Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders

NCT05525598 | Recruiting DMC

• 1 other identifier: OneStep v2.0
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program "One step at a time" designed for the treatment of patients with moderate to severe functional somatic disorder (FSD). The trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with "One step at a time") or the active control condition ("GetStarted"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established single/oligo-organ or multi-organ FSD diagnosis, with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.

Conditions

Bodily Distress Disorder Moderate; Bodily Distress Disorder Severe; Fibromyalgia; Chronic Fatigue Syndrome; Irritable Bowel Syndrome; Somatization

Outcome Measures

Primary Outcomes (2)

• Change in SF-36 physical health (SF-36 PPH scales)

  The SF-36 is a self-reported physical, mental, and social health. Analysis of primary outcome will be based on the PPH subscales. The change that is used to test the main hypothesis is the change from baseline (0 weeks) to 3-month follow-up (26 weeks). The full SF-36 is measured at the following time-points: Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks). During During treatment (week 3, 6, 9), only the SF-36 PPH subscales (Bodily pain, physical functioning, vitality) will be measured.

  Pre-assessment (-2 weeks), baseline (0 weeks), during treatment (weeks 3, 6, and 9), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks)

• Clinical Global Improvement Scale (CGI)

  Single item 5-point self-reported evaluation of overall health improvement. The time point that is used to test the main hypothesis at 3-month follow-up (26 weeks). The CGI is measured on the following time points: After treatment (14 weeks), at 3-month follow up (26 weeks), at 12-month follow up (62 weeks)

  3-month follow up (26 weeks)

Secondary Outcomes (22)

• The Numeric Rating Scale (NRS)

  Pre-assessment (-2 weeks), Baseline (0 weeks), During treatment (weeks 3, 6, and 9), After treatment (14 weeks), and at 3 month follow up (26 weeks) at 12 month follow up (62 weeks)

• Emotional distress, anxiety, depression subscales of the 92-item Danish version of the Symptom Checklist (SCL-92)

  Pre-assessment (-2 weeks), Baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12 month follow up (62 weeks).

• The BDS Checklist-25

  Pre-assessment (-2 weeks), Baseline (0 weeks), after treatment (14 weeks) at 3 month follow up (26 weeks) and at 12 month follow up (62 weeks).

• Whiteley-6 revised

  Pre-assessment (-2 weeks), baseline (0 weeks), after treatment (14 weeks), at 3-month follow up (26 weeks), and at 12-month follow up (62 weeks)

• Brief Illness perception questionnaire (b-IPQ)

  Pre-assessment (-2 weeks), Baseline (0 weeks), during treatment (weeks 3, 6, and 9), After treatment (14 weeks), at 3 month follow up (26 weeks) and at 12 month follow up (62 weeks)

Other Outcomes (5)

• Automatic log data

  Data is logged throughout entire treatment period. This data will be collected from baseline (0 weeks) and throughout the treatment period (week 14).

• End-of-module evaluation

  Not time specific, but collected throughout the usage-period, when users complete a module. This data will be collected from baseline (0 weeks) and throughout the treatment period (week 14)

• Assessing medical doctor evaluation

  Immediately following assessment (-2 weeks), after 3 month follow-up assessment (30 weeks)

Study Arms (2)

Internet-delivered therapist-assisted treatment: "One step at the time"

EXPERIMENTAL

"One step at the times" consists of 11 internet-delivered modules delivered over 14 weeks. Each module explores a different theme, primarily including elements from Cognitive Behavioral Therapy (CBT) for FSD, and includes FSD-related psychoeducation, various interactive exercises, and video and audio material. Interactions between patients and the therapist will take place via the telephone 3 times (start, mid-term, and end-of-treatment) and embedded messaging (therapist will respond to patients) approx. 2 times a week. The participating therapists are supervised every other week by specialized psychologists.

Behavioral: "One step at a time"

Internet-delivered non-guided treatment: "Get started"

ACTIVE COMPARATOR

"Get started" is a non-guided self-help program, developed as an active control, that includes 4 modules consisting of FSD-related psychoeducation and guidance on making lifestyle improvements. Participants will have access to the "Get started" program for 14 weeks.

Behavioral: "Get started"

Interventions

"One step at a time" BEHAVIORAL

\[see 'arms' section for full description\]

Internet-delivered therapist-assisted treatment: "One step at the time"

"Get started" BEHAVIORAL

\[see 'arms' section for full description\]

Internet-delivered non-guided treatment: "Get started"

Eligibility Criteria

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

You may qualify if:

• Patients must fulfil the criteria for moderate-severe FSD operationalized as being diagnosed with either single/oligo-organ BDS, with 2 organ systems that are each affected by 3 or more symptoms, or multi-organ BDS, with 3 or 4 organ systems that are each affected by 3 or more symptoms.
• Patients must have symptom duration \> 6 months.
• If older than 25, patients must have been active in the labor market or educational system for at least 12 months during the last 2 years.
• Patient must have access to a computer or tablet with internet connection.
• Patient must be able to understand, read, and write Danish fluently.

You may not qualify if:

• Patients are excluded from participation if they present with severe comorbid somatic or psychiatric disease that is insufficiently treated at the time of assessment and is deemed to constitute a potential barrier for engaging in the treatment.
• Patients are excluded if they lack motivation to engage in internet-delivered treatment.
• Patients are excluded if they have poor self-reported IT skills.
• Patients are excluded if they lack informed consent.
• Patients are excluded if they have ongoing treatments with opioids and benzodiazepines.
• Patient's use of psychoactive medications should be stable.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (1)

Department of Functional Disorders

Aarhus C, Denmark, 8000, Denmark

RECRUITING

Related Publications (5)

• Schroder A, Rehfeld E, Ornbol E, Sharpe M, Licht RW, Fink P. Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial. Br J Psychiatry. 2012 Jun;200(6):499-507. doi: 10.1192/bjp.bp.111.098681. Epub 2012 Apr 26.

  PMID: 22539780 BACKGROUND

• Fjorback LO, Arendt M, Ornbol E, Walach H, Rehfeld E, Schroder A, Fink P. Mindfulness therapy for somatization disorder and functional somatic syndromes: randomized trial with one-year follow-up. J Psychosom Res. 2013 Jan;74(1):31-40. doi: 10.1016/j.jpsychores.2012.09.006. Epub 2012 Oct 1.

  PMID: 23272986 BACKGROUND

• Pedersen HF, Agger JL, Frostholm L, Jensen JS, Ornbol E, Fink P, Schroder A. Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care - CORRIGENDUM. Psychol Med. 2018 Dec;48(16):2804. doi: 10.1017/S0033291718002799. Epub 2018 Sep 11. No abstract available.

  PMID: 30203729 BACKGROUND

• Frolund Pedersen H, Holsting A, Frostholm L, Rask C, Jensen JS, Hoeg MD, Schroder A. "Understand your illness and your needs": Assessment-informed patient education for people with multiple functional somatic syndromes. Patient Educ Couns. 2019 Sep;102(9):1662-1671. doi: 10.1016/j.pec.2019.04.016. Epub 2019 Apr 17.

  PMID: 31023608 BACKGROUND

• Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.

  PMID: 12719681 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Fatigue Syndrome, Chronic; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisbeth Frostholm, Ph.D.

  Aarhus Universityhospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas T Lamm, MSc

CONTACT

61147069; THLAMM@rm.dk

Lisbeth Frostholm, Ph.D.

CONTACT

22618875; lisbeth.frostholm@aarhus.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 1, 2022
• Study Start: August 24, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)