Uppsala University
Uppsala, 75105, Sweden
NCT Number: NCT05509660
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Uppsala, 75105, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transdiagnostic CBT
Transdiagnostic CBT
Other names: Transdiagnostic CBT
Time frame: Baseline
Credibility/expectancy. [Feasibility and acceptability measure]
Time frame: Mid-treatment (4 weeks)
The WAI-S is scale measuring the participants perceived working alliance with their therapist. [Feasibility and acceptability measure]
Time frame: Post-treatment (8 weeks)
Treatment satisfaction [Feasibility and acceptability measure]
Time frame: Baseline
Interest for intervention [Feasibility and acceptability measure]
Time frame: Post-treatment (8 weeks)
Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. [Feasibility and acceptability measure]
Time frame: Post-treatment (8 weeks)
Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. [Feasibility and acceptability measure]
Time frame: 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).
Time frame: 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]
Time frame: 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]
Time frame: 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).
Time frame: 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).
Time frame: Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Well-being
Time frame: Baseline; follow-up at 12 and 24 months
Attitudes towards professional help
Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
DSM-5 symptoms
Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Insomnia
Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Behavioral Activation
Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
Cognitive Therapy skills
Time frame: Baseline; follow-up at 12 and 24 months
Quality of Life
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Alcohol Use
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Self-Esteem
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Resilience
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Emotion-Regulation
Time frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Worry
Time frame: Baseline; follow-up at 12 and 24 months
Personality
Time frame: Baseline; follow-up at 6, 12, and 24 months
Healthcare consumption and productivity loss
Uppsala University
Other
E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment
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