Manual‐guided cognitive–behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial

Chronic insomnia is a prevalent problem in primary health care and tends to be more serious than insomnia in the general population. These patients often obtain little benefit from hypnotics, and are frequently open to exploring various options for medical treatment. However, most general practitioners (GPs) are unable to provide such options. Several meta‐analyses have shown that cognitive–behavioural therapy (CBT) for insomnia results in solid improvements on sleep parameters, and a few studies have demonstrated promising results for nurse‐administered CBT in primary care. The aim of this randomized controlled study was to investigate the clinical effectiveness of manual‐guided CBT for insomnia delivered by ordinary primary care personnel in general medical practice with unselected patients. Sixty‐six primary care patients with insomnia were randomized to CBT or a waiting‐list control group. The CBT group improved significantly more than the control group using the Insomnia Severity Index as the outcome. The effect size was high. Sleep diaries showed a significant, medium‐sized treatment effect for sleep onset latency and wake time after sleep onset. However, for all measures there is a marked deterioration at follow‐up assessments. Almost half of the treated subjects (47%) reported a clinically relevant treatment effect directly after treatment. It is concluded that this way of delivering treatment may be cost‐effective.     

Subjective–objective sleep discrepancy in patients with insomnia during and after cognitive behavioural therapy: An actigraphy study

Although patients with insomnia often show a discrepancy between self‐reported and objective sleep parameters, the role of and change in this phenomenon during treatment remain unclear. The present study aimed to assess the effect of cognitive behavioural therapy for insomnia on subjective and objective sleep discrepancy of total sleep time, sleep‐onset latency and wake after sleep onset. The total sleep time discrepancy was also assessed across the entire therapy. The second aim was to examine the treatment outcome of two insomnia groups differing in sleep perception. Thirty‐six adults with insomnia (mean age = 46.7 years, SD = 13.9; 22 females) were enrolled in the final analyses. Patients underwent a 6‐week group cognitive behavioural therapy for insomnia programme. Sleep diary and actigraphy measurements were obtained during the therapy. Patients who underestimated total sleep time (n = 16; underestimating group) were compared with patients who accurately perceived or overestimated total sleep time (n = 20; accurate/overestimating group). After cognitive behavioural therapy for insomnia, a significant decrease of total sleep time and sleep‐onset latency discrepancy was observed without a change in wake after sleep onset discrepancy in the total sample. Only the underestimating group reported decreased sleep‐onset latency discrepancy after the treatment, whereas total sleep time discrepancy significantly changed in both groups. The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4. In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different therapeutic components could play important roles in each group. components could play important roles in each group.     

Internet‐based treatment for social phobia: a randomized controlled trial

In this study conducted in the French‐speaking part of Switzerland, 52 individuals with social phobia were randomly assigned either to an Internet‐based cognitive–behavioral treatment with minimal contact with therapists via e‐mail or to a waiting‐list control group. Significant differences between the two groups were found at posttreatment on all primary outcome measures (social anxiety measures) and on two of the secondary outcome measures (general symptomatology, therapy goal attainment). On average, within‐groups effect sizes were large for the primary outcomes (Cohen's d=0.82) and for secondary outcomes (Cohen's d=1.04). Moreover, subjects in the treatment group fulfilled the criteria of clinically significant improvement significantly more often than subjects in the control group on all measured dimensions (58% vs. 20%). Users' acceptance of the program was high. The results from the present study lend further support to the hypothesis that Internet‐delivered interventions with minimal therapist contact are a promising treatment approach to social phobia. © 2009 Wiley Periodicals, Inc. J Clin Psychol 65:1–15, 2009.     

Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy

Objectives

Posttraumatic stress disorder (PTSD) is associated with sleep disturbances including insomnia and nightmares. This study compared cognitive behavioral therapy for insomnia (CBT-I) with CBT-I combined with imagery rehearsal therapy (IRT) for nightmares to evaluate if the combined treatment led to greater reductions in trauma-related sleep disturbances in Australian veterans.

Methods

Veterans with diagnosed PTSD, high insomnia symptom severity, and nightmares (N = 31) were randomized to eight group CBT-I sessions or eight group CBT-I + IRT sessions. Self-reported sleep, nightmare, and psychological measures (primary outcome: Pittsburgh Sleep Quality Index), and objective actigraphy data were collected; the effect of obstructive sleep apnea (OSA) risk on treatment outcomes was also examined.

