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

Psychological Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05509660
• Other study ID #: 2021-03599P
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychological Disorder

Intervention

Behavioral:
• PUMA+
Transdiagnostic CBT
• PUMA
Transdiagnostic CBT

Locations

Country	Name	City	State
Sweden	Uppsala University	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet, Linkoeping University, Malmö University, Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Credibility and expectancy Questionnaire (CEQ).	Credibility/expectancy. [Feasibility and acceptability measure]	Baseline
Primary	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)
Primary	The Client Satisfaction Questionnaire-8 (CSQ-8)	Treatment satisfaction [Feasibility and acceptability measure]	Post-treatment (8 weeks)
Primary	Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation	Interest for intervention [Feasibility and acceptability measure]	Baseline
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	Attitudes towards professional help (ATSPPHS)	Attitudes towards professional help	Baseline; follow-up at 12 and 24 months
Secondary	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
Secondary	Insomnia Severity Index (ISI)	Insomnia	Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	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
Secondary	Skills of Cognitive Therapy (SoCT)	Cognitive Therapy skills	Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
Secondary	World Health Organization Quality of Life Scale (WHOQOL-Bref).	Quality of Life	Baseline; follow-up at 12 and 24 months
Secondary	Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).	Alcohol Use	Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	Rosenberg Self-Esteem Scale (RESES)	Self-Esteem	Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	Connor-Davidson Resilience Scale.	Resilience	Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	Difficulties in Emotion-Regulation Scale (DERS-16).	Emotion-Regulation	Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	Penn-State Worry Questionnaire (PSWQ)	Worry	Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Secondary	Big Five Inventory-10 (BFI-10)	Personality	Baseline; follow-up at 12 and 24 months
Secondary	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