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Clinical Trials/ISRCTN10064801
ISRCTN10064801Active, not recruitingUnknown

Effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone internet-delivered or face-to-face cognitive behavioral therapy for anxiety: a randomized controlled non-inferiority trial of the finnish first-line therapies–initiative

Helsinki University Hospital0 sites948 target enrollmentStarted: September 20, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Unknown
Status
Active, not recruiting
Sponsor
Enrollment
948
Primary Endpoint
Anxiety symptoms measured by the GAD-7. The GAD-7 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time.
Study OverviewEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1.Minimum age of 16 years2.Suitable for step 1-2 treatments (guided self-help, iCBT or CBT intervention) for anxiety in the first assessment3.GAD-7 =5

Exclusion Criteria

  • •General exclusion criteria for step 1-2 treatments (i.e. recommended stepping up):
  • •Serious suicidal thoughts, plans or any self-harming act or suicidal attempt within the past 2 months
  • •Ongoing other psychological treatment for depression and/or anxiety
  • •Cognitive impairment
  • •Inability to speak, read and write Finnish
  • •Currently symptomatic psychotic illness or bipolar disorder
  • •Drug or alcohol dependence

Outcomes

Primary Outcomes

Anxiety symptoms measured by the GAD-7. The GAD-7 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Helsinki University Hospital

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