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

Primary Purpose

Bodily Distress Disorder Moderate, Fibromyalgia, Chronic Fatigue Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-delivered treatment: "One step at the time"
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bodily Distress Disorder Moderate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet the diagnostic criteria for Bodily distress syndrome (BDS) with 2-3 of 4 symptom clusters
  2. Moderate impact on daily life (self-reliant at home, can participate in activities outside the home)
  3. Symptoms lasting for at least 6 months
  4. 18-60 years at the time of inclusion
  5. Previous stable educational or occupational attachment until at least 2 years prior to enrollment and expecting to return to occupational or educational activity
  6. Motivation and time to participate in a psychological treatment program for treatment of BDS
  7. IT skills and access to internet and computer/tablet
  8. Willingness to engage in working with illness perception and behavioral change

Exclusion Criteria:

  1. 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
  2. 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
  3. Current continuous treatment with opioids and drugs with opioid-like properties
  4. Previous psychological treatment targeting BDS

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

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

    Arm Description

    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".

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    SF-36 physical health
    Changes in physical, mental, and social health
    5-point clinical global improvement scale (CGI)
    Overall health improvement
    The Numeric Rating Scale
    Changes in symptom intensity and symptom interference
    Relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92)
    Changes in symptoms of anxiety, depression, and somatization
    The BDS Checklist
    Symptom checklist
    Whiteley-7
    Changes in illness worry
    Brief-Illness perception questionnaire
    Changes in illness perception
    The Behavioural Responses to Illness Questionnaire (BRIQ) Changes in illness behaviour
    Changes in illness behaviour
    The credibility/expectancy questionnaire
    Treatment expectancy, rationale credibility, and treatment satisfaction
    Costs associated with Psychiatric Illness (TiC-P)
    Changes in work performance and work absence
    The inventory for the assessment of negative effects of psychotherapy (INEP)
    Negative effects of psychotherapy
    The Internet Evaluation and Utility Questionnaire
    Program utility
    The Sources of Meaning and Meaning in Life Questionnaire (SoMe short version)
    Chnages in sense of meaningfulness and crisis of meaning

    Full Information

    First Posted
    February 17, 2020
    Last Updated
    October 7, 2022
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04870476
    Brief Title
    Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome
    Official Title
    "One Step at a Time" - an Internet-delivered Treatment for Patients Moderately Impaired by Bodily Distress Syndrome. A Feasibility Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    "During the feasibility study, it came to the research group's attention, that data was collected in an unauthorized manner. Therefore the trial has been terminated.
    Study Start Date
    September 19, 2021 (Actual)
    Primary Completion Date
    November 15, 2021 (Actual)
    Study Completion Date
    November 15, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    "One Step at the Time" - Internet-delivered Treatment for Patients Moderately Impaired by Bodily Distress Syndrome. A Feasibility Pilot Study. Lisbeth Frostholm, Andreas Schröder, Johanne Liv Agger, Heidi Frølund Pedersen Objective The objective of this uncontrolled pilot study is to test the feasibility of a future RCT by exploring the acceptability and effect of an internet-delivered treatment program, "One step at the time", for patients moderately affected by Bodily Distress Syndrome (BDS). 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 an a priori defined change in patient-rated physical health from before to after treatment. Design This study is designed as an uncontrolled, single-arm, single-center feasibility pilot study. Participants The study includes 25 participants included from February to July 2020. The participants are recruited from The Research Clinic for Functional Disorders and Psychosomatics and The Pain and Headache Clinic, Aarhus University Hospital, Denmark, to which patients with multiple functional somatic symptoms are consecutively referred from GPs, medical specialists and hospital departments. Patients moderately affected by multiple symptoms are screened for eligibility by the eligibility criteria below. They undergo thorough diagnostic assessment by a medical doctor specialized in functional disorders after a thorough physical and psychological assessment including diagnostic interview (Schedules for Clinical Assessment in Neuropsychiatry), physical examination including blood pressure, blood test and a review of all medical records. Eligibility criteria Inclusion criteria: 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 18-60 years at the time of inclusion 8. Previous stable educational or occupational attachment until at least 2 years prior to enrollment and expecting to return to occupational or educational activity 10. Motivation and time to participate in a psychological treatment program for treatment of BDS 11. IT skills and access to internet and computer/tablet 12. Willingness to engage in working with illness perception and behavioral change Exclusion criteria: 5. 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 6. 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 7. Current continuous treatment with opioids and drugs with opioid-like properties 9. Previous psychological treatment targeting BDS Intervention "One step at the time" is a newly developed internet-delivered therapist-assisted treatment program for patients with BDS. The 11 modules + 1 module for relatives are primarily text-based but also contain audio files with guided exercises and videos with former patients. During a period of 14 weeks, patients are guided through the program modules assisted by a trained psychologist or psychiatrist. Course If eligible and willing to participate, patients are included in the pilot study and assigned to a therapist (a trained psychologist or psychiatrist from The Research Clinic for Functional Disorders). Patients are contacted by telephone by the therapist and guided to login to the program platform and initiate treatment. The therapist follows the patient through the 11 treatment modules and provides guidance when needed. Patients and therapists primarily communicate through asynchronously written messages, and occasionally by telephone. Treatment duration is 14 weeks. Measurements Patient-rated outcome measures are collected through a web-based program at the time of screening (before inclusion) (T0, baseline), before treatment (T1, 2 weeks), at end of treatment (T3, 16 weeks) and at 3 months after treatment (follow-up, 28 months) (T4). Clinician-rated outcome measures are collected at the time of diagnostic assessment and at end of treatment. Patient-rated measures include: physical, mental, and social health measured by SF-36 with emphasis on the aggregate score physical health overall health improvement measured by the 5-point clinical global improvement scale (CGI) symptom intensity and symptom interference measured by The Numeric Rating Scale symptoms of anxiety, depression, and somatization measured by relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92) bodily symptoms measured by The BDS Checklist illness worry measured by Whiteley-7 illness perception measured by Brief-IPQ illness behaviour measured by BRIQ sense of meaningfulness measured by The Sources of Meaning and Meaning in Life Questionnaire (SoMe short version) treatment expectancy, rationale credibility, and treatment satisfaction measured by the credibility/expectancy questionnaire work performance and work absence measured questionnaire for Costs associated with Psychiatric Illness (TiC-P) demographic variables negative effects of psychotherapy measured by the inventory for the assessment of negative effects of psychotherapy (INEP) program utility measured by the Internet Evaluation and Utility Questionnaire patients' experience and satisfaction with assessment and treatment measured by questionnaires and qualitative semi-structured interviews Other measures include: clinician-rated improvement measured by the 5-point clinical global improvement scale (CGI), therapist time spent per patient clinician-rated program utility measured by the Internet Evaluation and Utility Questionnaire recruitment and retention rates and data completeness. Feasibility outcomes 1) Changes in patient-rated physical health from before to after the treatment measured by the SF-36 aggregate score Physical Health. Recruitment and retention rates, time requirements and data completeness as measured by the rate of eligible patients willing to participate, the rate of included patients completing the treatment program (defined as completion of at least 5 modules), therapists' time spent per patient, and the rate of treatment completers providing full data. Patients' treatment satisfaction and assessment of program utility as measured by the credibility/expectancy questionnaire, a patient satisfaction questionnaire and the internet evaluation and utility questionnaire. Patients' and therapists' impression of treatment effect as measured by the clinical global improvement 5-point Likert scale). Feasibility criteria We regard a future study testing the treatment program "One step at the time" in an RCT as feasible if: A mean change in the SF-36 aggregate score Physical Health is at least +2.0 points from baseline (T0, baseline) or inclusion (T1, 2 weeks) to end of treatment (T2, 16 weeks) for treatment completers. 75% of the patients included in the study complete the treatment program (defined as completion of at least 5 of 11 modules) and 90% of treatment completers provide full data

