Table 3.
Modified Intention-to-Treat Analysis for Clinical Significance of Primary Outcomes for the Entire Sample and for the Subgroup Analysis of Participants with Severe Pain at Baseline
| Measure | Postintervention | 9-Month Follow-Up | Treatment Effect | Omnibus P-Valuea |
Pair-Wise P-Valueb |
||
|---|---|---|---|---|---|---|---|
| N | With 30% Reduction, n (%) |
N | With 30% Reduction, n (%) |
OR (95% Confidence Interval)c |
|||
| Entire sample | |||||||
| Insomnia severity | |||||||
| EOC | 122 | 36 (29.5) | 120 | 49 (40.8) | N/A | <.001 | N/A |
| CBT-P vs EOC | 117 | 33 (28.0) | 111 | 40 (35.7) | 0.81 (0.48–1.36) | .43 | |
| CBT-PI vs EOC | 113 | 62 (52.4) | 108 | 55 (50.5) | 2.20 (1.25–3.90) | .007 | |
| CBT-PI vs CBT-P | 2.72 (1.59–4.64) | <.001 | |||||
| Pain severity | |||||||
| EOC | 122 | 21 (17.2) | 120 | 29 (24.2) | N/A | .77 | N/A |
| CBT-P vs EOC | 117 | 20 (17.0) | 111 | 23 (20.5) | 0.79 (0.39–1.60) | N/A | |
| CBT-PI vs EOC | 113 | 23 (20.2) | 108 | 30 (27.5) | 0.96 (0.55–1.68) | N/A | |
| Participants with severe pain at baseline | |||||||
| Insomnia severity | |||||||
| EOC | 41 | 13 (31.7) | 40 | 16 (40.0) | N/A | .04 | N/A |
| CBT-P vs EOC | 42 | 13 (30.2) | 41 | 15 (35.7) | 0.75 (0.27–2.07) | .58 | |
| CBT-PI vs EOC | 48 | 25 (52.1) | 44 | 23 (52.3) | 2.41 (0.93–6.21) | .07 | |
| CBT-PI vs CBT-P | 3.21 (1.22–8.43) | .02 | |||||
| Pain severity | |||||||
| EOC | 41 | 10 (24.4) | 40 | 10 (25.0) | N/A | .79 | N/A |
| CBT-P vs EOC | 42 | 9 (20.9) | 41 | 12 (28.6) | 1.18 (0.49–2.85) | N/A | |
| CBT-PI vs EOC | 48 | 11 (22.9) | 44 | 14 (31.8) | 1.36 (0.57–3.24) | N/A | |
N/A = not applicable.
P-value for omnibus Wald test employing both posttreatment visits (postintervention and 9-months) controlled for baseline values, depression, cognitive status, opioid and hypnotic medication use, and clinic.
Pair-wise P-values for cognitive–behavioral therapy for pain (CBT-P) minus education-only control (EOC), cognitive–behavioral therapy for pain and insomnia (CBT-PI) minus EOC, and CBT-PI minus CBT-P. P-values correspond to a two-sided test of the null hypothesis that the difference between the two means is 0.
Odds ratio (OR) estimates from repeated-measures logistic regression adjusted for baseline values of relevant outcome, age, depression, modified Mini-Mental State Examination score, analgesic use, hypnotic use, an indicator of whether the outcome was measured at 9 months, and the clinic at which the intervention was delivered.