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Insomnia and depression are clearly interrelated. Several studies showed that treating insomnia with cognitive behavioural therapy positively affects concurrent depressive symptoms. However, it is unclear what treatment component is responsible for the change in depressive symptoms.
To develop the evidence base we employed a case series design in which we administered a single component sleep restriction treatment to individuals with both insomnia and depressive symptoms.
Seven patients were included, of whom six completed the intervention. Patients completed weekly assessments during the 4-week wait period and 6-week treatment phase.
At the post-assessment, two out of six patients showed clinical improvement in depressive symptoms. All six patients showed clinically meaningful improvement at the 3-month follow-up assessment, and two patients had maintained gains at 6-month follow-up.
This case series study shows that, especially at 3-month follow-up, sleep restriction therapy is associated with clinically relevant treatment gains in patients with both insomnia and depressive symptoms.
Like any therapy, acupuncture is effective for some patients, while not helpful for others. Understanding from a patients' perspective what makes one respond or not to acupuncture can help guide further intervention development. This study aimed to identify factors that influence the perception of acupuncture's therapeutic effect among cancer survivors with insomnia.
We conducted post-treatment semi-structured interviews with cancer survivors who were randomized to the acupuncture group in a clinical trial for the treatment of insomnia. Survivors were categorized into Responders and Non-Responders to acupuncture treatment based on the change in the Insomnia Severity Index with a reduction of eight points or greater as the cut-off for the response. An integrated approach to data analysis was utilized by merging an a priori set of codes derived from the key ideas and a set of codes that emerged from the data through a grounded theory approach. Codes were examined for themes and patterns.
Among 28 cancer survivors interviewed, 18 (64%) were classified as Responders. Participants perceived the ability to respond to acupuncture as dependent on treatment that effectively: (1) alleviated co-morbidities contributing to insomnia, (2) supported sleep hygiene practices, and (3) provided a durable therapeutic effect. Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture.
Significance of results
We identified patient-perceived contributors to response to acupuncture, such as co-morbid medical conditions, adequate support for sleep hygiene practices, and temporary therapeutic relief. Addressing these factors may improve the overall effectiveness of acupuncture for insomnia.
The objectives of this study were to validate the Patient Empowerment Strategies Questionnaire (PES-Q) in a Greek sample and to study its psychometric properties in a sample of patients diagnosed with chronic insomnia.
This is a validation of the PES-Q in Attikon General Hospital, School of Medicine, National and Kapodistrian University of Athens. The questionnaire was administered to 93 subjects aged between 18 and 85 years (mean age ± SD: 54.7 ± 15.2, 28% males).
The criterion validity of the questionnaire was tested with the use of four specific criteria: the Athens Insomnia Scale, the Pittsburg questionnaire (Pittsburg Sleep Quality Index), the Depression, Anxiety and Stress Scale, and the Self-Esteem Scale.
According to factor analysis results, the structure of the original scale was confirmed by the presence of one main factor in the Greek sample, explaining 40.1% of the variance of PES-Q queries. The questionnaire showed satisfactory reliability (Cronbach’s α = 0.887). The results of the current study suggest that the PES-Q may be used as an accurate psychometric instrument for the purposes of chronic insomnia. Future research should examine the psychometric qualities of the PES-Q Greek version in a larger sample.
Cognitive behaviour therapy for insomnia (CBTi) has emerged as the first-line treatment for insomnia where available. Clinical trials of digital CBTi (dCBTi) have demonstrated similar efficacy and drop-out rates to face-to-face CBTi. Most patients entering clinical trials are carefully screened to exclude other sleep disorders. This is a case series review of all those referred to a dCBTi within an 18-month time period. Those initially screened, accepted after exclusion of other sleep disorders, commencing and completing therapy were assessed to understand patient population referred from general practice in the UK. 390 patient referrals were analysed. 135 were suitable for dCBTi with a high rate of other sleep disorders detected in screening. 78 completed therapy (20.0%) and 44.9% had significant improvement in sleep outcomes, achieving ≥20% improvement in final sleep efficiency. dCBTi can be used within the UK NHS with good benefit for those who are selected as having insomnia and who then complete therapy. Many referrals are made with those likely to have distinct primary sleep disorders highlighting the need for education regarding sleep and sleep disorders prior to dCBTi therapy.
