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A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes.

Ravyts SG, Erickson AJ, Washington DL, Yano EM, Carlson GC, Mitchell MN, Kelly M, Alessi CA, McGowan SK, Song Y, Martin JL, Dzierzewski JM. A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. Journal of psychosomatic research. 2023 Oct 21; 175:111536.

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OBJECTIVE: Insomnia is known to exacerbate pain symptoms. The purpose of the present study was to compare the secondary effects of cognitive behavioral therapy for insomnia (CBTI) against a novel treatment for insomnia called acceptance and behavioral changes for insomnia (ABC-I) among individuals with comorbid pain. Differences in the potential mechanisms through which these treatments impact pain were also examined. METHODS: Data consisted of a secondary analysis from a randomized comparative effectiveness trial of CBT-I and ABC-I among women veterans with insomnia and comorbid pain. Pain outcomes, beliefs about sleep, and psychological flexibility were assessed at baseline, post-treatment, and at three-months follow-up. RESULTS: At baseline, 93 women veterans reported comorbid insomnia and pain (mean age  =  46.7; 33.3% Black, 24.7% Hispanic/Latina). Both CBT-I (n  =  48) and ABC-I (n  =  45) were associated with decreased pain intensity (p  <  .001, Cohen''s d  =  0.41-0.67) and pain interference (p  <  .001, Cohen''s d  =  0.71-0.77) at post-treatment and three-months follow-up, with results indicating that ABC-I was non-inferior to CBT-I for pain improvement. Both conditions were associated with greater psychological flexibility post-treatment, and CBT-I resulted in larger reductions in dysfunctional beliefs about sleep (p  =  .01, Cohen''s d  =  0.59). CONCLUSION: CBT-I and ABC-I both had positive secondary effects on pain with ABC-I being non-inferior to CBT-I with respect to its impact on pain. The mechanisms of change associated with these treatments may differ with CBT-I leading to greater reductions in dysfunctional beliefs. Hybrid treatments which incorporate an acceptance and commitment approach to both insomnia and pain warrant further examination.

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