Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: A non-inferiority randomized controlled trial.
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ABSTRACT: Study objectives
Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this non-inferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).Methods
A total of 177 cancer patients were randomized to: 1) StanCBT-I (6 face-to-face CBT-I sessions; n=59); or 2) StepCBT-I (n=118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n=65), while those with a more severe insomnia received 6 face-to-face CBT-I sessions (n=53). In both cases, patients could receive up to 3 booster sessions of CBT-I if they still had insomnia symptoms following this first step.Results
Results indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that were not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps<.001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue and quality of life scores.Conclusion(s)
The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.
SUBMITTER: Savard J
PROVIDER: S-EPMC8598200 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT), was noninferior, less costly to deliver, and as acceptable to patients compared to tCBT alone. Adults with a diagnosis of major depressive episode (MDE) were randomized to receive up to 20 weeks of stepped care or tCBT. Stepped care (n = 134) was noninferior to tCBT (n = 136) with an end-of-treatment effect size of d = 0.03 and a 6-month post-treatment effect size of d = -0.07 [90% CI 0.29 to 0.14]. Therapist time in stepped care was 5.26 (SD = 3.08) hours versus 10.16 (SD 4.01) for tCBT (p < 0.0001), with a delivery cost difference of $-364.32 [95% CI $-423.68 to $-304.96]. There was no significant difference in pre-treatment preferences (p = 0.10) or treatment dropout (39 in stepped care; 27 in tCBT; p = 0.14). tCBT patients were significantly more satisfied than stepped care patients with the treatment they received (p < 0.0001). These findings indicate that stepped care was less costly to deliver, but no less effective than tCBT. There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01906476.
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Project description:Study objectivesTo determine if a population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia (ICBT-I) affects dispensed medications and provider encounters compared with usual care.MethodsA pragmatic hybrid study design was used to evaluate both the implementation strategy and the long-term effects of ICBT-I on health care utilization in an integrated health system. Adult members with insomnia (a diagnosis or insomnia medication dispensation) or at high risk of insomnia (a diagnosis of depression or anxiety) were randomized to receive information on either an ICBT-I program (intervention arm) or in-person classes on insomnia (usual-care arm). Outcomes included dispensed insomnia medications and provider encounters over 12 months. The effectiveness of our implementation of ICBT-I on the target population was determined by an intention-to-treat analysis and by regression models comparing those who engaged in ICBT-I with matched usual-care arm controls.ResultsA total of 136,630 participants were randomized. Six hundred thirty-eight (0.96%) accessed the ICBT-I program while 431 (0.66%) attended 1 or more usual-care insomnia classes. Dispensed insomnia medications and provider encounters were no different in the ICBT-I arm vs the usual-care arm (intention-to-treat) or among those who engaged in ICBT-I vs matched usual-care arm controls.ConclusionsSince ICBT-I program engagement was low, additional strategies to improve engagement should be explored. ICBT-I did not result in a reduction in several measures of health care utilization; nevertheless, it offers an alternative and accessible approach to managing population insomnia.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications; URL: https://clinicaltrials.gov/ct2/show/NCT03313466; Identifier: NCT03313466.CitationDerose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021;17(8):1675-1684.
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Project description:BACKGROUND:Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, this study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile apps in the improvement of mental health. OBJECTIVE:The aim of this study was to examine the efficacy of 3 mobile app-based programs: mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation program in improving mental well-being and reducing psychological distress. Changes in mindful awareness and self-compassion were also assessed. To further delineate the suitability of each program for different types of individuals, individual difference variables (ie, discomfort with emotions and tolerance for ambiguity) were explored for potential moderation. METHODS:This study was a 3-arm, randomized, controlled, noninferiority trial examining the efficacy of mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation. Participants were randomized into either 1 of the 3 conditions. Throughout the 4-week, 28-session program, participants spent 10-15 min daily reviewing the course content and practicing various related exercises. At preprogram, postprogram, and 3-month follow-up, participants also completed Web-based measures of mental well-being, psychological distress, mindful-awareness, and self-compassion as well as the proposed moderators. RESULTS:Among the 2161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment, respectively. All 3 conditions (mindfulness-based program: N=703; cognitive behavioral psychoeducation: N=753; self-compassion program: N=705) were found to be efficacious in improving mental well-being and reducing psychological distress. All conditions enhanced mindful awareness at postprogram. Significant interaction effect was found on self-compassion; cognitive behavioral psychoeducation and self-compassion program, but not mindfulness-based program, significantly enhanced self-compassion at postprogram. No significant differences regarding usage and users' satisfaction were found among the 3 conditions. None of the proposed moderators were found to be significant. CONCLUSIONS:Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile apps were efficacious in improving mental well-being and reducing psychological distress among adults at postprogram and 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rates that are common in app-based health promotion programs. TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; http://www.chictr.org.cn/hvshowproject.aspx?id=6220 (Archived by WebCite at http://www.webcitation.org/734PlOz50).
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