Key learning aims
(1)The use of unsupported digital cognitive behavioural therapy for insomnia (dCBTi) requires proper patient selection.
(2)There are many insomnia mimics and also previously unrecognized sleep and psychiatric disturbances that are under-diagnosed in the primary care setting that are contraindications for unsupported dCBTi.
(3)The use of a stepped care approach similar to the UK’s Improving Access to Psychological Therapies (IAPT) model using dCBTi could be feasible in the public health setting.
Insomnia disorder in adolescence is prevalent, persistent and associated with adverse outcomes, including reduced quality of life. Cognitive behavioural therapy for insomnia (CBT-i) has shown promise as an effective treatment for adolescents. Recent research has highlighted the role of emotion regulation in insomnia, suggesting that the inclusion of emotion regulation techniques may enhance CBT-i.
To evaluate the feasibility and preliminary effectiveness of a CBT-i treatment program for insomnia in early adolescence, augmented with emotion regulation strategies, using a case-series design.
Three participants (mean 11.67 years) completed the program that consisted of seven, weekly individual therapy sessions and parental participation. Participants monitored their sleep daily during the intervention, and insomnia diagnostic status and severity, use of emotion regulation strategies and quality of life were assessed at baseline, post-intervention and at 6-week follow-up.
At post-treatment, none of the participants met criteria for insomnia and all reported statistically reliable reductions in symptoms. Improvements were maintained at follow-up for two participants. Sleep onset latency was reduced and improvements in quality of life were evident. There were no changes in the use of emotion regulation strategies following treatment. Adolescents and parents reported high program satisfaction.
This preliminary evaluation provides support for the effectiveness of the CBT-i program tested. However, given that emotion regulation did not change and yet improvements in sleep were evident, the usefulness of augmenting the program with emotion regulation strategies requires further evaluation.
We sought to investigate the risk of incident major depressive disorder (MDD) attributable to a range of sleep disorders in the Danish population. Data were obtained by linking longitudinal Danish population-based registers. A total of 65,739 individuals who had first onset of depression between 1995 and 2013 were selected as cases. For each case, a set of 20 controls of the same sex, birth month and year and who had not had depression by the date that the case was diagnosed were selected at random form the population (N = 1,307,580 in total). We examined whether there was an increased rate of prior sleep disorders in MDD cases compared to controls using conditional logistic regression. An increased risk of incident depression in cases was found for all sleep disorders analyzed. Highest incidence rate ratios (IRRs) were found for circadian rhythm disorders (IRR = 7.06 [2.78–17.91]) and insomnia of inorganic origin (IRR = 6.76 [4.37–10.46]). The lowest estimated IRR was for narcolepsy (IRR = 2.00 [1.26–3.17]). Those diagnosed with a sleep disorder in the last 6 months were at highest risk of developing depression compared to those with at least 1 year since diagnosis (3.10 vs. 2.36). Our results suggest that having any sleep disorder is a risk factor for incident depression. Depression screening should be considered for patients with sleep disorders, and where possible, long-term follow-up for mental health problems is advisable.
Objectives: Insomnia is associated with neuropsychological dysfunction. Evidence points to the role of nocturnal light exposure in disrupted sleep patterns, particularly blue light emitted through smartphones and computers used before bedtime. This study aimed to test whether blocking nocturnal blue light improves neuropsychological function in individuals with insomnia symptoms. Methods: This study used a randomized, placebo-controlled crossover design. Participants were randomly assigned to a 1-week intervention with amber lenses worn in wrap-around frames (to block blue light) or a 1-week intervention with clear lenses (control) and switched conditions after a 4-week washout period. Neuropsychological function was evaluated with tests from the NIH Toolbox Cognition Battery at three time points: (1) baseline (BL), (2) following the amber lenses intervention, and (3) following the clear lenses intervention. Within-subjects general linear models contrasted neuropsychological test performance following the amber lenses and clear lenses conditions with BL performance. Results: Fourteen participants (mean(standard deviation, SD): age = 46.5(11.4)) with symptoms of insomnia completed the protocol. Compared with BL, individuals performed better on the List Sorting Working Memory task after the amber lenses intervention, but similarly after the clear lenses intervention (F = 5.16; p = .014; η2 = 0.301). A similar pattern emerged on the Pattern Comparison Processing Speed test (F = 7.65; p = 0.002; η2 = 0.370). Consideration of intellectual ability indicated that treatment with amber lenses “normalized” performance on each test from approximately 1 SD below expected performance to expected performance. Conclusions: Using a randomized, placebo-controlled crossover design, we demonstrated improvement in processing speed and working memory with a nocturnal blue light blocking intervention among individuals with insomnia symptoms. (JINS, 2019, 25, 668–677)
The current study compares the measures of sleep quality and intensity of insomnia based on the clustering analysis of variables including dysfunctional beliefs and attitudes about sleep, experiential avoidance, personality traits of neuroticism, and complications with emotion regulation among the individuals struck by an earthquake in Kermanshah Province.
