"The worst thing is lying in bed thinking 'I want a cigarette'" a qualitative exploration of smoker's and ex-smoker's perceptions of sleep during a quit attempt and the use of cognitive behavioural therapy for insomnia to aid cessation.

Smokers report poorer sleep quality than non-smokers and sleep quality deteriorates further during cessation, increasing risk of smoking relapse. Despite the use of cognitive behavioural therapy for insomnia (CBT-I) to aid quit attempts emerging in the area, little is known about smokers and ex smoker's experiences of sleep during a quit attempt or their perceptions of CBT-I. This study addresses this gap by exploring smoker's and ex-smoker's experiences of the link between smoking and sleep and how this may change as a function of smoking/smoking abstinence. It also explores views of traditional CBT-I components (i.e., perceived feasibility, effectiveness, barriers of use). We conducted semi-structured interviews with current and recently quit smokers (n = 17) between January and September 2022. The framework method was used for analysis. Four themes addressing research questions were described. These included: 1) A viscous cycle; poor sleep quality and negative psychological state during cessation; 2) Perceived engagement and effectiveness; the importance of feasibility, experience, value, identity and psychological state in assessing CBT-I as a cessation tool; 3) Striking a balance; tailoring CBT-I to reduce psychological overload in a time of lifestyle transition; and 4) Personalisation and digital delivery helping overcome psychological barriers during cessation. The analysis suggested during quit attempts smokers experienced a range of sleep problems that could increase risk of relapse due to a negative impact on psychological state. It also revealed participants thought that CBT-I is something they would use during a quit attempt but suggested changes and additions that would improve engagement and be better tailored to quitting smokers. Key additions included the integration of smoking-based cognitive restructuring, starting the intervention prior to a quit attempt, and the need for personalisation and tailoring.

Feasibility and acceptability of an integrated mind-body intervention for depression: whole-body hyperthermia (WBH) and cognitive behavioral therapy (CBT).

OBJECTIVE: To examine the feasibility of an integrated mind-body MDD treatment combining cognitive behavioral therapy (CBT) and whole-body hyperthermia (WBH). METHODS: In this single-arm trial, 16 adults with MDD initially received 8 weekly CBT sessions and 8 weekly WBH sessions. Outcomes included WBH sessions completed (primary), self-report depression assessments completed (secondary), and pre-post intervention changes in depression symptoms (secondary). We also explored changes in mood and cognitive processes and assessed changes in mood as predictors of overall treatment response. RESULTS: Thirteen participants (81.3%) completed ≥ 4 WBH sessions (primary outcome); midway through the trial, we reduced from 8 weekly to 4 bi-weekly WBH sessions to increase feasibility. The n = 12 participants who attended the final assessment visit completed 100% of administered self-report depression assessments; all enrolled participants (n = 16) completed 89% of these assessments. Among the n = 12 who attended the final assessment visit, the average pre-post-intervention BDI-II reduction was 15.8 points (95% CI: -22.0, -9.70), p = 0.0001, with 11 no longer meeting MDD criteria (secondary outcomes). Pre-post intervention improvements in negative automatic thinking, but not cognitive flexibility, achieved statistical significance. Improved mood from pre-post the initial WBH session predicted pre-post treatment BDI-II change (36.2%; rho = 0.60, p = 0.038); mood changes pre-post the first CBT session did not. LIMITATIONS: Small sample size and single-arm design limit generalizability. CONCLUSION: An integrated mind-body intervention comprising weekly CBT sessions and bi-weekly WBH sessions was feasible. Results warrant future larger controlled clinical trials.Clinivaltrials.gov Registration: NCT05708976.

Telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy: a feasibility study.

PURPOSE: Sleep quality commonly deteriorates in people receiving chemotherapy for breast cancer (BC). We aimed to determine feasibility and acceptability of telehealth-delivered cognitive behaviour therapy for insomnia (CBT-I) in people with early BC receiving (neo)adjuvant chemotherapy. METHODS: Multi-centre, single arm, phase 2 feasibility trial. People with stage I-III BC received 4 sessions of telehealth CBT-I over 8 weeks, during chemotherapy. Participants completed Pittsburgh Sleep Quality Index (PSQI) and other Patient Reported Outcome Measures (PROMs) at baseline, post-program (week 9) and post-chemotherapy (week 24); and an Acceptability Questionnaire at week 9. Primary endpoint was proportion completing 4 sessions of telehealth CBT-I. RESULTS: In total, 41 participants were recruited: mean age 51 years (range 31-73). All 4 CBT-I sessions were completed by 35 (85%) participants. Acceptability of the program was high and 71% reported 'the program was useful'. There was no significant difference in the number of poor sleepers (PSQI score ≥ 5) at baseline 29/40 (73%) and week 24 17/25 (68%); or in the mean PSQI score at baseline (7.43, SD 4.06) and week 24 (7.48, SD 4.41). From baseline to week 24, 7/25 (28%) participants had a ≥ 3 point improvement in sleep quality on PSQI, and 5/25 (20%) had a ≥ 3 point deterioration. There was no significant difference in mean PROM scores. CONCLUSION: It is feasible to deliver telehealth CBT-I to people with early BC receiving chemotherapy. Contrary to literature predictions, sleep quality did not deteriorate. Telehealth CBT-I has a potential role in preventing and managing sleep disturbance during chemotherapy. Australian New Zealand Clinical Trials Registry (ANZCTR) registration number: ACTRN12620001379909 and date 22/12/2020.

