Chronic pain (Primary chronic musculoskeletal pain and widespread chronic pain)
Conditions
Interventions
Sponsors
Wakaizumi Kenta
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 as chronic pain, and with NRS(Numerical rating scale) 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 equipped, see 2.5.1 for version) using a smartphone (5) Patients who agree to receive cognitive behavioral therapy using the app (6) Patients who can make a treatment/visit plan for at least 2 months (7) Patients who can make outpatient visits according to the study schedule (8) Patients who are clinically judged by the physician to have sufficient physical function, such as no cognitive impairment, for participation in the study. (9) Patients who have received a thorough explanation of their participation in the study, and who have 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 of 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-investigator 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 intervention (week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pain intensity: Change in Numerical rating scale (NRS) (1-week average score) from baseline (week 0) at 2 weeks and at 5 weeks 2) Pain catastrophizing scale (PCS) score change from baseline (week 0) at 2 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 2 weeks, 5 weeks, and end of intervention 4) Level of neuropathic pain: change from baseline (week 0) in PainDETECT scores at 2 weeks, 5 weeks, and end of intervention 5) Ruminative thinking: change from baseline (week 0) in Ruminative Responses Scale (RRS) scores at 2 weeks, 5 weeks, and end of intervention 6) Insomnia: change from baseline (week 0) in Athens Insomnia Scale (AIS) scores at 2 weeks, 5 weeks, and end of intervention 7) Intropersistence: change from baseline (week 0) in Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 2 weeks, 5 weeks, and at the end of the intervention. 8) Health QOL: change from baseline (week 0) in EQ-5D-5L utility values at 2 weeks, 5 weeks, and end of intervention 9) Wellbeing: change from baseline (week 0) in Satisfaction With Life Scale (SWLS) scores at 2 weeks, at 5 weeks, and at the end of the intervention 10) Personality traits: change from baseline (week 0) in personality traits using the Todai egogram (TEG) at the end of the intervention 11) Depression and anxiety symptoms: change from baseline (week 0) in Hospital Anxiety Depression Scale (HADS) scores at 2 weeks, 5 weeks, and at the end of intervention 12) 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. 13) Adherence: trends from baseline to end of intervention in app use, including session completion rate, subjective symptom recording rate, and app activation rate 14) Usability: Qualitative and quantitative ev | — |
Contacts
Public ContactKenta Wakaizumi
Keio University Hospital
Outcome results
None listed