Association between expectations and clinical outcomes in online v. face-to-face therapy - an individual participant data meta-analysis.

BACKGROUND: Online treatments are increasing in number and are currently available for a wide range of clinical problems. To date little is known about the role of treatment expectations and other placebo-like mechanisms in online settings compared to traditional face-to-face treatment. To address this knowledge gap, we analyzed individual participant data from randomized clinical trials that compared online and face-to-face psychological interventions. METHODS: MEDLINE (Ovid) and PsycINFO (Ovid) were last searched on 2 February 2021. Randomized clinical trials of therapist guided online v. face-to-face psychological interventions for psychiatric or somatic conditions using a randomized controlled design were included. Titles, abstracts, and full texts of studies were independently screened by multiple observers. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was followed. Authors of the matching trials were contacted for individual participant data. Ratings from the Credibility and Expectancy Questionnaire and the primary outcome measure from each trial were used to estimate the association between expectation ratings and treatment outcomes in online v. face-to-face interventions, using a mixed-effects model. RESULTS: Of 7045 screened studies, 62 full-text articles were retrieved whereof six studies fulfilled the criteria and provided individual participant data (n = 491). Overall, CEQ ratings predicted clinical outcomes (ß = 0.27) at end of treatment with no moderating effect of treatment modality (online v. face-to-face). CONCLUSIONS: Online treatment appears to be equally susceptible to expectancy effects as face-to-face therapy. This furthers our understanding of the importance of placebo-like factors in online treatment and may aid the improvement of healthcare in online settings.

Psychological Treatment of Comorbid Insomnia and Depression: A Double-Blind Randomized Placebo-Controlled Trial.

INTRODUCTION: Insomnia and depression are highly prevalent disorders and commonly occur together. Cognitive behavioral therapy for insomnia, CBT-I, has been shown to be effective in treating insomnia and also comorbid depression. However, it is unclear whether effects of CBT-I on depression are specific or nonspecific. Also, depressive symptoms often remain too high after CBT-I, indicating a need for improved treatments. The objective was to determine whether combining CBT-I with CBT for depression, without increasing treatment length, reduces both insomnia and depression more than CBT for depression with a placebo insomnia intervention. METHODS: A 12-week double-blind randomized controlled trial with a 6-month follow-up in a psychiatric setting using therapist-guided internet-delivered treatments was conducted. Patients (N = 126) were diagnosed with insomnia disorder and major depression by physicians. Primary outcome measures were as follows: self-rating scales Insomnia Severity Index (ISI) and Montgomery-Åsberg Depression Rating Scale (MADRS-S). RESULTS: The combined treatment showed specific effects on insomnia severity over the control treatment (p = 0.007) but was not more effective in reducing depression severity. Within-group effects (Cohen's d) at post and at 6 months were as follows: ISI 1.40 and 1.42 (combined treatment), 0.95 and 1.00 (control); MADRS-S 0.97 and 1.12 (combined), 0.88 and 0.89 (control). CONCLUSIONS: CBT-I shows large specific effects on insomnia severity and is superior to control in this regard. Both treatments had similar effects on depression severity, i.e., combining CBT-I with CBT for depression did not enhance outcomes on depression compared to control. We suggest CBT-I should always be offered to patients with insomnia and depression comorbidity, possibly as the first-hand choice. Combining it with a psychological treatment for depression could be too burdening and may not be beneficial.

The effect of psychosocial interventions for sexual health in patients with pelvic cancer: a systematic review and meta-analysis.

