Pilot study of DTx app for chronic pain

JRCT ID: jRCTs042240117

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic pain (Primary chronic musculoskeletal pain and widespread chronic pain)
• Date of first enrollment: 30/10/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): In this study, an application that incorporates cognitive-behavioral therapy techniques for chronic pain (Cognitive Behavioral Therapy Application) will be used. Based on the understanding that when pain persists in chronic pain patients, the way they perceive things (cognitive evaluation) becomes pessimistic and their behavior and mood (emotion) are influenced in a negative direction, Cognitive Behavioral Therapy (CBT) uses a pain-induced, non-f unctional Cognitive Behavioral Therapy (CBT) aims to alleviate the suffering associated with chronic pain by reviewing the non-functional ways of perceiving things (cognitive evaluation) and behavior p atterns affected by pain, identifying where the vicious cycle is occurring, and working on cognition and behavior to break the vicious cycle in order to stabilize mood (emotion).

Outcome(s)

• Primary Outcome: Change in Numerical rating scale (NRS) (average weekly score) from baseline (week 0) to end of int ervention (week 8)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takahiro Ushida