This study is a cross-sectional study that was carried out among earthquake victims of Kermanshah Province (western Iran) in 2017. Data were gathered starting 10 days after the earthquake and lasted for 2 weeks; of 1,200 standard questionnaires distributed, 1,001 responses were received, and the analysis was performed using 999 participants. The data analysis was carried out using a cluster analysis (K-mean method).
Two clusters were identified, and there is a significant difference between these two clusters in regard to all of the variables. The cluster with higher mean values for the selected variables shows a higher intensity of insomnia and a lower sleep quality.
Considering the current results, it can be concluded that variables of dysfunctional attitudes and beliefs about sleep, experiential avoidance, the personality traits of neuroticism, and complications with emotion regulation are able to identify the clusters where there is a significant difference in regard to sleep quality and the intensity of insomnia. (Disaster Med Public Health Preparedness. 2019;13:745–752)
Background: Insomnia has become a major public health concern. Aims: The study examined the efficacy of a web-based unguided self-help programme with automated feedback. The programme was based on cognitive behaviour therapy for insomnia (CBT-I). The investigation particularly focused on factors that contribute to the maintenance of insomnia and tested whether treatment effects were stable over a period of 12 months. Method: Fifty-six participants were randomly assigned either to web-based CBT-I or to the waiting-list control group. Included measures assessed insomnia severity, sleep-related cognitions, safety behaviours, depression, anxiety and somatization. In the intervention group, a sleep diary was used to assess sleep continuity parameters, sleep quality and daytime performance. Results: Large between- and within-group effect sizes (d = 1.79, d = 1.59) for insomnia severity were found. The treatment group effect remained stable over the period of 12 months. Further, sleep-related cognitions, safety behaviours, depression and somatization significantly decreased in the treatment group compared with the control group. On all sleep diary parameters, medium to large effects were revealed within the treatment group. Anxiety did not decrease significantly from pre- to post-assessment. For all measures except somatization and anxiety significant within-group effects were found at 12-month follow-up assessment indicating long-lasting effects. Conclusions: This study adds evidence to the literature on unguided online interventions for insomnia, and indicates that online CBT-I can have substantial long-term effects on relevant sleep-related outcome parameters. Moreover, the results indicate that sleep-related cognitions and safety behaviour can be successfully altered with an unguided CBT-I intervention.
Postural orthostatic tachycardia syndrome encompasses multiple disabling symptoms that interfere with daily activities. Non-pharmacologic approaches can be insufficient and can require adjunctive medications to manage symptoms. Minimal data exist in the literature on medication outcomes in these patients. We reviewed our database for medication management outcomes.
Materials and Methods
Patients aged 18 years and younger at initial diagnosis met the inclusion criteria. All prescribed patient medications were extracted from the electronic health record, excluding medications for unrelated symptoms or comorbid diseases. Medications were grouped by symptom class consistent with our programme utilisation protocol. Within symptom classification, therapy was deemed successful when a specific dose was prescribed at least five consecutive times without changes; this was confirmed by chart review. Individual medications and overall percentage of successful therapies within symptom classifications were assessed, with further analysis by gender. t-Test, χ2, and Mann–Whitney U-test were used to assess for differences in specific variables, as appropriate.
A total of 708 patients met the study criteria. The percentage of patients with effective therapy by symptom includes light-headedness (52.2%), headache (48.2%), nausea (39.1%), dysmotility (43.4%), pain (53.4%), and insomnia (42.8%). Insomnia therapy was better for females; all other therapies showed no gender difference. The median number of therapies prescribed per patient per symptom was 2 for light-headedness, headache, and insomnia, and 1 for nausea, dysmotility, and pain.