AIM: The aim of this systematic review and meta-analysis was to explore and evaluate the effect of psychosocial interventions in improving sexual health outcomes among post-treatment patients with pelvic cancer. METHODS: Inclusion and exclusion criteria were pelvic cancer survivors; psychosocial interventions; studies with a control group and measures of sexual health. Five databases were searched for literature along with an inspection of the included studies' reference lists to extend the search. Risk of bias was assessed with the RoB2 tool. Standardised mean difference (SMD) with a random effects model was used to determine the effect size of psychosocial interventions for sexual health in patients with pelvic cancers. RESULTS: Thirteen studies were included, with a total number of 1,541 participants. There was a large heterogeneity regarding the type of psychosocial intervention used with the source found in a leave one out analysis. Six studies showed statistically significant improvements in sexual health, while three showed positive but non-significant effects. The summary effect size estimate was small SMD = 0.24 (95% confidence interval [CI]: 0.05 to 0.42, p = 0.01). DISCUSSION: There is limited research on psychosocial interventions for sexual health in pelvic cancer patients. There are also limitations in the different pelvic cancer diagnoses examined. Commonly, the included articles examined physical function rather than the whole sexual health spectrum. The small effect sizes may in part be due to evaluation of psychosocial interventions by measuring physical dysfunction. Future research should broaden sexual health assessment tools and expand investigations to more cancer types.

Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental or Injection Phobia: Randomized Controlled Trial.

BACKGROUND: Dental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking. OBJECTIVE: This randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment. METHODS: We enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires. RESULTS: All participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes-dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)-as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events. CONCLUSIONS: ICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents. TRIAL REGISTRATION: ClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079.

A comparison of sleep restriction and sleep compression on objective measures of sleep: A sub-sample from a large randomised controlled trial.

Sleep restriction therapy is a central component of cognitive behavioural therapy for insomnia, but can lead to excessive sleepiness, which may impede treatment adherence. Sleep compression therapy has been suggested as a possibly gentler alternative. The aim of this study was to compare the effects of sleep restriction therapy and sleep compression therapy on objective measures of sleep, with a focus on magnitude and timing of effects. From a larger study of participants with insomnia, a sub-sample of 36 underwent polysomnographic recordings, before being randomised to either sleep restriction (n = 19) or sleep compression (n = 17) and receiving online treatment for 10 weeks. Assessments with polysomnography were also carried out after 2, 5, and 10 weeks of treatment. Data were analysed with multilevel linear mixed effect modelling. As per treatment instructions, participants in sleep restriction initially spent shorter time in bed compared with sleep compression. Participants in sleep restriction also showed an initial decrease of total sleep time, which was not seen in the sleep compression group. Both treatments led to improvements in sleep continuity variables, with a tendency for the improvements to come earlier during treatment in sleep restriction. No substantial differences were found between the two treatments 10 weeks after the treatment start. The results indicate that homeostatic sleep pressure may not be as important as a mechanism in sleep compression therapy as in sleep restriction therapy, and an investigation of other mechanisms is needed. In conclusion, the treatments led to similar changes in objective sleep at a somewhat different pace, and possibly through different mechanisms.

Treatment feasibility of a digital tool for brief self-help behavioural therapy for insomnia (FastAsleep).

Cognitive behavioural therapy for insomnia is efficacious and recommended for insomnia, but availability is scarce. Cognitive behavioural therapy for insomnia self-help interventions could increase availability, especially if unguided. Optimizing cognitive behavioural therapy for insomnia methods and system user-friendliness, we developed a short, digital, self-help programme-FastAsleep-based on the behavioural components of sleep restriction and stimulus control. This study investigated its feasibility and preliminary effects. Thirty media-recruited participants with moderate to severe insomnia were assessed via telephone before using FastAsleep for 4 weeks, and were interviewed afterwards. Self-ratings with web questionnaires were conducted at screening, pre-, mid- and post-treatment, and at 3-month follow-up. Primary outcomes were feasibility (credibility, adherence, system user-friendliness and adverse effects), and secondary outcomes were changes in symptom severity (insomnia, depression and anxiety). Adherence was generally high, participants' feasibility ratings were favourable, and adverse effects matched previously reported levels for cognitive behavioural therapy for insomnia. Symptoms of insomnia decreased after the treatment period (Hedge's g = 1.79, 95% confidence interval = 1.20-2.39), as did symptoms of depression and anxiety. FastAsleep can be considered feasible and promising for alleviating insomnia symptoms among patients fit for self-care. Future controlled trials are needed to establish the efficacy of FastAsleep and its suitability in a stepped care model.

What Predicts Treatment Adherence and Low-Risk Drinking? An Exploratory Study of Internet Interventions for Alcohol Use Disorders.

