Psychotherapy versus waiting list for common mental disorders in Danish primary care
The Effectiveness of Psychological Interventions for Common Mental Disorders (EPIC): A Randomized Waitlist-controlled Superiority Trial.
This study will test whether psychotherapy in Danish primary care reduces symptoms of depression, anxiety, and related stress more than being on a waiting list for treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen, Central Region) |
| Trial ID | NCT06916429 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing approximately four months of psychotherapeutic treatment to a waiting-list control among clients referred to the Danish primary sector for common mental disorders. The primary outcome is symptom level on the PHQ-ADS measured about four and a half months after randomization, with additional follow-ups at about eight and 16 months. The trial also explores which client and therapy characteristics (including therapeutic alliance measured after ~5 weeks) predict treatment response and symptom change in the waitlist group. Practicing primary-sector psychologists with typical waiting times participate in delivering the interventions.
Who should consider this trial
Good fit: Adults in Denmark referred for psychotherapeutic treatment in the primary sector who read and speak Danish and agree to randomization are ideal candidates.
Not a fit: Patients judged by their therapist to be unfit for participation or who require urgent psychological or medical care are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the study could support offering timely psychotherapy in primary care to reduce depression, anxiety, and stress symptoms more effectively than delayed treatment.
How similar studies have performed: Previous randomized trials have generally shown psychotherapeutic interventions outperform waiting lists for depression and anxiety, and this trial applies that comparison in a Danish primary-care setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clients: * All clients who meet the criteria for one of the eleven referral reasons for psychotherapeutic treatment in the Danish primary sector. * Clients who read and speak proficient Danish to fill in the questionnaires. * Clients who agree to be randomized through their informed consent. Psychologists: * All practicing psychologists employed by the Danish primary sector. * Psychologists who can commit to the deadlines for beginning treatment. * Psychologists with at waiting time of approximately four months or longer. Exclusion Criteria: \- Clients considered unfit for participation or urgently needing psychological or medical help, as determined by the therapist.
Where this trial is running
Copenhagen, Central Region
- University of Copenhagen — Copenhagen, Central Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Stig Poulsen, Professor — University of Copenhagen
- Study coordinator: Celia Faye Jacobsen, PhD
- Email: celia.jacobsen@psy.ku.dk
- Phone: 45+ 22261168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.