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Withdrawn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
About this trial
This is an interventional treatment trial for Bodily Distress Disorder Moderate
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
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
NCT ID
NCT04870476
First Posted
February 17, 2020
Last Updated
October 7, 2022
Sponsor
University of Aarhus
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
Learn more about this trial
Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome
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