INTRODUCTION: Internet interventions for alcohol problems are effective, but not all participants are helped. Further, the importance of adherence has often been neglected in research on internet interventions for alcohol problems. Prediction analysis can help in prospectively assessing participants' probability of success, and ideally, this information could be used to tailor internet interventions to individual needs. METHODS: Data were obtained from a randomized controlled trial on internet interventions for alcohol use disorders. Twenty-nine candidate predictors were run in univariate logistic regressions with two dichotomous dependent outcomes: adherence (defined as completing at least 60% of the treatment modules) and low-risk drinking (defined as drinking within national public health guidelines) at two time points - immediately post-treatment and at the 6-month follow-up. Significant predictors were entered hierarchically into domain-specific logistic regressions. In the final models, predictors still showing significant effects were run in multiple logistic regressions. RESULTS: One predictor significantly predicted adherence: treatment credibility (as in how logical the treatment is and how successful one perceives the treatment to be) assessed during the third week of the intervention. Four predictors significantly predicted low-risk drinking at the post-treatment follow-up: pre-treatment abstinence (i.e., not drinking during the 7 days before treatment started), being of the male gender, and two personality factors - a low degree of antagonism and a high degree of alexithymia. At the 6-month follow-up, pre-treatment abstinence was the only significant predictor. CONCLUSION: Adherence was not predictive of low-risk drinking. Personality variables may have predictive value and should be studied further. Those who abstain from alcohol during the week before treatment starts have a higher likelihood of achieving low-risk drinking than people who initially continue drinking.

Primary Care Behavioral Health in Sweden - a protocol of a cluster randomized trial evaluating outcomes related to implementation, organization, and patients (KAIROS).

BACKGROUND: Providing comprehensive and continuous care for patients whose conditions have mental or behavioral components is a central challenge in primary care and an important part of improving universal health coverage. There is a great need for high and routine availability of psychological interventions, but traditional methods for delivering psychotherapy often result in low reach and long wait times. Primary Care Behavioral Health (PCBH) is a method for organizing primary care in which behavioral health staff provide brief, flexible interventions to a large part of the population in active collaboration with other providers. While PCBH holds promise in addressing important challenges, it has not yet been thoroughly evaluated. METHODS: This cluster randomized trial will assess 17 primary care centers (PCCs) that are starting a PCBH implementation process. The PCCs will be divided into two groups, with one starting immediate implementation and the other acting as a control, implementing six months later. The purpose of the study is to strengthen the evidence base for PCBH regarding implementation-, organization-, and patient-level outcomes, taking into consideration that there is a partially dependent relationship between the three levels. Patient outcomes (such as increased daily functioning and reduction of symptoms) may be dependent on organizational changes (such as availability of treatment, waiting times and interprofessional teamwork), which in turn requires change in implementation outcomes (most notably, model fidelity). In addition to the main analysis, five secondary analyses will compare groups based on different combinations of randomization and time periods, specifically before and after each center achieves sufficient PCBH fidelity. DISCUSSION: A randomized comparison of PCBH and traditional primary care has, to our knowledge, not been made before. While the naturalistic setting and the intricacies of implementation pose certain challenges, we have designed this study in an effort to evaluate the causal effects of PCBH despite these complex aspects. The results of this project will be helpful in guiding decisions on how to organize the delivery of behavioral interventions and psychological treatment within the context of primary care in Sweden and elsewhere. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05335382. Retrospectively registered on March 13th, 2022.

Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic.

