Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy.

STUDY OBJECTIVES: Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity. METHODS: Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33. RESULTS: Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was -2.8 (95% CI: -4.8 to -0.8; p = 0.007, Cohen's d = 0.7), and -4.6 at week 9 (95% CI -6.6 to -2.7; p < 0.001), Cohen's d = 1.2. CONCLUSIONS: At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.

Digital cognitive-behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial.

INTRODUCTION: Insomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive-behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics. METHODS AND ANALYSIS: A parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned. ETHICS AND DISSEMINATION: The study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04621643); Pre-results.

Interpersonal problems as a predictor of pain catastrophizing in patients with chronic pain.

Background and aims Pain catastrophizing has consistently been related to a variety of negative outcomes within chronic pain conditions, but competing models exist explaining the role of catastrophizing. According to the fear-avoidance model (FAM), catastrophizing is primarily related to the appraisal of pain (i.e. "intrapersonal"), whereas the communal coping model (CCM) suggests that catastrophizing is a strategy to elicit support (i.e. "interpersonal"). In order to examine the interpersonal nature of catastrophizing, this cross-sectional study examined interpersonal problems as a predictor of pain catastrophizing in a sample of patients (n = 97) with chronic pain. Methods Self-report data was taken from patients entering a multidisciplinary, inpatient rehabilitation program. The four quadrants of the Inventory of Interpersonal Problems circumplex model (Hostile-Dominant, Hostile-Submissive, Friendly-Submissive, Friendly-Dominant) were used as predictors of pain catastrophizing in a series of separate, hierarchical regression analyses. Results After controlling for relevant confounding variables such as demographics (gender, age), pain severity, psychiatric symptoms (anxiety/depression, fatigue, insomnia), adverse life experiences and perceived social support, higher levels of Hostile-Dominant interpersonal problems predicted higher levels of pain catastrophizing (p ≤ 0.01, d = 0.56). Conclusions The results add support to the notion that pain catastrophizing may serve a communicative functioning, as predicted by the CCM, with cold, dominant and controlling behaviors as a maladaptive interpersonal strategy to elicit support. It may thus be useful to consider the broader interpersonal context of the individual, and not only the patient's appraisal of pain, when conceptualizing the role of pain catastrophizing in patients with chronic pain. Implications Future psychosocial research and treatment of chronic pain could be informed by including interpersonal theory as a useful theoretical framework, which may help shed more light on how interpersonal problems relates to pain catastrophizing.

Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep.

INTRODUCTION: Insomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions. METHODS AND ANALYSIS: A parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2 years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition. ETHICS AND DISSEMINATION: The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations. TRIAL REGISTRATION NUMBER: NCT02558647; Pre-results.

Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation.

Purpose Transfer from on-site rehabilitation to the participant's daily environment is considered a weak link in the rehabilitation chain. The main objective of this study is to see if adding boosted telephone follow-up directly after completing an occupational rehabilitation program effects work participation. Methods A randomized controlled study included participants with chronic pain, chronic fatigue or common mental disorders on long-term sick leave. After completing 3½ weeks of acceptance and commitment therapy based occupational rehabilitation, participants were randomized to boosted follow-up or a control group before returning to their daily environment. The intervention was delivered over 6 months by on-site RTW coordinators mainly via telephone. Primary outcome was RTW categorized as participation in competitive work ≥1 day per week on average over 8 weeks. Results There were 213 participants of mean age 42 years old. Main diagnoses of sick leave certification were mental disorders (38%) and musculoskeletal disorders (30%). One year after discharge the intervention group had 87% increased odds (OR 1.87, 95% confidence interval 1.06-3.31, p = 0.031), of (re)entry to competitive work ≥1 day per week compared with the controls, with similar positive results for sensitivity analysis of participation half time (≥2.5 days per week). The cost of boosted follow-up was 390.5 EUR per participant. Conclusion Participants receiving boosted RTW follow-up had higher (re)entry to competitive work ≥1 day per week at 1 year when compared to the control group. Adding low-cost boosted follow-up by telephone after completing an occupational rehabilitation program augmented the effect on return-to-work.

Factor analysis of the Achievement of Therapeutic Objectives Scale (ATOS) in short-term dynamic psychotherapy and cognitive therapy.

This study examined the factor structure of the Achievement of Therapeutic Objectives Scale (ATOS; McCullough, Larsen, et al., 2003) in short-term dynamic psychotherapy (STDP) and cognitive therapy (CT). The ATOS is a process scale that has shown promise as a measure of patients' achievements of treatment objectives in STDP and CT and is conceptualized as comprising 7 subscales hypothesized to cluster according to 3 main treatment objectives (defense restructuring, affect restructuring, and restructuring of sense of self and others). However, the factor structure of the ATOS has not been examined empirically previously. Data were derived from ratings of videotaped therapy sessions from a randomized controlled trial, comparing STDP and CT for patients with Cluster C personality disorders. The model fit of a 2- and 3-factor solution was examined in the combined patient sample, as well as in each treatment separately, utilizing structural equation modeling. Both a 2- and 3-factor model provided acceptable fit to the data. The results add to the psychometric soundness of the ATOS as an innovative observer-based instrument for examining process in STDP and CT.

The relationship between insight gained during therapy and long-term outcome in short-term dynamic psychotherapy and cognitive therapy for cluster C personality disorders.

This study examined whether 49 patients from a randomized controlled trial developed insight during therapy and whether insight predicted long-term outcome in short-term dynamic psychotherapy (STDP) and cognitive therapy (CT) for Cluster C personality disorders. Videotaped sessions early and late in treatment were analyzed using the Achievement of Therapeutic Objectives Scale. Patients' level of insight increased significantly during STDP but not CT. After controlling for early symptom change and early insight, insight near the end of therapy predicted improvement of symptom severity and interpersonal functioning during a 2-year follow-up period. These results support the theoretical assumption that insight may be a factor in the change process, central to STDP. Within CT, gain of insight did not predict long-term improvement.

Cognitive-behavioural treatment of chronic pain conditions.

The aim of this article is to present two learning-based models for chronic pain, which have been found to be effective in the treatment of various chronic pain conditions. The article intends to give an introduction to the understanding of chronic pain conditions and the mechanisms thought to influence both the transition from acute to chronic pain and the maintenance of the condition. The emphasis will be on theoretical conceptualization and practical guidelines concerning the treatment principles. Some recommendations for future research areas will be presented in the concluding notes.