Symptoms associated with this disorder can be effectively managed with various medications. Further randomised studies are needed to better ascertain true efficacy compared with placebo.
Background: Recent treatment studies with cognitive behavioural therapy for insomnia (CBT-I) have demonstrated effects on both sleep problems and depression. Two previous studies have indicated that the beneficial effect from CBT-I on depression may come through improved sleep, although insomnia severity during treatment had not previously been investigated as a mediator. Aims: Our aim was to investigate if insomnia severity during treatment mediated between CBT-I and depression severity after treatment, in a sample with co-morbid insomnia and depressive symptomology. We also examined whether depressive severity during treatment mediated between CBT-I and insomnia after treatment. Method: The participants were recruited from advertisements and fulfilled criteria for insomnia diagnosis, and had depressive symptomatology (Beck Depression Inventory-second edition: BDI-II > 13). Two-thirds of the participants were diagnosed with major depressive disorder. The participants received four biweekly group sessions of CBT-I or relaxation training (active control). Insomnia severity (Insomnia Severity Index) and depressive severity (BDI-II) were measured at baseline, mid-treatment, post-treatment and 6-month follow-up. The mid-treatment measures were used as mediators. Results: Mediational analyses demonstrated a significant reciprocal relationship between insomnia severity and depressive severity throughout CBT-I, although mid-treatment insomnia had a stronger effect on depression than mid-treatment depression had on insomnia. The results were similar for both post-treatment and follow-up. Discussion: Some improvement in depressive severity after CBT-I is explained by improved sleep. The findings emphasize the importance of making comorbid insomnia a treatment focus in its own right.
Understanding the underlying mechanisms of recovery from insomnia is an important goal for improving existing treatments. In a randomised controlled trial, 57 participants with insomnia disorder were given either cognitive therapy (CT) or mindfulness-based therapy (MBT) following 4 sessions of CBT. Each participant was assessed on process measures related to CT and MBT. MBT resulted in improvement on mindfulness process measures and the size of the improvement was significantly greater than achieved in the CT condition. Interestingly, CT and MBT both resulted in significant improvement on the cognitive process measures. Treatment outcome on the primary outcome measure (Insomnia Severity Index) was not predicted by type of treatment but was predicted by posttreatment scores on the cognitive process measures. The results suggest that changes in cognitive processes are especially important in treating insomnia, and that there are different therapeutic modalities through which this can be achieved.
Insomnia and depression are highly comorbid and mutually exacerbate clinical trajectories and outcomes. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces both insomnia and depression severity, and can be delivered digitally. This could substantially increase the accessibility to CBT-I, which could reduce the health disparities related to insomnia; however, the efficacy of digital CBT-I (dCBT-I) across a range of demographic groups has not yet been adequately examined. This randomized placebo-controlled trial examined the efficacy of dCBT-I in reducing both insomnia and depression across a wide range of demographic groups.
Of 1358 individuals with insomnia randomized, a final sample of 358 were retained in the dCBT-I condition and 300 in the online sleep education condition. Severity of insomnia and depression was examined as a dependent variable. Race, socioeconomic status (SES; household income and education), gender, and age were also tested as independent moderators of treatment effects.
The dCBT-I condition yielded greater reductions in both insomnia and depression severity than sleep education, with significantly higher rates of remission following treatment. Demographic variables (i.e. income, race, sex, age, education) were not significant moderators of the treatment effects, suggesting that dCBT-I is comparably efficacious across a wide range of demographic groups. Furthermore, while differences in attrition were found based on SES, attrition did not differ between white and black participants.
Results provide evidence that the wide dissemination of dCBT-I may effectively target both insomnia and comorbid depression across a wide spectrum of the population.
Insomnia is underrecognized and inadequately managed, with close to 60% of cancer survivors experiencing insomnia at some point in the treatment trajectory. The objective of this study was to further understand predisposing, precipitating, and perpetuating factors in the development and maintenance of insomnia in cancer survivors.
A heterogeneous sample of 63 patients who had completed active treatment was recruited. Participants were required to have a score >7 on the Insomnia Severity Index and meet the diagnostic criteria for insomnia disorder. Open-ended, semistructured interviews were conducted to elicit participants’ experiences with sleep problems. An a priori set of codes and a set of codes that emerged from the data were used to analyze the data.
