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Table 1 Protocol inclusion criteria, exclusion criteria, and patient measures

From: Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial

Inclusion

1) Aged between 18 and 65ā€‰years

2) Current LBP of at least 6ā€‰weeks duration and not currently seeking care for LBP

3) At least 3/10 pain on the numerical pain scale

4) Have current access to the internet

5) A score of ā‰¤ 24 on the Sleep Condition Indicator, which is indicative of sub-clinical insomnia symptoms in accordance to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition

Exclusion

1) Had known or suspected serious spinal pathology (e.g., fracture, metastatic, inflammatory or infective diseases and widespread neurological disorder)

2) Had spinal surgery within the last 12ā€‰months

3) Were using prescribed treatments for insomnia or depression

4) Were pregnant or lactating

5) Presented with severe symptoms of depression (scoreā€‰>ā€‰10), anxiety (>ā€‰7), or stress (>ā€‰12) according to the Depression Anxiety Stress Scales (DASS-21)

6) Reported poor physical or mental health (self-report 5-point Likert scale)

7) Reported substance use disorder

8) Were shift workers

Protocol patient measures

1) Pain self-efficacy questionnaire (PSEQ)

2) Patient-specific functional scale (PSFS)

3) Numerical pain rating scale (NRS) (Scale 0-100)

4) Roland Morris disability questionnaire (RMDQ)

5) International Physical Activity Questionnaire Short Form (IPAQ-SF)

6) Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

7) Insomnia Severity Index (ISI),

8) Sleep efficiency (SE)