Results

No treatment condition effects were detected for the combined treatment compared to CBT-I alone, and no moderating effect of OSA risk was detected. On average, participants from both groups improved on various self-report measures over time (baseline to 3 months posttreatment). Despite the improvements, mean scores for sleep-specific measures remained indicative of poor sleep quality. There were also no significant differences between the groups on the actigraphy indices.

Conclusions

The findings indicate that there is potential to optimize both treatments for veterans with trauma-related sleep disturbances.     

Effects of cognitive behavioural therapy on verbal learning and memory in major depression: Results of a randomized controlled trial

Major depression (MD) is often accompanied by deficits in cognitive functioning. Cognitive behavioural therapy (CBT) has beneficial effects on MD. The aim of this study was to examine whether CBT affects verbal learning and memory in patients with MD and whether CBT that emphasizes exercise during behavioural activation has additional effects on verbal performance. Ninety‐eight patients with MD were randomly assigned to CBT emphasizing either exercise during behavioural activation (CBT‐E) or CBT emphasizing pleasurable low‐energy activities (CBT‐C). A passive waiting list control group was also involved (WL). Thirty nondepressed age‐ and sex‐matched controls were included to examine potential verbal learning and memory alterations in MD at baseline. Neuropsychological measures were assessed at baseline and after 16 weeks of CBT and waiting time, respectively. Patients with MD demonstrated worse cognitive performance than healthy controls in verbal learning, recognition, and memory at baseline. After treatment, we found no improvements concerning verbal learning and memory performance compared with WL, with the exception of recognition memory. No differences were found between CBT conditions. Psychological treatments such as CBT seem to have limited influence on memory functions. Concerning recognition memory, our results contradict, in part, previous assumptions that cognitive impairments persists despite depressive symptom reduction.     

Sleep problems in children with autism spectrum disorders, developmental delays, and typical development: a population-based study

This study compared parent-reported sleep characteristics in 2- to 5-year-old children with autism spectrum disorders (ASD) to children with other developmental delays (DD) and typical development (TD). We included 529 children (303 ASD [167 males], 63 DD [46 males], and 163 TD [134 males]) enrolled in the CHARGE study, an ongoing population-based case-control study. The mean age of participants was 3.6 years (standard deviation, 0.8 years). ASD diagnosis was confirmed with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedules (ADOS). Cognitive and adaptive functioning was assessed using Mullen Scales of Early Learning (MSEL) and Vineland Adaptive Behavior Scales (VABS), respectively. Demographic, medical and sleep history information were ascertained from California birth records, telephone interview, medical assessments at clinic visit, and parent-administered questionnaires. Fifty-three percent of children with ASD had at least one frequent sleep problem, followed by 46% of children with DD, and 32% of the TD group (P < 0.0001). Exploratory factor analyses of sleep history data yielded two factors: sleep onset problems and night waking. Children with ASD had marginally higher sleep onset factor scores and significantly higher night waking factor scores compared with the TD group. Factor scores for children with DD were intermediate between the ASD and TD groups. Cognitive or adaptive development did not predict severity of sleep problems in the ASD group.     

An open‐ended primary‐care group intervention for insomnia based on a self‐help book – A randomized controlled trial and 4‐year follow‐up

Chronic insomnia is a common and burdensome problem for patients seeking primary care. Cognitive behavioural therapy has been shown to be effective for insomnia, also when presented with co‐morbidities, but access to sleep therapists is limited. Group‐treatment and self‐administered treatment via self‐help books have both been shown to be efficacious treatment options, and the present study aimed to evaluate the effect of an open‐ended group intervention based on a self‐help book for insomnia, adapted to fit a primary‐care setting. Forty primary‐care patients with insomnia (mean age 55 years, 80% women) were randomized to the open‐ended group intervention based on a cognitive behavioural therapy for insomnia self‐help book or to a care as usual/wait‐list control condition. Results show high attendance to group sessions and high treatment satisfaction. Participants in the control group later received the self‐help book, but without the group intervention. The book‐based group treatment resulted in significantly improved insomnia severity, as well as shorter sleep‐onset latency, less wake time after sleep onset, and less use of sleep medication compared with treatment as usual. The improvements were sustained at a 4‐year follow‐up assessment. A secondary analysis found a significant advantage of the combination of the book and the open‐ended group intervention compared with when the initial control group later used only the self‐help book. An open‐ended treatment group based on a self‐help book for insomnia thus seems to be an effective and feasible intervention for chronic insomnia in primary‐care settings.     