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bodily Distress Disorder Moderate, Fibromyalgia, Chronic Fatigue Syndrome, Irritable Bowel Syndrome, Somatization Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Internet-delivered treatment: "One step at the time"
    Arm Type
    Experimental
    Arm Description
    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".
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-delivered treatment: "One step at the time"
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in physical Health
    Description
    Patient-rated physical health measured by the SF-36 aggregate score Physical Health
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 months)
    Secondary Outcome Measure Information:
    Title
    SF-36 physical health
    Description
    Changes in physical, mental, and social health
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Title
    5-point clinical global improvement scale (CGI)
    Description
    Overall health improvement
    Time Frame
    after treatment (14 weeks)
    Title
    The Numeric Rating Scale
    Description
    Changes in symptom intensity and symptom interference
    Time Frame
    every 2 weeks during treatment
    Title
    Relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92)
    Description
    Changes in symptoms of anxiety, depression, and somatization
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Title
    The BDS Checklist
    Description
    Symptom checklist
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Title
    Whiteley-7
    Description
    Changes in illness worry
    Time Frame
    Baseline, before treatment, after treatment and at 3 month follow up
    Title
    Brief-Illness perception questionnaire
    Description
    Changes in illness perception
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Title
    The Behavioural Responses to Illness Questionnaire (BRIQ) Changes in illness behaviour
    Description
    Changes in illness behaviour
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Title
    The credibility/expectancy questionnaire
    Description
    Treatment expectancy, rationale credibility, and treatment satisfaction
    Time Frame
    Before treatment (2 weeks) and after treatment (16 weeks)
    Title
    Costs associated with Psychiatric Illness (TiC-P)
    Description
    Changes in work performance and work absence
    Time Frame
    Before treatment (2 weeks) and at 3 month follow up (16 weeks)
    Title
    The inventory for the assessment of negative effects of psychotherapy (INEP)
    Description
    Negative effects of psychotherapy
    Time Frame
    After treatment (16 weeks)
    Title
    The Internet Evaluation and Utility Questionnaire
    Description
    Program utility
    Time Frame
    after treatment (16 weeks)
    Title
    The Sources of Meaning and Meaning in Life Questionnaire (SoMe short version)
    Description
    Chnages in sense of meaningfulness and crisis of meaning
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)
    Other Pre-specified Outcome Measures:
    Title
    Patients' experience and satisfaction with assessment and treatment
    Description
    Qualitative semi-structured interviews
    Time Frame
    During treatment
    Title
    5-point clinical global improvement scale (CGI)
    Description
    Clinician-rated improvement
    Time Frame
    After treatment (16 weeks)
    Title
    Therapist time spent per patient
    Description
    Time spent per patient
    Time Frame
    During treatment
    Title
    The Internet Evaluation and Utility Questionnaire
    Description
    Clinician-rated program utility
    Time Frame
    After treatment (16 weeks)
    Title
    Recruitment and retention rates and data completeness.
    Description
    Rates of eligible patients willing to participate, completion rate (at least 5 modules) and data completeness.
    Time Frame
    Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 18-60 years at the time of inclusion 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisbeth Frostholm, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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