Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05509660
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.
Study:
NCT05509660
Study Brief:
Protocol Section:
NCT05509660