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-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 noninferiority 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).MethodsA 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 more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was 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.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Cognitive behavioural therapy for insomnia does not appear to have a substantial impact on early markers of cardiovascular disease: A preliminary randomized controlled trial

According to the World Health Organization, cardiovascular diseases are the leading cause of death in the world. Therefore, early prevention of these diseases is a public health priority. Epidemiological data suggest that insomnia may be a modifiable risk factor for cardiovascular diseases. A randomized controlled trial in a sample of insomnia patients without cardiovascular disease was conducted to investigate the effects of insomnia treatment on early markers of cardiovascular diseases assessed by 24‐hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples. Forty‐six patients with insomnia disorder were randomized to cognitive behavioural therapy for insomnia (CBT‐I; n = 23) or a waitlist control condition (n = 23). Contrary to the hypothesis, intention‐to‐treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0–0.6) despite successful insomnia treatment (d = 1.3). Potential methodological and conceptual reasons for these negative findings are discussed. Future studies might include larger sample sizes that are at risk of cardiovascular diseases and focus on other cardiovascular markers.     

Telehealth‐delivered CBT‐I programme enhanced by acceptance and commitment therapy for insomnia and hypnotic dependence: A pilot randomized controlled trial

Cognitive behavioural therapy for insomnia is the recommended treatment for chronic insomnia. However, up to a quarter of patients dropout from cognitive behavioural therapy for insomnia programmes. Acceptance, mindfulness and values‐based actions may constitute complementary therapeutic tools to cognitive behavioural therapy for insomnia. The current study sought to evaluate the efficacy of a remotely delivered programme combining the main components of cognitive behavioural therapy for insomnia (sleep restriction and stimulus control) with the third‐wave cognitive behavioural therapy acceptance and commitment therapy in adults with chronic insomnia and hypnotic dependence on insomnia symptoms and quality of life. Thirty‐two participants were enrolled in a pilot randomized controlled trial: half of them were assigned to a 3‐month waiting list before receiving the four “acceptance and commitment therapy‐enhanced cognitive behavioural therapy for insomnia” treatment sessions using videoconference. The primary outcome was sleep quality as measured by the Insomnia Severity Index and the Pittsburgh Sleep Quality Index. All participants also filled out questionnaires about quality of life, use of hypnotics, depression and anxiety, acceptance, mindfulness, thought suppression, as well as a sleep diary at baseline, post‐treatment and 6‐month follow‐up. A large effect size was found for Insomnia Severity Index and Pittsburgh Sleep Quality Index, but also daytime improvements, with increased quality of life and acceptance at post‐treatment endpoint in acceptance and commitment therapy‐enhanced cognitive behavioural therapy for insomnia participants. Improvement in Insomnia Severity Index and Pittsburgh Sleep Quality Index was maintained at the 6‐month follow‐up. Wait‐list participants increased their use of hypnotics, whereas acceptance and commitment therapy‐enhanced cognitive behavioural therapy for insomnia participants evidenced reduced use of them. This pilot study suggests that web‐based cognitive behavioural therapy for insomnia incorporating acceptance and commitment therapy processes may be an efficient option to treat chronic insomnia and hypnotic dependence.     

Gabapentin acutely increases the apnea–hypopnea index in older men: data from a randomized,double‐blind,placebo‐controlled study

Although drugs with sedative properties may increase the risk of airway collapse during sleep, their acute effects on the apnea–hypopnea index in older adults are under‐reported. We investigated the acute effects of gabapentin (GABA) on sleep breathing in older men without sleep apnea. A double‐blind, randomized, placebo‐controlled cross‐over pilot study using a bedtime dose of gabapentin 300 mg was conducted in eight non‐obese older men. Polysomnography measured the effects of the intervention. The apnea–hypopnea index was higher in the gabapentin arm than in the placebo arm (22.4 ± 6.1 versus 12.2 ± 4.3, P ≤ 0.05, d: 0.67), as was the oxygen desaturation index (20.6 ± 5.8 versus 10.8 ± 3.9, P ≤ 0.05, d: 0.68). The number needed to harm was four. A subset analysis demonstrated that differences in sleep respiratory parameters were present only during non‐rapid eye movement sleep, as well as only in the supine position. No adverse events were reported. Hence, gabapentin worsened sleep breathing acutely compared with placebo. Long‐term clinical trials are warranted to elucidate the clinical relevance of these findings for the safety profile of GABAergic agents.     