The mean age of the sample was 60.5 years, with 30% identifying as non-white and 59% reporting their sex as female. The cancer types represented were heterogeneous with the two most common being breast (30%) and prostate (21%). Participants described an inherited risk for insomnia, anxious temperament, and insufficient ability to relax as predisposing factors. Respondents were split as to whether they classified their cancer diagnosis as the precipitating factor for their insomnia. Participants reported several behaviors that are known to perpetuate problems with sleep including napping, using back-lit electronics before bed, and poor sleep hygiene. One of the most prominent themes identified was the use of sleeping medications. Participants reported that they were reluctant to take medication but felt that it was the only option to treat their insomnia and that it was encouraged by their doctors.
Significance of results
Insomnia is a prevalent, but highly treatable, disorder in cancer survivors. Patients and provider education is needed to change individual and organizational behaviors that contribute to the development and maintenance of insomnia and increase access to evidence-based nonpharmacological interventions.
Insomnia is effectively treated with online Cognitive Behavioral Therapy for Insomnia (CBT-I). Previous research has suggested the effects might not be limited to sleep and insomnia severity, but also apply to depressive symptoms. Results, however, are mixed.
In this randomized controlled trial we investigated the effects of guided online CBT-I on depression and insomnia in people suffering from symptoms of both. Participants (n = 104) with clinical insomnia and at least subclinical depression levels were randomized to (1) guided online CBT-I and sleep diary monitoring (i-Sleep) or (2) control group (sleep diary monitoring only). The primary outcome was the severity of depressive symptoms (Patient Health Questionnaire-9 without sleep item; PHQ-WS). Secondary outcomes were insomnia severity, sleep diary parameters, fatigue, daytime consequences of insomnia, anxiety, and perseverative thinking.
At post-test, participants in the i-Sleep condition reported significantly less depressive symptoms (PHQ-WS) compared with participants in the sleep-diary condition (d = 0.76). Large significant effects were also observed for insomnia severity (d = 2.36), most sleep diary parameters, daytime consequences of insomnia, anxiety, and perseverative thinking. Effects were maintained at 3 and 6 month follow-up. We did not find significant post-test effects on fatigue or total sleep time.
Findings indicate that guided online CBT-I is not only effective for insomnia complaints but also for depressive symptoms. The effects are large and comparable with those of depression therapy. Clinical trial registration number: NTR6049 (Netherlands Trial Register).
Background: Almost all patients admitted at acute crisis to a psychiatric ward experience clinically significant symptoms of insomnia. Ward environments pose challenges to both sleep and the delivery of therapy. Despite this, there is no description of how to adapt cognitive behavioural therapy (CBT) for insomnia to overcome these challenges. Aims: (i) To describe the key insomnia presentations observed in the Oxford Ward Sleep Solution (OWLS) trial and (ii) outline key adaptations aimed to increase accessibility and hence effectiveness of CBT for insomnia for a ward setting. Methods: Trial therapists collaboratively agreed the key insomnia presentations and therapy adaptations based on their individual reflective logs used during the trial. Results: Three key insomnia presentations are outlined. These are used to illustrate the application of 10 CBT for insomnia therapy adaptations. These include use of sleep monitoring watches to engage patients in treatment, stabilizing circadian rhythms, reducing the impact of night-time observations and managing discharge as a sleep challenge. Conclusions: Whilst inpatient wards bring challenges for sleep and therapy delivery, creative adaptations can increase the accessibility of evidence based CBT for insomnia techniques. This therapy has proven popular with patients.
Background: Cognitive behavioural therapy for insomnia (CBTI) has been successfully applied to those with chronic illness. However, despite the high prevalence of post-stroke insomnia, the applicability of CBTI for this population has not been substantially researched or routinely used in clinical practice. Aims: The present study developed a ‘CBTI+’ protocol for those with post-stroke insomnia and tested its efficacy. The protocol also incorporated additional management strategies that considered the consequences of stroke. Method: A single-case experimental design was used with five community-dwelling individuals with post-stroke insomnia. Daily sleep diaries were collected over 11 weeks, including a 2-week baseline, 7-week intervention and 2-week follow-up. The Insomnia Severity Index, Dysfunctional Attitudes and Beliefs About Sleep Scale, Epworth Sleepiness Scale, Fatigue Severity Scale and Stroke Impact Scale were administered pre- and post-treatment, as well as at 2-week follow-up. Results: At post-treatment, three participants no longer met diagnostic criteria for insomnia and all participants showed improvements on two or more sleep parameters, including sleep duration and sleep onset latency. Three participants showed a reduction in daytime sleepiness, increased quality of life and reduction in unhelpful beliefs about sleep. Conclusions: This study provides initial evidence that CBTI+ is a feasible and acceptable intervention for post-stroke insomnia. Furthermore, it indicates that sleep difficulties in community-dwelling stroke populations are at least partly maintained by unhelpful beliefs and behaviours. The development and delivery of the CBTI+ protocol has important clinical implications for managing post-stroke insomnia and highlights directions for future research.
