Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial.
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ABSTRACT:
SUBMITTER: Clarke G
PROVIDER: S-EPMC4418229 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
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Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial.
Clarke Greg G McGlinchey Eleanor L EL Hein Kerrie K Gullion Christina M CM Dickerson John F JF Leo Michael C MC Harvey Allison G AG
Behaviour research and therapy 20150414
We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12-20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n = 20), or an experimental condition consisting of CBT-I combined with CBT-D (n = 21). We assessed outcomes through 26 weeks of follow-up and found medium-large effects fav ...[more]
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Project description:Study objectivesInsomnia is a common precursor to depression; yet, the potential for insomnia treatment to prevent depression has not been demonstrated. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces concurrent symptoms of insomnia and depression and can be delivered digitally (dCBT-I); however, it remains unclear whether treating insomnia leads to sustained reduction and prevention of depression. This randomized controlled trial examined the efficacy of dCBT-I in reducing and preventing depression over a 1-year follow-up period.MethodsPatients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) insomnia disorder were randomly assigned to receive dCBT-I or an attentional control. The follow-up sample included 358 patients in the dCBT-I condition and 300 patients in the online sleep education condition. The primary outcome measure was relative rate ratios for depression at 1-year follow-up. Insomnia responses to treatment were also tested as predictors of incident depression at the 1-year follow-up.ResultsAt 1-year follow-up, depression severity continued to be significantly lower in the dCBT-I condition relative to control. In addition, the number of individuals who reported no depression at 1-year follow-up was 51% higher in the dCBT-I condition relative to control. In those with minimal to no depression at baseline, the incident rate of moderate-to-severe depression at 1-year follow-up was reduced by half in the dCBT-I condition relative to the control condition.ConclusiondCBT-I showed robust effects as an intervention that prevents depression. Future research should examine dose-response requirements and further characterize mechanisms of action of dCBT-I for depression prevention.Clinical trialSleep to Prevent Evolving Affective Disorders; NCT02988375.
| S-EPMC6783888 | biostudies-literature
Project description:Chronic insomnia (symptoms for ≥ 6 months) is the most common sleep disorder, affecting 6% to 10% of adults in the general population, with even higher rates in patients with comorbid conditions (eg, hypertension, 44%; cardiac disease, 44.1%; breathing problems, 41.5%). Traditionally, chronic insomnia occurring with another condition has been considered secondary and rarely received direct treatment because treatment of the primary condition was expected to improve the insomnia. However, this approach often failed because chronic insomnia is maintained by behaviors, cognitions, and associations that patients adopt as they attempt to cope with poor sleep but that end up backfiring (eg, increasing caffeine, spending more time in bed, trying harder to sleep). Cognitive behavioral treatment of insomnia (CBTi) targets those behaviors, cognitions, and associations and is effective across a variety of populations, including those with medical and psychologic comorbidities. Thus, in 2005, a National Institutes of Health expert consensus panel on chronic insomnia recommended dropping the term "secondary insomnia" in favor of the term "comorbid insomnia." Because CBTi does not carry the risks associated with some sleep medications (eg, dependency, polypharmacy, cognitive and psychomotor impairment), it is an attractive option for patients with other conditions. Through the Society of Behavioral Sleep Medicine (www.behavioralsleep.org) and the American Board of Sleep Medicine (www.absm.org), it is possible to find practitioners with expertise in CBTi (as well as other aspects of behavioral sleep medicine) and other behavioral sleep resources. Given the currently limited number of trained practitioners, exploration of alternative delivery methods (eg, briefer protocols, self-help, Internet) to improve access to this highly effective treatment and expanded training in these treatments are warranted.
| S-EPMC4694188 | biostudies-other
Project description:The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (<30-45 minutes), and delivers treatment in-person plus phone calls to cognitive behavioral therapy for insomnia (CBTI), which has 5 in-person sessions. The hypothesis was BBTI would be noninferior to CBTI. The Reliable Change Index was used to establish a noninferiority margin (NIM) of 3.43, representing the maximum allowable difference between groups on the pre-post Insomnia Severity Index change (ΔISI). Sixty-three veterans with chronic insomnia were randomized to either BBTI or CBTI and veterans in both groups had significant reductions of their insomnia severity per the ISI and improved their sleep onset latency, total wake time, sleep efficiency, and sleep quality per sleep diaries. While CBTI had a larger pre-post ΔISI, this was not significantly different than ΔISI BBTI and was less than the NIM. However, the 95% confidence interval of the between group pre-post ΔISI extended beyond the NIM, and thus BBTI was inconclusively noninferior to CBTI. Limitations, such as small sample size and high rate of dropout, indicate further study is needed to compare brief, alternative yet complementary behavioral insomnia interventions to CBTI. Still, evidence-based brief and flexible treatment options will help to further enhance access to care for veterans with chronic insomnia, especially in non-mental-health settings like primary care.