BACKGROUND: A majority of psychiatric patients suffer from insomnia or insomnia-like problems. In addition to impairing quality of life, sleep problems can worsen psychiatric conditions, such as depression and anxiety, and can make treatment of various psychiatric conditions less successful. Several international guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as first line treatment. However, patients in psychiatric care are rarely offered this treatment, and there is a lack of studies evaluating the treatment in regular psychiatric settings. In this pilot study, we aimed to determine the clinical feasibility of a group-based CBT-I intervention in an outpatient clinical setting for patients with depression, bipolar disorder, anxiety disorders and PTSD. We also aimed to investigate if symptoms of insomnia, depression and anxiety changed after CBT-I. METHODS: Seventeen patients at an out-patient psychiatric clinic for mixed psychiatric problems of anxiety, affective disorders and PTSD, were enrolled in a six-week long group-based CBT-I intervention. Primary outcomes were pre-defined aspects of treatment feasibility. Secondary outcomes were changes in self-reported symptoms of insomnia severity, depression, and anxiety between pre - and post intervention. Assessment of insomnia severity was also performed 3 months after treatment. Feasibility data is reported descriptively, changes in continuous data from pre- to post-treatment were analysed with dependent t-tests. RESULTS: All feasibility criteria were met; there were enough patients to sustain at least one group per semester (e.g., minimum 8), 88% of included patients attended the first session, mean of attended sessions was 4.9 of 6, and drop-out rate was 5.9%. Therapists, recruited from clinical staff, found the treatment manual credible, and possible to use at the clinic. Symptoms of insomnia decreased after treatment, as well as symptoms of depression and anxiety. CONCLUSION: CBT-I could prove as a clinically feasible treatment option for insomnia in a psychiatric outpatient setting. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05379244. Retrospectively registered 18/05/2022.

Very long-term outcome of cognitive behavioral therapy for insomnia: one- and ten-year follow-up of a randomized controlled trial.

Insomnia is a common and chronic disorder, and cognitive behavioral therapy (CBT) is the recommended treatment. Very long-term follow-ups of CBT are very rare, and this study aimed to investigate if improvements were stable one and ten years after CBT for insomnia (CBT-i). Based on a three-armed randomized controlled trial of bibliotherapeutic CBT-i, participants received an insomnia-specific self-help book and were randomized to therapist guidance, no guidance, or a waitlist receiving unguided treatment after a delay. Six weeks of treatment was given to 133 participants diagnosed with insomnia disorder. After one and ten years, participants were assessed with self-reports and interviews. Improvements were statistically significant and well maintained at one- and ten-year follow-ups. Average Insomnia Severity Index score [95%CI] was 18.3 [17.7-18.8] at baseline, 10.1 [9.3-10.9] at post-treatment, 9.2 [8.4-10.0] at one- and 10.7 [9.6-11.8] at ten-year follow-up, and 64% and 66% of participants no longer fulfilled criteria for an insomnia diagnosis at one and ten years, respectively. Positive effects of CBT were still present after ten years. Insomnia severity remained low, and two-thirds of participants no longer fulfilled criteria for an insomnia diagnosis. This extends previous findings of CBT, further confirming it as the treatment of choice for insomnia.

An investigation and replication of sleep-related cognitions, acceptance and behaviours as predictors of short- and long-term outcome in cognitive behavioural therapy for insomnia.

The objectives were to investigate the potential for sleep-related behaviours, acceptance and cognitions to predict outcome (insomnia severity) of cognitive behavioural therapy for insomnia (CBT-I). Baseline and outcome data from four randomised controlled trials (n = 276) were used. Predictors were the Dysfunctional Beliefs and Attitudes about Sleep-10 (DBAS-10), Sleep-Related Behaviours Questionnaire (SRBQ), and Sleep Problems Acceptance Questionnaire (SPAQ), and empirically derived factors from a factor analysis combining all items at baseline (n = 835). Baseline values were used to predict post-treatment outcome, and pre-post changes in the predictors were used to predict follow-up outcomes after 3-6 months, 1 year, or 3-10 years, measured both as insomnia severity and as better or worse long-term sleep patterns. A majority (29 of 52) of predictions of insomnia severity were significant, but when controlling for insomnia severity, only two (DBAS-10 at short-term and SRBQ at mid-term follow-up) of the 12 predictions using established scales, and three of the 40 predictions using empirically derived factors, remained significant. The strongest predictor of a long-term, stable sleep pattern was insomnia severity reduction during treatment. Using all available predictors in an overfitted model, 21.2% of short- and 58.9% of long-term outcomes could be predicted. We conclude that although the explored constructs may have important roles in CBT-I, the present study does not support that the DBAS-10, SRBQ, SPAQ, or factors derived from them, would be unique predictors of outcome.

Suggestions for shaping tinnitus service provision in Western Europe: Lessons from the COVID-19 pandemic.

