Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodi… (NCT04870476) | Clinical Trial Compass
WithdrawnNot Applicable
Feasibility and Acceptability of the Internet-delivered Treatment "One Step at the Time" for Bodily Distress Syndrome
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.
0Started 2021-09-19
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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
What they're measuring
1
Changes in physical Health
Timeframe: Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 months)
✕. 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