Sick leave due to common mental disorders (CMDs) increase rapidly and present a major societal challenge. The overall effect of psychological interventions to reduce sick leave and symptoms has not been sufficiently investigated and there is a need for a systematic review and meta-analysis of the field. The aim of the present meta-analysis was to calculate the effect size of psychological interventions for CMDs on sick leave and psychiatric symptoms based on all published randomized controlled trials. Methodological quality, the risk of bias and publication bias were also assessed. The literature searches gave 2240 hits and 45 studies were included. The psychological interventions were more effective than care as usual on both reduced sick leave (g = 0.15) and symptoms (g = 0.21). There was no significant difference in effect between work focused interventions, problem-solving therapy, cognitive behavioural therapy or collaborative care. We conclude that psychological interventions are more effective than care as usual to reduce sick leave and symptoms but the effect sizes are small. More research is needed on psychological interventions that evaluate effects on sick leave. Consensual measures of sick leave should be established and quality of psychotherapy for patients on sick leave should be improved.
When patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS).
This assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive–behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks. Assessments took place at 0, 2, 4 and 12 weeks. Feasibility outcomes assessed recruitment, retention of participants and uptake of the therapy. Primary efficacy outcomes were the Insomnia Severity Index and Warwick–Edinburgh Mental Wellbeing Scale at week 2. Analyses were intention-to-treat, estimating treatment effect with 95% confidence intervals.
Between October 2015 and July 2016, 40 participants were recruited (from 43 assessed eligible). All participants offered STAC completed treatment (mean sessions received = 8.6, s.d. = 1.5). All participants completed the primary end point. Compared with SC, STAC led to large effect size (ES) reductions in insomnia at week 2 (adjusted mean difference −4.6, 95% CI −7.7 to −1.4, ES −0.9), a small improvement in psychological wellbeing (adjusted mean difference 3.7, 95% CI −2.8 to 10.1, ES 0.3) and patients were discharged 8.5 days earlier. One patient in the STAC group had an adverse event, unrelated to participation.
In this challenging environment for research, the trial was feasible. Therapy uptake was high. STAC may be a highly effective treatment for sleep disturbance on wards with potential wider benefits on wellbeing and admission length.
Common mental disorders (CMD) cause large suffering and high societal costs. Cognitive behavioural therapy (CBT) can effectively treat CMD, but access to treatment is insufficient. Guided self-help (GSH) CBT, has shown effects comparable with face-to-face CBT. However, not all patients respond to GSH, and stepping up non-responders to face-to-face CBT, could yield larger response rates. The aim was to test a stepped care model for CMD in primary care by first evaluating the effects of GSH-CBT and secondly, for non-responders, evaluating the additional effect of face-to-face CBT.
Consecutive patients (N = 396) with a principal disorder of depression, anxiety, insomnia, adjustment or exhaustion disorder were included. In Step I, all patients received GSH-CBT. In Step II, non-responders were randomized to face-to-face CBT or continued GSH. The primary outcome was remission status, defined as a score below a pre-established cutoff on a validated disorder-specific scale.
After GSH-CBT in Step I, 40% of patients were in remission. After Step II, 39% of patients following face-to-face CBT were in remission compared with 19% of patients after continued GSH (p = 0.004). Using this stepped care model required less than six therapy sessions per patient and led to an overall remission rate of 63%.
Stepped care can be effective and resource-efficient to treat CMD in primary care, leading to high remission rates with limited therapist resources. Face-to-face CBT speeded up recovery compared with continued GSH. At follow-ups after 6 and 12 months, remission rates were similar in the two groups.