Abstract
Cognitive-Behavioral Therapy has been recognized as the first-line treatment for chronic insomnia. No published study evaluated the long-term maintenance of clinical outcomes longer than three years. Non-randomized clinical series of 292 consecutive sleep clinic insomnia patients (mean age 40.7 ± 12.3 yrs, 38.4% males, 61.6% females) were included to evaluate the long-term effect of 7-session group CBT-I after a mean of 7.8 ± 1.6 years (range 4–10 yrs) from the end of treatment. Primary outcome was Insomnia Severity Index (ISI) score. Secondary outcomes included presence of insomnia relapses and how patients dealt with insomnia episode (i.e. use of drugs-D, use of cognitive-behavioral techniques-CBT, use of both-D+CBT). ISI score at pre-treatment baseline assessment (T0), end of treatment (T1) and follow-up (T2) were compared. 11% of patients did not complete ISI at T1 and 46% at T2, primarily due to loss of contact from relocating residence. Between patients who responded to follow-up evaluation and the ones who did not, there was no significant difference in terms of ISI scores at T0 and T1, age and duration of insomnia. A significant effect of treatment was observed in ISI score, F(1.78, 207.38) = 89.09, p < 0.001 across times without effect of the length of follow-up. 90.3% of patients no longer had clinical insomnia (ISI ≤14) at T1 (ISI 17 ± 4.5 at T0 vs 9.5 ± 4.2 at T1) and 78% at T2 (ISI score 9.9 ± 6.3 at T2). 89 patients (77%) reported at least one episode of insomnia relapse at T2. To deal with relapse, 29 patients (33%) took D, 38 patients (43%) used CBT and 22 patients (24%) used D+CBT. The lowest ISI score at T2 was found in patients who used only CBT-I techniques when facing relapse. Means ISI score were: D=13 ± 7.2, CBT=9 ± 6.2 (p<0.05), D+CBT=10.2 ± 5.5. CBT-I in group format resulted in clinically meaningful improvement as assessed by ISI at the end of treatment, and most of the patients sustained the improvement at a long-term follow-up. none.
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