Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome

NCT04870476 | Withdrawn DMC

• 1 other identifier: OneStep 1.0
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This uncontrolled feasibility pilot study explores the acceptability and potential effect of a 14 week, 11-module, therapist-assisted, internet-delivered treatment program, "One step at the time", for patients moderately affected by Bodily Distress Syndrome. The study includes 25 participants aged 18-60 with multiple functional somatic symptoms for a duration of minimum 6 months. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is a +2.0 points change in patient-rated physical health measured by the SF-36 aggregate score physical health from before to after treatment.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes in physical Health

  Patient-rated physical health measured by the SF-36 aggregate score Physical Health

  Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 months)

Secondary Outcomes (13)

• SF-36 physical health

  Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)

• 5-point clinical global improvement scale (CGI)

  after treatment (14 weeks)

• The Numeric Rating Scale

  every 2 weeks during treatment

• Relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92)

  Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)

• The BDS Checklist

  Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)

Other Outcomes (5)

• Patients' experience and satisfaction with assessment and treatment

  During treatment

• 5-point clinical global improvement scale (CGI)

  After treatment (16 weeks)

• Therapist time spent per patient

  During treatment

Study Arms (1)

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

EXPERIMENTAL

Internet-delivered treatment: "One step at the time". All participants receive the internet-delivered therapist-assisted 11-modules treatment program "One step at the time".

Behavioral: Internet-delivered treatment: "One step at the time"

Interventions

Internet-delivered treatment: "One step at the time" BEHAVIORAL

The guided internet treatment program consists of 11 modules (+ 1 module for relatives) activated consecutively over a period of 14 weeks. The content is written psychoeducation, patient videos, audio exercises and exposure exercises. The program is therapist-guided; hence all patients will receive support primarily from a specific therapist during the 14 weeks.

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

Eligibility Criteria

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

You may qualify if:

• Meet the diagnostic criteria for Bodily distress syndrome (BDS) with 2-3 of 4 symptom clusters
• Moderate impact on daily life (self-reliant at home, can participate in activities outside the home)
• Symptoms lasting for at least 6 months
• Previous stable educational or occupational attachment until at least 2 years prior to enrollment and expecting to return to occupational or educational activity
• Motivation and time to participate in a psychological treatment program for treatment of BDS
• IT skills and access to internet and computer/tablet
• Willingness to engage in working with illness perception and behavioral change

You may not qualify if:

• Presence of other physical condition if the symptoms of this condition can not clearly be separated from symptoms of BDS or the condition is unstable/untreated
• Current moderate or severe psychiatric disorder that substantially impacts daily life or demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression or personality disorder
• Current continuous treatment with opioids and drugs with opioid-like properties
• Previous psychological treatment targeting BDS

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

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

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; Mental Disorders

Study Officials

• Lisbeth Frostholm, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: May 3, 2021
• Study Start: September 19, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share