| S-EPMC10352919 | biostudies-literature
Project description:BackgroundAt least 40% of individuals with multiple sclerosis (MS) exercise chronic insomnia, and the prevalence is likely higher due to underdiagnosis. Poor sleep quality has been associated with increased fatigue, anxiety, depression, and risk of relapse in individuals with MS. While cognitive behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, the treatment effect of CBT-I in people with MS is unclear.ObjectiveThis pilot randomized control trial (RCT) assessed the feasibility and treatment effect of CBT-I to improve sleep quality and fatigue in individuals with MS with symptoms of insomnia.MethodsThirty-three individuals with MS (30 females, 3 males; 30 relapsing-remitting; 3 secondary-progressive; 53.0 ± 9.4 years old) with symptoms of insomnia were randomized into one of three arms: 1. 6-week CBT-I program, 2. 6-week active control, or 3. Single session of sleep education. Participants completed surveys to assess sleep quality, fatigue, sleep self-efficacy, depression, and anxiety.ResultsCBT-I in individuals with MS is feasible with high retention and adherence rate. All groups experienced a large magnitude of improvement in insomnia symptoms. The CBT-I and brief education groups experienced a large magnitude of improvement in sleep quality and fatigue. Only the CBT-I group demonstrated a large magnitude of improvement in sleep self-efficacy and depression.ConclusionThis is the first study to prospectively demonstrates that CBT-I is feasible in people with MS and produces promising improvements in insomnia severity, sleep quality, sleep self-efficacy and comorbid symptoms of fatigue, depression, and anxiety. Future studies are needed to determine mechanisms for these improvements and expand the scope of individuals with MS who may benefit from CBT-I. Furthermore, considering the moderate to large improvements experienced by the brief education group and the limited number of CBT-I providers, a stepped-care approach warrants consideration.
| S-EPMC7988499 | biostudies-literature
Project description:Study objectivesMore than half of young adults at risk for alcohol-related harm report symptoms of insomnia. Insomnia symptoms, in turn, have been associated with alcohol-related problems. Yet one of the first-line treatments for insomnia (Cognitive Behavioral Therapy for Insomnia or CBT-I) has not been tested among individuals who are actively drinking. This study tested (1) the feasibility and short-term efficacy of CBT-I among binge-drinking young adults with insomnia and (2) improvement in insomnia as a predictor of improvement in alcohol use outcomes.MethodsYoung adults (ages 18-30 years, 75% female, 73% college students) who met criteria for Insomnia Disorder and reported 1+ binge drinking episode (4/5+ drinks for women/men) in the past month were randomly assigned to 5 weekly sessions of CBT-I (n = 28) or single-session sleep hygiene (SH, n = 28). All participants wore wrist actigraphy and completed daily sleep surveys for 7+ days at baseline, posttreatment, and 1-month follow-up.ResultsOf those randomized, 43 (77%) completed posttreatment (19 CBT-I, 24 SH) and 48 (86%) completed 1-month follow-up (23 CBT-I, 25 SH). CBT-I participants reported greater posttreatment decreases in insomnia severity than those in SH (56% vs. 32% reduction in symptoms). CBT-I did not have a direct effect on alcohol use outcomes; however, mediation models indicated that CBT-I influenced change in alcohol-related consequences indirectly through its influence on posttreatment insomnia severity.ConclusionsCBT-I is a viable intervention among individuals who are actively drinking. Research examining improvement in insomnia as a mechanism for improvement in alcohol-related consequences is warranted.Trial registrationU.S. National Library of Medicine, https://clinicaltrials.gov/ct2/show/NCT03627832, registration #NCT03627832.
| S-EPMC7879415 | biostudies-literature
Project description:ObjectiveThis study aimed to evaluate feasibility and acceptability of a hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia.BackgroundMany youth with chronic migraine have co-occurring insomnia. Little research has been conducted to evaluate behavioral treatments for insomnia in youth with migraine.Design and methodsWe conducted a single-arm pilot trial to evaluate the feasibility and acceptability of delivering cognitive-behavioral therapy for insomnia to 21 youth (mean age 15.5, standard deviation 1.6) with co-occurring chronic migraine and insomnia. Adolescents completed up to 6 individual treatment sessions over 6 to 12 weeks, and 1 booster session 1 month later. Assessments included a prospective 7-day headache and sleep diary, and self-report measures of insomnia, sleep quality, sleep habits, and activity limitations at pre-treatment, immediate post-treatment, and 3-month follow-up.ResultsAdolescents demonstrated good treatment adherence and families rated the intervention as highly acceptable. Preliminary analyses indicated improvements from pre-treatment to post-treatment in primary outcomes of headache days (M = 4.7, SD = 2.1 vs M = 2.8, SD = 2.7) and insomnia symptoms (M = 16.9, SD = 5.2 vs M = 9.5, SD = 6.2), which were maintained at 3-month follow-up (M = 2.7, SD = 2.8; M = 9.3, SD = 5.0, respectively). We also found improvements in secondary outcomes of pain-related activity limitations as well as sleep quality, sleep hygiene, and sleep patterns.ConclusionsThese preliminary data indicate that hybrid cognitive-behavioral therapy is feasible and acceptable for youth with co-occurring chronic migraine and insomnia. Future randomized controlled trials are needed to test treatment efficacy on migraine, sleep, and functional outcomes. ClinicalTrials.gov Identifier: NCT03137147.
| S-EPMC6116549 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.MethodsRandomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05.ResultsBetween May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group.ConclusionCognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy.Clinical trial registrationClinicalTrials.gov, NCT01846585.
| S-EPMC6485299 | biostudies-literature
Project description:BackgroundInternet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.ObjectiveThis study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.MethodsThis study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.ResultsOf the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.ConclusionsAdolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.Trial registrationClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.
| S-EPMC7414416 | biostudies-literature
Project description:BackgroundDepression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages.ObjectiveThis project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression.MethodsIndividuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed.ResultsThere were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.ConclusionsThe research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.Trial registrationISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709.International registered report identifier (irrid)RR2-10.1186/s13063-016-1336-y.
| S-EPMC8895278 | biostudies-literature
Project description:Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy.ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).
| S-EPMC9016697 | biostudies-literature