Chronic pain (Primary chronic musculoskeletal pain and widespread chronic pain)
Conditions
Interventions
Sponsors
Takahiro Ushida
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pain lasting more than 3 months at the time of consent, diagnosed by a physician a s chronic pain, and with NRS(Numerical rating sca le) score of 4 or higher 2)Patients who are classified by the physician as having primary chronic musculoskeletal pain and widespread chronic pain 3)Patients who are at least 18 years old and less than 75 years old at baseline evaluation (week 0) 4)Patients who can use the app (iOS/Android eq uipped, see 2.5.1 for version) using a smartphone 5)Patients who agree to receive cognitive behavi oral therapy using the app 6)Patients who can make a treatment/visit plan f or at least 2 months 7)Patients who can make outpatient visits accord ing to the study schedule 8)Patients who are clinically judged by the physi cian to have sufficient physical function, such as n o cognitive impairment, for participation in the stu dy 9)Patients who have received a thorough explan ation of their participation in the study, and who h ave given their free and voluntary written consent, based on a thorough understanding of the study
Exclusion criteria
Exclusion criteria: 1)Patients who are current or former recipients o f other cognitive behavioral therapy programs for pain 2)Patients with alcohol and drug use disorders 3)Patients with hypomanic episodes, manic episodes, or psychotic episodes 4)Patients with impending thoughts of death 5)Patients requiring a surrogate 6)Patients who are judged to be inappropriate for the study by the principal investigator or sub-inv estigator who was in charge of patient enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Numerical rating scale (NRS) (average weekly score) from baseline (week 0) to end of int ervention (week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Pain intensity: Change in Numerical rating scale (NRS) (1-week average score) from baseline (we ek 0) at 3 weeks and at 5 weeks 2)Pain catastrophizing scale (PCS) score change f rom baseline (week 0) at 3 weeks, at 5 weeks, and at the end of the intervention 3)Pain disability: change from baseline (week 0) in Pain Disability Index (PDI) scores at 3 weeks, 5 weeks, and end of intervention 4)Insomnia: change from baseline (week 0) in Athens Insomnia Scale (AIS) scores at 3 weeks, 5 weeks, and end of intervention 5)Health QOL: change from baseline (week 0) in EQ-5D-5L utility values at 3 weeks, 5 weeks, and end of intervention 6)Depression and anxiety symptoms: change fro m baseline (week 0) in Hospital Anxiety Depressio n Scale (HADS) scores at 3 weeks, 5 weeks, and at the end of intervention 7)Subjective symptoms: Changes from baseline to the end of the intervention in the number of occurrence of pain symptoms, intensity of pain, level of mood, and level of physical condition based on subjective symptom records entered into the app. 8)Adherence: trends from baseline to end of intervention in app use, including session completion rate, subjective symptom recording rat e, and app activation rate 9)Usability: Qualitative and quantitative evaluation of the usability/usability of the app through questionnaires and interviews at the end of the intervention 10)Treatment satisfaction: Treatment satisfaction was evaluated qualitatively and quantitatively thro ugh questionnaires and interviews at the end of the intervention | — |
Contacts
Public ContactUshida Takahiro
Aichi Medical University Hospital
Outcome results
None listed