The Effectiveness of Psychological Interventions for Common Mental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Copenhagen
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
All practicing psychologists employed by the Danish primary sector.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psychotherapeutic treatment
Other interventionThe 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
Other interventionTreatment: 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.
Treatment groups
308 Participants
are divided into 2 treatment groupsGroup A: Wailist Control GroupOther 1 intervention
Group B: Psychotherapy Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)
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.
Time frame
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 dateSecondary outcomes
1
Sheehan Disability Scale (SDS)
The SDS is a three-item rating scale that assesses functioning in relation to three domains: work and/or education, social relationships, and family life. The client rates the extent to which a given domain has been impaired by psychological symptoms within the last month, on a scale from 0 ("not at all impaired") to 10 ("very severely impaired").
Time frame
Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date2
The WHO-5 well-being index (WHO-5)
The WHO-5 is a five-item rating scale on psychological wellbeing. Each item relates to wellbeing within the past two weeks and is rated on a scale from 0 ("none of the time") to 5 ("all of the time"). The total raw score is multiplied by four to compute a percentage scale from 0 (absence of wellbeing) to 100 (maximal wellbeing).
Time frame
Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date3
Cohen's Perceived Stress Scale (PSS)
The PSS is a ten-item questionnaire assessing the client's experience of stress within the last month. The items are rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"), with a sum score ranging from 0-40.
Time frame
Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date4
The Client Satisfaction Questionnaire (CSQ)
The CSQ is an eight-item questionnaire assessing the client's satisfaction with the therapy. The items are rated on a four-point Likert scale ranging from one to four, with a sum score ranging from 8-32.
Time frame
Measured at: Baseline, four and a half months after randomization date.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
the Danish Psychological Association
Collaborator
The Danish Regions: Foundation for Medical Research
Collaborator
Source ClinicalTrials.gov