Blackcurrant seed oil for prevention of atopic dermatitis in newborns: a randomized,double‐blind,placebo‐controlled trial

Background The present increased incidence of atopic diseases has been associated with an altered intake of essential fatty acids (EFAs). The composition of blackcurrant seed oil (BCSO) corresponds to the recommended dietary intake of EFAs, and as a dietary supplement could, in small doses, modify the imbalance of EFAs in an efficient way. Objective To assess the effect of dietary supplementation with BCSO on the prevalence of atopy at 12 months of age. Methods Three hundred and thirteen pregnant mothers were randomly assigned to receive BCSO (151) or olive oil as placebo (162). The first doses were administered at 8th–16th weeks of pregnancy and were continued until the cessation of breastfeeding, followed by supplementation to the infants until the age of 2 years. Atopic dermatitis and its severity (SCORAD index) were evaluated, serum total IgE was measured and skin tests were performed at the age of 3, 12 and 24 months. Results Parental atopy was common (81.7%) among study subjects, making them infants with increased atopy risk. There was a significantly lower prevalence of atopic dermatitis in the BCSO group than in the olive oil group at the age of 12 months (33.0% vs. 47.3%, P=0.035). SCORAD was also lower in the BCSO group than in the olive oil group at 12 months of age (P=0.035). No significant differences in the prevalence of atopic dermatitis were observed between the groups at the age of 24 months (P=0.18). Conclusion Dietary supplementation with BCSO was well tolerated and it transiently reduced the prevalence of atopic dermatitis. It could therefore be one potential tool in the prevention of atopic symptoms when used at an early stage of life. (Registration number SRCTN14869647, http://www.controlled‐trials.com ) Cite this as: P. Linnamaa, J. Savolainen, L. Koulu, S. Tuomasjukka, H. Kallio, B. Yang, T. Vahlberg and R. Tahvonen, Clinical & Experimental Allergy, 2010 (40) 1247–1255.     

Web-based cognitive behavior therapy for depression with and without telephone tracking in a national helpline: secondary outcomes from a randomized controlled trial

Background

An earlier report indicated that callers to a telephone counseling service benefited from the addition of an evidence-based Web intervention for depression. It is not known whether the Web intervention would also lower alcohol use and stigma, or improve quality of life and knowledge of depression and its treatments.

Objective

To report the secondary outcomes of a trial of a Web-based cognitive behavior therapy (CBT) intervention for depression, including hazardous alcohol use, quality of life, stigma, depression literacy, and CBT literacy.

Methods

We recruited a sample of 155 callers to Lifeline, a national telephone counseling service in Australia, who met the criteria for moderate to high psychological distress. Participants were randomly assigned to 1 of 4 conditions: (1) Web CBT plus weekly telephone tracking, (2) Web CBT only, (3) weekly telephone tracking only, and (4) neither Web CBT nor telephone tracking. Participants were assessed at preintervention, postintervention, and 6 and 12 months postintervention.

Results

At postintervention, participants who completed the Web intervention either with or without telephone support had lower levels of hazardous alcohol use (without tracking: P = .008, effect size = 0.23; with tracking: P = .003, effect size = 0.26), improved quality of life (without tracking: P = .001, effect size = 0.81; with tracking: P = .009, effect size = 0.63), and improved CBT literacy (without tracking: P = .01, effect size = 0.71; with tracking: P < .001, effect size = 0.80) compared with those who did not receive the Web intervention or telephone support. Results for quality of life and CBT literacy were maintained at 6- and 12-month’s follow-up, but differences in hazardous alcohol use were not significantly different between conditions at 6 and 12 months. Although omnibus tests for depression literacy and stigma were nonsignificant, contrasts revealed that those in the Web-only condition showed significantly lower levels of stigma than participants in the control condition at postintervention. This was true for participants in the Web-only and Web plus tracking conditions at 6 months. Similarly, those in the Web-only and Web plus tracking conditions had significantly higher depression literacy at postintervention, and this was maintained in the Web-only condition at 6-months’ follow-up. No significant differences were found in depression literacy and stigma between conditions at 12 months.

Conclusions

Evidence-based Web interventions for depression can be effective not only in reducing depression symptoms but also in improving other health outcomes, including quality of life, hazardous alcohol use, and knowledge about effective strategies for depression self-management.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 93903959; http://www.controlled-trials.com/ISRCTN93903959/ (Archived by WebCite at http://www.webcitation.org/65y61nSsH)