The Effectiveness of Psychological Interventions for Common Mental Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Psychotherapeutic treatment: The psychotherapeutic treatment will reflect the therapy practices that characterize the Danish primary sector. Treatment: Clients are referred by their GP to receive up to 12 individual psychotherapy sessions, typically of 50-60 minutes' duration. For clients with depression and anxiety as referral reason, it is possible to get a supplementary referral by the GP ensuring 12 more sessions, totaling 24 sessions of therapy. Procedure: Due to the Danish primary sector having relative freedom in method of choice, the psychologist carries out the psychotherapy according to the treatment principles they consider the most relevant, without clauses regarding specific models of therapy or manualization. The therapists register the therapeutic approaches and interventions used in each course of therapy on The Multitheoretical List of Therapeutic Interventions (MULTI-30)at the end of each treatment.

Waiting List for Psychotherapeutic Treatment: Treatment: During the waiting list period, clients will not receive any psychotherapeutic treatment for their mental health issues in the Danish primary sector. However, their general practitioner may refer them to appropriate psychiatric treatment if their mental condition worsens and requires immediate treatment. Procedure: Clients in the waiting list group will fill in questionnaires on their symptom development during the waiting period. They will complete the same set of predictor and outcome questionnaires as the psychotherapy group.

Study 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

Primary outcome measure(s)

• Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) — Measured at: Baseline, bi-weekly, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date
  The PHQ-ADS combines the PHQ-9 and the GAD-7 in to a composite measure of depression and anxiety. The PHQ-ADS sums the PHQ-9 and the GAD-7 in to a total score ranging from 0 to 48. The PHQ-ADS has demonstrated high internal reliability as well as convergent validity and con-struct validity in a large sample of primary care patients.

Trial sites (1)

More University of Copenhagen trials in Denmark