DISTRESS Trial Functional Disorders - the DISTRESS Trial

NCT06025617 | Active Not Recruiting

• 1 other identifier: 147304
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a patient has an FSD or the symptoms were caused by another physical illness or mental disorder. As a novelty in this project, Internal Medicine consultants examine the patients for FSD, after having received training in diagnosing FSD by FSD experts. By performing diagnostic evaluation for physical diseases and FSD simultaneously, the investigators believe that the new clinic shall be able to accelerate the establishment of a final diagnosis for these patients who would otherwise likely undergo a protracted diagnostic course involving sequential evaluations at various specialty clinics. The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.

Conditions

Bodily Distress Syndrome; Functional Somatic Disorder

Keywords

Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Somatoform Disorders

Outcome Measures

Primary Outcomes (2)

• Healthcare services utilization (i.e. direct costs)

  Comparison of healthcare services utilization (of secondary and tertiary sector care) by the intervention group, compared to the control group. Data shall be drawn from Danish national and regional healthcare service registers.

  12 months prior to randomization and 12 months' follow-up

• Cost-effectiveness analysis (CEA) (direct and indirect costs)

  Cost-effectiveness analysis (CEA), comparing the intervention and the control group from both a healthcare (direct costs) and a societal perspective (indirect costs) combining data on incremental costs and incremental effects; adjusted for differences in mean utility score and mean costs at baseline (1 year prior to randomization).

  12 months prior to randomization and 12 months' follow-up

Secondary Outcomes (4)

• Public expenses associated with occupational status and social benefits (i.e. indirect costs)

  12 months prior to randomization and 12 months' follow-up

• Effectiveness: Health-related quality of life (via the the Short Form 36 Total Score)

  Baseline, 3- and 12-months' follow-up

• Effectiveness: Perceived physical health

  Baseline, 3- and 12-months' follow-up

• Effectiveness (via Patient-reported Clinical Global Improvement)

  At 3- and 12-months' follow-up

Other Outcomes (3)

• Symptom level comparison

  At 3- and 12 months follow-up

• Health anxiety

  At 3- and 12 months follow-up

• Overall physical health

  At 3- and 12 months follow-up

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm.

Other: Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders

Control arm

ACTIVE COMPARATOR

Patients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm.

Other: Diagnostic as usual

Interventions

Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders OTHER

The intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient.

Intervention arm

Diagnostic as usual OTHER

"Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.

Control arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being referred to the clinic by their GP due to symptoms consistent with a possible diagnosis of moderate or severe FSD.
• Symptoms having been present for at least 6 months and no more than 3 years.
• Having undergone at least 2 diagnostic evaluations (e.g. imaging studies or specialist evaluations) at physical specialty clinics or hospitals in the past year.
• Age 18-60.
• Being of ethnic western cultural upbringing.
• Understands and speaks Danish fluently.

You may not qualify if:

• Having another severe chronic disease which explains the reduced level of functioning.
• Having been previously referred to or evaluated for FSD at this or another clinic specializing in functional disorders.
• Previous diagnosis of FSD.
• Alcohol or other substance-dependency or -abuse.
• Emergent psychiatric illness or emergent elevated risk of harm to self or others requiring psychiatric evaluation for possible need of acute or sub-acute psychiatric hospitalization.
• Current or prior diagnosis of psychosis (ICD10 F2x diagnosis), bipolar affective disorder (ICD10 F31.x diagnosis) or depression with psychotic symptoms (ICD10 F32.3 or F33.3 diagnosis).
• Currently pregnant.

Sponsors & Collaborators

• Regionshospitalet Silkeborg: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Regionshospitalet Silkeborg

Silkeborg, Denmark

Location

Related Publications (1)

• Madsen MM, Trolle C, Fynne LV, Colombo M, Pedersen RL, Sorensen VN, Christensen SR, Fink P, Gormsen LK. Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial. Contemp Clin Trials. 2025 Nov;158:108082. doi: 10.1016/j.cct.2025.108082. Epub 2025 Sep 17.

  PMID: 40972891 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Fatigue Syndrome, Chronic; Somatoform Disorders

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Michael M Madsen, MD MPH MSc

  Regionshospitalet Silkeborg

  PRINCIPAL INVESTIGATOR

• Lise K Gormsen, MD PhD

  Funktionelle Lidelser, Aarhus Universitetshospital

  STUDY CHAIR

• Christian Trolle, MD PhD

  Regionshospitalet Silkeborg

  STUDY DIRECTOR

• Per Fink, MD Dr. Med PhD

  Funktionelle Lidelser, Aarhus Universitetshospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Outcome data is blinded to the investigator during data analysis as to intervention vs. comparison arm assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant and Medical Doctor

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 6, 2023
• Study Start: June 1, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)