BACKGROUND: Tinnitus severity has been exacerbated because of the COVID-19 pandemic and those with tinnitus require additional support. Such support should be informed by patient preferences and needs. The objective of this study was to gather information from individuals with tinnitus living in Europe to inform stakeholders of the (a) support they needed in relation to changes associated with the COVID-19 pandemic and (b) suggestions regarding tinnitus care for the future. METHODS: A cross-sectional mixed method study design was used using closed and open-ended questions via an online survey. Data were gathered from 710 adults experiencing tinnitus in Western Europe, with the majority living in The Netherlands, Belgium and Sweden. Data were analysed using qualitative content analysis and descriptive statistics. RESULTS: Those with tinnitus indicated the following support needs during the pandemic (a) support for tinnitus, (b) support for hearing-related difficulties, (c) social support and (d) pandemic-related support. Five directions for future tinnitus care were provided, namely, (a) need for understanding professional support and access to multidisciplinary experts, (b) greater range of therapies and resources, (c) access to more information about tinnitus, (d) prioritising tinnitus research and (e) more support for hearing protection and hearing loss prevention. CONCLUSIONS: The findings point to the need for accessible (remote), patient-centred, suitable and evidence-based tinnitus care. Insights from the current study can be used by various stakeholders including clinical practitioners and tinnitus support services to ensure those with tinnitus have access to the help and support required in order to reduce service provision insufficiencies.

Investigating tinnitus subgroups based on hearing-related difficulties.

PURPOSE: Meaningfully grouping individuals with tinnitus who share a common characteristics (ie, subgrouping, phenotyping) may help tailor interventions to certain tinnitus subgroups and hence reduce outcome variability. The purpose of this study was to test if the presence of tinnitus subgroups are discernible based on hearing-related comorbidities, and to identify predictors of tinnitus severity for each subgroup identified. METHODS: An exploratory cross-sectional study was used. The study was nested within an online survey distributed worldwide to investigate tinnitus experiences during the COVID-19 pandemic. The main outcome measure was the tinnitus Handicap Inventory- Screening Version. RESULTS: From the 3400 respondents, 2980 were eligible adults with tinnitus with an average age of 58 years (SD = 14.7) and 49% (n = 1457) being female. A three-cluster solution identified distinct subgroups, namely, those with tinnitus-only (n = 1306; 44%), those presenting with tinnitus, hyperacusis, hearing loss and/or misophonia (n = 795; 27%), and those with tinnitus and hearing loss (n = 879; 29%). Those with tinnitus and hyperacusis reported the highest tinnitus severity (M = 20.3; SD = 10.5) and those with tinnitus and no hearing loss had the lowest tinnitus severity (M = 15.7; SD = 10.4). Younger age and the presence of mental health problems predicted greater tinnitus severity for all groups (ß ≤ -0.1, P ≤ .016). CONCLUSION: Further exploration of these potential subtypes are needed in both further research and clinical practice by initially triaging tinnitus patients prior to their clinical appointments based on the presence of hearing-related comorbidities. Unique management pathways and interventions could be tailored for each tinnitus subgroup.

Genetics of response to cognitive behavior therapy in adults with major depression: a preliminary report.

Major depressive disorder is heritable and a leading cause of disability. Cognitive behavior therapy is an effective treatment for major depression. By quantifying genetic risk scores based on common genetic variants, the aim of this report was to explore the utility of psychiatric and cognitive trait genetic risk scores, for predicting the response of 894 adults with major depressive disorder to cognitive behavior therapy. The participants were recruited in a psychiatric setting, and the primary outcome score was measured using the Montgomery Åsberg Depression Rating Scale-Self Rated. Single-nucleotide polymorphism genotyping arrays were used to calculate the genomic risk scores based on large genetic studies of six phenotypes: major depressive disorder, bipolar disorder, attention-deficit/hyperactivity disorder, autism spectrum disorder, intelligence, and educational attainment. Linear mixed-effect models were used to test the relationships between the six genetic risk scores and cognitive behavior therapy outcome. Our analyses yielded one significant interaction effect (B = 0.09, p < 0.001): the autism spectrum disorder genetic risk score correlated with Montgomery Åsberg Depression Rating Scale-Self Rated changes during treatment, and the higher the autism spectrum disorder genetic load, the less the depressive symptoms decreased over time. The genetic risk scores for the other psychiatric and cognitive traits were not related to depressive symptom severity or change over time. Our preliminary results indicated, as expected, that the genomics of the response of patients with major depression to cognitive behavior therapy were complex and that future efforts should aim to maximize sample size and limit subject heterogeneity in order to gain a better understanding of the use of genetic risk factors to predict treatment outcome.

Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study.

BACKGROUND: Hypersexual disorder (HD) is a condition in which the individual experiences loss of control over engagement in sexual behaviors, leading to negative effects on various areas of life. Paraphilias often present concomitantly with HD, and although cognitive behavioral therapy (CBT) has been proven to reduce engagement in hypersexual behavior, no studies have investigated the effects of Internet-administered CBT (ICBT) on HD, with or without paraphilia(s) or paraphilic disorder(s). AIM: To investigate the effects of Internet-administered CBT on HD, with or without paraphilia(s) or paraphilic disorder(s). METHODS: Male participants (n = 36) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12 weeks of ICBT. Measures were administered weekly over the treatment period, with an additional follow-up measurement 3 months after completion of treatment. An assessment interview was performed 2 weeks after treatment. OUTCOMES: The primary outcome was the Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder: Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8). RESULTS: Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms. These effects remained stable 3 months after treatment. CLINICAL IMPLICATIONS: ICBT can ameliorate HD symptoms, psychiatric distress, and paraphilic symptoms, which suggests that the ICBT for HD, with or without paraphilia(s) or paraphilic disorder(s), may constitute a valuable addition of treatment options in clinical settings. STRENGTHS AND LIMITATIONS: This is the first study evaluating the efficacy of ICBT on a sample of men suffering from HD. In addition, a proportion of the sample reported concomitant paraphilic interests and disorders, thus mirroring an everyday clinical practice in the field of sexual medicine. No control group was assigned, and some of the outcome measures are still to be validated. The long-term effects of ICBT and its efficacy in hypersexual women are unknown. CONCLUSIONS: This study gives support for ICBT as an effective treatment option for HD. Future evaluations of the treatment program should include women and larger samples in randomized controlled procedures and investigate the long-term effects. Hallberg J, Kaldo V, Arver S, et al. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med 2020;17:2039-2054.

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.

Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: A randomized controlled trial.

OBJECTIVE: Internet-delivered interventions may alleviate distress in cancer survivors with limited access to psychological face-to-face treatment. In collaboration with a group of cancer survivors, we developed and tested the efficacy of a therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program for anxiety and depression in cancer survivors. METHODS: A total of 1282 cancer survivors were screened for anxiety and depression during their routine oncology follow-up; eligible breast (n = 137) and prostate cancer (n = 13) survivors were randomized to iMBCT or care-as-usual (CAU) wait-list. Primary outcomes of anxiety and depression were assessed at baseline, 5 weeks, 10 weeks (post intervention), and 6 months. RESULTS: Significant effects were found for both anxiety (Cohen's d = 0.45; P = .017) and depressive symptoms (d = 0.42; P = .024) post intervention. The effects were maintained at follow-up for anxiety (d = 0.40; P = .029), but not for depressive symptoms (d = 0.28; P = .131). CONCLUSIONS: Our preliminary findings suggest iMBCT to be a helpful intervention for cancer survivors suffering from symptoms of anxiety. Further studies on the efficacy for symptoms of depression are needed.

A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men.

