The Effectiveness of Psychological Interventions for Common Mental Disorders

NCT06916429 | Recruiting

• 1 other identifier: IP-EC-19012024-1
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Mental Disorders and/or Stress Related Symptoms

Keywords

psychotherapy; common mental disorders; depression; anxiety; randomized controlled trial

Outcome Measures

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.

  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

Secondary Outcomes (5)

• Sheehan Disability Scale (SDS)

  Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date

• The WHO-5 well-being index (WHO-5)

  Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date

• Cohen's Perceived Stress Scale (PSS)

  Measured at: Baseline, four and a half months after randomization date, eight and a half months after randomization date, 12 months after randomization date

• The Client Satisfaction Questionnaire (CSQ)

  Measured at: Baseline, four and a half months after randomization date.

• The Negative Effects Questionnaire (NEQ)

  Measured at: Baseline and four and a half months after randomization date.

Study Arms (2)

Wailist Control Group

OTHER

Description: Clients in the waitlist control group will be placed on a waiting list for psychotherapy with treatment starting approximately four and a half months after the date of randomization. Objective: To serve as a control group to the intervention group receiving psychotherapy and to investigate distinct symptom trajectories during the waiting period.

Other: Waiting List for Psychotherapeutic Treatment

Psychotherapy Intervention Group

EXPERIMENTAL

Description: Clients in the psychotherapy intervention group will receive psychotherapeutic treatment with treatment starting within 14 days of the randomization date. Objective: To determine the effectiveness of psychotherapy in the Danish primary sector over approximately a four-month period.

Other: Psychotherapeutic treatment

Interventions

Psychotherapeutic treatment OTHER

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.

Also known as: psychological treatment, psychotherapy, psychological intervention

Psychotherapy Intervention Group

Waiting List for Psychotherapeutic Treatment OTHER

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.

Also known as: waitlist, waiting list control group, waitlist for therapy

Wailist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Clients considered unfit for participation or urgently needing psychological or medical help, as determined by the therapist.

Sponsors & Collaborators

• University of Copenhagen: lead
• the Danish Psychological Association: collaborator
• The Danish Regions: Foundation for Medical Research: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, Central Region, 1452, Denmark

RECRUITING

Related Links

• The official website for the EPIC trial

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Psychotherapy; Psychosocial Intervention; Waiting Lists; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Stig Poulsen, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Ole Karkov Østergård, Associate Professor

  Aalborg University

  STUDY CHAIR

• Carsten Hjorthøj, Associate Professor

  University of Copenhagen

  STUDY CHAIR

• Celia Faye Jacobsen, PhD

  University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Celia Faye Jacobsen, PhD

CONTACT

45+ 22261168; celia.jacobsen@psy.ku.dk

Stig Poulsen, Professor

CONTACT

45 + 28593543; stig.poulsen@psy.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)