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Table 1 Eligibility criteria

From: Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation

Criteria Rationale
Inclusion criteria
1. >45 years of age; chronic pain (pain ≥3 months duration in any body region by self-report) Older people with chronic pain are disproportionately affected by harms from prescribed opioids such as overdose and death [36]
2. On LTOT (any opioid at any dose for ≥3 months by self-report) Known contribution of LTOT to depression and secondary outcome of reducing opioid use/dose [13]
3. Comorbid depressive symptoms of mild to moderate severity (PHQ-9 score 10–19) People with subsyndromal depressive symptoms (PHQ-9 score 5–9) are less likely to show an effect from any intervention
4. Understanding of English language; able to sit for 20–25 min without significant discomfort; be willing and able to attend all four training sessions of SSM/HEP, as well as 75% of follow-up sessions Ensure ability to participate in interventions which will be delivered in English only and mostly in a seated position
Exclusion criteria
1. Psychiatric conditions other than depression, including substance use disorder, psychosis and cognitive impairment as established by the MINI; severe depression (PHQ-9 ≥20) and risk of imminent suicide as per MINI and PHQ-9; noncorrectable, clinically significant sensory impairment; acutely unstable physical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months; a terminal medical diagnosis with prognosis of less than 12 months People with these attributes are theoretically less likely to benefit from the group meditation intervention and/or HEP control condition. People with severe depression (i.e., PHQ-9 ≥20) may need a standard intervention (e.g., psychotherapy, antidepressant medications). In certain cases, a patient’s symptoms may worsen (e.g., patients with psychosis) or the patient may be too frail to complete the study (e.g., medically unstable patients) [37]
2. Currently practicing any form of mind–body intervention To limit confounding variables
3. Inability to provide informed consent As per ethical norms for research involving human subjects
  1. Abbreviations: HEP Health Enhancement Program, LTOT Long-term opioid therapy, MINI Mini-International Neuropsychiatric Interview, PHQ-9 Patient Health Questionnaire, SSM Sahaj Samadhi Meditation