Clinical trial NCT05509660: Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study
Official title: E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Disorder
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Malmö University
name: Stockholm University
name: Karolinska Institutet
First posted: 2022-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Treatment Credibility and expectancy Questionnaire (CEQ).
timeFrame: Baseline
measure: Working Alliance Inventory - Short (WAI-S)
timeFrame: Mid-treatment (4 weeks)
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-treatment (8 weeks)
measure: Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation
timeFrame: Baseline
measure: Treatment completion/adherence.
timeFrame: Post-treatment (8 weeks)
measure: Assessment completion/adherence.
timeFrame: Post-treatment (8 weeks)
measure: Added therapist support.
timeFrame: Mid-treatment (4 weeks)
measure: Early treatment termination.
timeFrame: Post-treatment (8 weeks)
measure: Negative Effects Questionnaire (NEQ-20)
timeFrame: Mid-treatment (4 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire PHQ-9
timeFrame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
measure: Generalized Anxiety Disorder scale (GAD-7)
timeFrame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
measure: World Health Organization Well-being questionnaire (WHO-5).
timeFrame: Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Attitudes towards professional help (ATSPPHS)
timeFrame: Baseline; follow-up at 12 and 24 months
measure: Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)
timeFrame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Behavioral Activation for Depression Scale (BADS-9
timeFrame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Skills of Cognitive Therapy (SoCT)
timeFrame: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
measure: World Health Organization Quality of Life Scale (WHOQOL-Bref).
timeFrame: Baseline; follow-up at 12 and 24 months
measure: Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
timeFrame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Rosenberg Self-Esteem Scale (RESES)
timeFrame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Connor-Davidson Resilience Scale.
timeFrame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Difficulties in Emotion-Regulation Scale (DERS-16).
timeFrame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Penn-State Worry Questionnaire (PSWQ)
timeFrame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
measure: Big Five Inventory-10 (BFI-10)
timeFrame: Baseline; follow-up at 12 and 24 months
measure: Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)
timeFrame: Baseline; follow-up at 6, 12, and 24 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.