks) Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).
Negative Effects Questionnaire (NEQ-20) Mid-treatment (4 weeks) NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. \[Feasibility and acceptability measure\]
The Client Satisfaction Questionnaire-8 (CSQ-8) Post-treatment (8 weeks) Treatment satisfaction \[Feasibility and acceptability measure\]
Early treatment termination. Post-treatment (8 weeks) Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. \[Feasibility and acceptability measure\]
- Secondary Outcome Measures
Name Time Method World Health Organization Well-being questionnaire (WHO-5). Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months Well-being
Generalized Anxiety Disorder scale (GAD-7) Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months Change in GAD-7 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).
Insomnia Severity Index (ISI) Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months Insomnia
Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months Alcohol Use
World Health Organization Quality of Life Scale (WHOQOL-Bref). Baseline; follow-up at 12 and 24 months Quality of Life
Attitudes towards professional help (ATSPPHS) Baseline; follow-up at 12 and 24 months Attitudes towards professional help
Behavioral Activation for Depression Scale (BADS-9 Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months Behavioral Activation
Skills of Cognitive Therapy (SoCT) Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up Cognitive Therapy skills
Difficulties in Emotion-Regulation Scale (DERS-16). Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months Emotion-Regulation
Penn-State Worry Questionnaire (PSWQ) Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months Worry
Connor-Davidson Resilience Scale. Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months Resilience
Patient Health Questionnaire PHQ-9 Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months Change in PHQ-9 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).
Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM) Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months DSM-5 symptoms
Rosenberg Self-Esteem Scale (RESES) Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months Self-Esteem
Big Five Inventory-10 (BFI-10) Baseline; follow-up at 12 and 24 months Personality
Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P) Baseline; follow-up at 6, 12, and 24 months Healthcare consumption and productivity loss
Trial Locations
- Locations (1)
Uppsala University
🇸🇪Uppsala, Sweden