NCT06916429 The Effectiveness of Psychological Interventions for Common Mental Disorders
| NCT ID | NCT06916429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Copenhagen |
| Condition | Common Mental Disorders and/or Stress Related Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 308 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 308 participants in total. It began in 2025-04-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary aim of "the Effectiveness of Psychological Interventions for Common mental disorders" (EPIC) randomized controlled trial is to investigate whether a significantly larger symptom improvement is observed after approximately four months of psychotherapeutic treatment in the Danish primary sector compared to in a waiting list control group. The secondary aim of the study is to identify specific client and therapy characteristics that may predict the effectiveness of the therapy or the symptom development in the waiting list control group. The main hypothesis of the EPIC trial is: 1\) Four and a half months after randomization, we will find a significantly lower level of symptoms on the primary outcome measure (PHQ-ADS) among clients who receive psychotherapy, compared to clients in the waiting list control group. In addition, we hypothesize to find significantly better outcomes in the psychotherapy group on all secondary outcome measures, four and a half months after randomization. Researchers will compare: * Psychotherapy starting within 14 days after the randomization date with * Placement on a waiting list for psychotherapy with treatment starting approximately four and a half months after the randomization date to investigate whether a larger symptom improvement is observed in the group receiving psychotherapy compared to the waiting list control group. Participants will: * Be referred by their general practitioner (GP) for publicly subsidized psychotherapy treatment in the primary care sector in Denmark, based on one of 11 referral reasons. * Complete the baseline questionnaire containing background information, the primary and secondary outcome measures, and predictor questionnaires, and subsequently be randomized to either psychotherapy beginning within two weeks or a waiting list control group. * Receive a brief symptom questionnaire (the PHQ-ADS) every other week after the randomization date via an SMS-based solution provided by REDCap. * Complete the primary and secondary outcome measures approximately four and a half, eight and a half, and 16 and a half months after the randomization date.
Eligibility 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.
Contact & Investigator
Stig Poulsen, Professor
PRINCIPAL INVESTIGATOR
University of Copenhagen
Frequently Asked Questions
Who can join the NCT06916429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Common Mental Disorders and/or Stress Related Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06916429 currently recruiting?
Yes, NCT06916429 is actively recruiting participants. Contact the research team at celia.jacobsen@psy.ku.dk for enrollment information.
Where is the NCT06916429 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06916429 clinical trial?
NCT06916429 is sponsored by University of Copenhagen. The principal investigator is Stig Poulsen, Professor at University of Copenhagen. The trial plans to enroll 308 participants.