Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: PUMA+
Transdiagnostic CBT
|
| Active Comparator: 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). |
Behavioral: PUMA
Transdiagnostic CBT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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]
- The Client Satisfaction Questionnaire-8 (CSQ-8) [Post-treatment (8 weeks)]
Treatment satisfaction [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).
- 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]
- 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]
Secondary Outcome Measures
- 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).
- 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).
- 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
- Attitudes towards professional help (ATSPPHS) [Baseline; follow-up at 12 and 24 months]
Attitudes towards professional help
- 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
- Insomnia Severity Index (ISI) [Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months]
Insomnia
- 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
- World Health Organization Quality of Life Scale (WHOQOL-Bref). [Baseline; follow-up at 12 and 24 months]
Quality of Life
- Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). [Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months]
Alcohol Use
- Rosenberg Self-Esteem Scale (RESES) [Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months]
Self-Esteem
- Connor-Davidson Resilience Scale. [Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months]
Resilience
- 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
- 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
Eligibility Criteria
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
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
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 2021-03599P