BACKGROUND: Hypersexual disorder (HD) is defined as a condition in which the individual loses control over engagement in sexual behaviors, leading to distress and negative effects on key life areas. Cognitive behavioral therapy (CBT) has been proven to reduce symptoms of hypersexual behavior; however, no randomized controlled study of CBT interventions for HD has been reported previously. AIM: To investigate the efficacy of group-administered CBT for HD. METHODS: Male participants (n = 137) diagnosed with HD, were randomized between 7 weeks of group-administered CBT (n = 70) and a waitlist control receiving the intervention after 8 weeks (n = 67). Measurements were administered at pre-, mid-, and posttreatment, with follow-up after 3 and 6 months. OUTCOMES: The primary outcome was the Hypersexual Disorder: Current Assessment Scale (HD:CAS), and secondary outcomes were the Sexual Compulsivity Scale (SCS) and measures of depression (Montgomery-Åsberg Depression Rating Scale (MADRS-S), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), and treatment satisfaction (CSQ-8). RESULTS: A significantly greater decrease in HD symptoms and sexual compulsivity, as well as significantly greater improvements in psychiatric well-being, were found for the treatment condition compared with the waitlist. These effects remained stable at 3 and 6 months after treatment. CLINICAL IMPLICATIONS: CBT can ameliorate HD symptoms and psychiatric distress, suggesting that the CBT program may serve as a first-line treatment in clinical settings. STRENGTHS & LIMITATIONS: This is the first randomized controlled study evaluating the efficacy of a CBT program in a rather large sample of HD-specific diagnosed men. The long-term treatment effects are vague due to the low response rate on follow-up measurements, and the efficacy of this program for hypersexual women remains unknown. CONCLUSION: This study supports the efficacy of a group-administered CBT program as a treatment option for HD; however, future studies should include women, comprise dismantling analysis of the constituting interventions, and evaluate other treatment formats, for example, administration via the Internet. Hallberg J, Kaldo V, Arver S, et al. A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men. J Sex Med 2019;16:733-745.

Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation.

BACKGROUND: Sleep disturbances, including insomnia, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD. The purpose of this study was to investigate if patients with insomnia and other sleep problems, at a specialist clinic for ADHD, benefit from a group delivered behavioral treatment based on CBT-i; whether insomnia severity improves following this treatment. METHODS: This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD. As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting several sleep problems prevalent in the ADHD-population, was offered as 10 weekly 90-min group sessions and scheduled telephone support. All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat. RESULTS: Nineteen patients (37 [SD 13.7] years; 68% female) with ADHD and subjectively reported sleep problems provided informed consent and pre-treatment measures. Patients had suffered from sleep problems for 15.3 [SD 13.4] years, 42% used sleep medications, 79% used stimulant medication(s). At post-treatment, insomnia severity (Insomnia Severity Index; score range 0-28) had improved with 4.5 points (95% CI, 2.06-6.99, p = .002), at 3 months with 6.8 points (95% CI, 4.71-8.91, p < .0001) from pre-treatment. CONCLUSIONS: CBT-i adjusted for ADHD is promising for improving insomnia severity in adult patients at specialist psychiatric out-patient clinics, who suffer from ADHD and sleep disturbances. TRIAL REGISTRATION: Study registered with the Regional ethical review board in Stockholm, January 13th 2016, Study id: 2015/2078-31/1. Study registered retrospectively with Clinicaltrials.org, February 21st 2019, ID: NCT03852966.

The effects of component-specific treatment compliance in individually tailored internet-based treatment.

The objective of this study was to explore the effects of treatment compliance in a guided individually tailored internet-based treatment (TAIL) in relation to depression and co-morbid symptoms. Compliance with the homework in the different treatment components in TAIL, each aimed at a specific condition, was rated for 207 participants by independent assessors. Six subgroups (n = 34-131) were constructed consisting of participants with co-occurring symptoms of worry, panic, social anxiety, stress, insomnia, or pain. For each group, hierarchical regression was used to investigate whether the total sum of compliance points, Overall Compliance, predicted reductions in depression and in condition-specific symptoms. Also, in each subgroup, it was tested whether working with specific treatment components, Specific Compliance, predicted reduction of the targeted symptoms. Overall Compliance predicted 15% of the reduction in depression symptoms. For participants with worry, panic, social anxiety, stress, or insomnia, Overall Compliance also predicted symptom reductions in that specific condition. Specific Compliance predicted reduction in the targeted symptoms for participants with social anxiety, stress, and insomnia. Specific Compliance with stress and insomnia components also predicted reductions in depression. Our results strengthen the importance of compliance in internet-based treatments. Because compliance with stress and insomnia components was particularly important for broad symptom reductions, these conditions should not be ignored when treating patients with co-morbid symptoms.