Application of an egocentric social network approach to examine changes in social connections following treatment for anxiety and depression: A novel measurement tool for clinical trials research?

The epidemic of loneliness and social isolation has been recognized as a public health crisis warranting the same prioritization as other public health issues today, such as obesity, substance use disorders, and tobacco use. Social disconnection is particularly prevalent and disabling among individuals with anxiety and depression, yet it is inadequately evaluated and addressed in most clinical psychology treatment research. Studies generally employ global measures of perceived connectedness, loneliness, or relationship satisfaction, limiting understanding about elements of one's social network that may change with treatment. This study examined changes in the degree (number of people nominated) and quality of one's social network from pre-to post-treatment using an egocentric social network approach in 59 adults (mean age = 30.8 years, range = 18 to 54) with clinically elevated anxiety or depression who were randomized to a cognitive and behavioral positive valence treatment versus waitlist. Participants (egos) named people in their lives (alters) with whom they discussed important issues or spent free time. For each alter, participants rated how close they felt, how close they thought the alter felt to them, and how frequently they communicated. Linear regressions, which included treatment group as a predictor, revealed no group differences in changes in network degree, perceived alter feelings of closeness, or communication frequency, despite prior findings from this sample indicating larger increases in perceived global connectedness in the treatment group. Unexpectedly, the control group reported a greater increase in perceived closeness to alters. Post-hoc analyses revealed this was explained by the treatment group identifying more distal social ties (e.g., extended family, colleagues, roommates) as alters following treatment - an outcome positively associated with global improvements in connectedness. This proof-of-concept study suggests egocentric social network surveys may provide unique information on treatment-related changes in social functioning. Suggestions are provided for adaptations to facilitate application of social network surveys to mental health treatment research.

Cognitive Training for Reduction of Delirium in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial.

IMPORTANCE: Postoperative delirium is a common and impactful neuropsychiatric complication in patients undergoing coronary artery bypass grafting surgery. Cognitive training may enhance cognitive reserve, thereby reducing postoperative delirium. OBJECTIVE: To determine whether preoperative cognitive training reduces the incidence of delirium in patients undergoing coronary artery bypass grafting. DESIGN, SETTING, and PARTICIPANTS: This prospective, single-blind, randomized clinical trial was conducted at 3 university teaching hospitals in southeastern China with enrollment between April 2022 and May 2023. Eligible participants included those scheduled for elective coronary artery bypass grafting who consented and enrolled at least 10 days before surgery. INTERVENTIONS: Participating patients were randomly assigned 1:1, stratified by site, to either routine care or cognitive training, which included substantial practice with online tasks designed to enhance cognitive functions including memory, imagination, reasoning, reaction time, attention, and processing speed. MAIN OUTCOMES AND MEASURES: The primary outcome was occurrence of delirium during postoperative days 1 to 7 or until hospital discharge, diagnosed using the Confusion Assessment Method or the Confusion Assessment Method for Intensive Care Units. Secondary outcomes were postoperative cognitive dysfunction, delirium characteristics, and all-cause mortality within 30 days following the operation. RESULTS: A total of 218 patients were randomized and 208 (median [IQR] age, 66 [58-70] years; 64 female [30.8%] and 144 male [69.2%]) were included in final analysis, with 102 randomized to cognitive training and 106 randomized to routine care. Of all participants, 95 (45.7%) had only a primary school education and 54 (26.0%) had finished high school. In the cognitive training group, 28 participants (27.5%) developed delirium compared with 46 participants (43.4%) randomized to routine care. Those receiving cognitive training were 57% less likely to develop delirium compared with those receiving routine care (adjusted odds ratio [aOR] 0.43; 95% CI, 0.23-0.77; P = .007). Significant differences were observed in the incidence of severe delirium (aOR, 0.46; 95% CI, 0.25-0.82; P = .01), median (IQR) duration of delirium (0 [0-1] days for cognitive training vs 0 [0-2] days for routine care; P = .008), and median (IQR) number of delirium-positive days (0 [0-1] days for cognitive training vs 0 [0-2] days for routine care; P = .007). No other secondary outcomes differed significantly. CONCLUSIONS AND RELEVANCE: In this randomized trial of 208 patients undergoing coronary artery bypass grafting, preoperative cognitive training reduced the incidence of postoperative delirium. However, our primary analysis was based on fewer than 75 events and should therefore be considered exploratory and a basis for future larger trials. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2200058243.

Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment following chemotherapy for aggressive lymphoma: protocol for a randomised pilot trial.

INTRODUCTION: Cancer-related cognitive impairment is common among people diagnosed with and treated for cancer. This can be a distressing and disabling side effect for impacted individuals. Interventions to mitigate cognitive dysfunction are available, but, to date, most have been trialled in samples that are largely or exclusively composed of people with solid tumours. Intervention strategies to support cognitive functioning are needed, but there is a paucity of research in this area. The main aim of this study is to test the feasibility and acceptability of methods and procedures intended for use in a definitive trial of a web-based cognitive rehabilitation programme, Responding to Cognitive Concerns (eReCog), in people who have received chemotherapy for aggressive lymphoma. METHODS AND ANALYSIS: The proposed study is a single-site, parallel-group, pilot randomised controlled trial, with one baseline and one follow-up (or postintervention) assessment. 38 people from the target population with low perceived cognitive function based on the Cognitive Change Screen will be recruited from a specialist cancer centre between July 2023 and June 2024. After baseline assessment, participants will be randomised one-to-one to receive usual care only (a factsheet about changes in memory and thinking for people with cancer) or eReCog plus usual care. The 4-week eReCog intervention consists of four online modules offering psychoeducation on cognitive impairment associated with cancer and its treatment, skills training for improving memory, and attention and relaxation training. Study outcomes will include the feasibility of recruitment and retention at follow-up assessment (primary outcomes), as well as adherence to, usability of and intrinsic motivation to engage with eReCog, and compliance with study measures. The potential efficacy of eReCog will also be evaluated. ETHICS AND DISSEMINATION: Ethical approval was granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee in Victoria, Australia (HREC/97384/PMCC). Study findings will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry, ACTRN12623000705684.

Behavioral Therapy for People With Diabetes Who Smoke: A Scoping Review.

BACKGROUND: Tobacco smoking exacerbates diabetes-related complications; its prevalence is notwithstanding substantial. Persons with diabetes face a number of barriers and challenges to quitting such as multiple lifestyle restrictions; tailored interventions are required for smoking cessation. OBJECTIVE: To identify research on behavioral interventions for smoking cessation in diabetes. METHODS: Studies had to be randomized controlled trials, quasiexperimental or systematic reviews. The behavioral interventions included were: the 5As, Cognitive-Behavioral Therapy, Motivational Interviewing, Contingency Management, Health Coaching and Counselling, as compared to standard care. The outcomes were self-reported and/or biochemically verified smoking cessation. CINAHL Complete, MEDLINE Complete, the Cochrane databases of systematic reviews and randomized controlled trials, PsychInfo and PubMed Central were searched until July, 2023. Keywords used included diabetes, smoking cessation and each of the behavioral interventions included. RESULTS: 1615 papers were identified. Three studies on the 5As/brief advice, 4 on Motivational Intervention and 1 on counseling were retained. The results on the 5As and Motivational Interviewing were conflicting. More intensive interventions appear to be more successful in achieving smoking cessation in smokers with diabetes. CONCLUSIONS: Future research should focus on the continued development and evaluation of structured smoking cessation interventions based on the 5As, Motivational interviewing and Cognitive Behavioral Therapy.

Assessing the Clinical Efficacy of a Virtual Reality Tool for the Treatment of Obesity: Randomized Controlled Trial.

BACKGROUND: Virtual reality (VR) interventions, based on cognitive behavioral therapy principles, have been proven effective as complementary tools in managing obesity and have been associated with promoting healthy behaviors and addressing body image concerns. However, they have not fully addressed certain underlying causes of obesity, such as a lack of motivation to change, low self-efficacy, and the impact of weight stigma interiorization, which often impede treatment adherence and long-term lifestyle habit changes. To tackle these concerns, this study introduces the VR self-counseling paradigm, which incorporates embodiment and body-swapping techniques, along with motivational strategies, to help people living with obesity effectively address some of the root causes of their condition. OBJECTIVE: This study aims to assess the clinical efficacy of ConVRself (Virtual Reality self-talk), a VR platform that allows participants to engage in motivational self-conversations. METHODS: A randomized controlled trial was conducted with 68 participants from the bariatric surgery waiting list from the obesity unit of the Vall d'Hebron University Hospital in Barcelona, Spain. Participants were assigned to 1 of 3 groups: a control group (CG), which only received treatment as usual from the obesity unit; experimental group 1 (EG1), which, after intensive motivational interviewing training, engaged in 4 sessions of VR-based self-conversations with ConVRself, and underwent embodiment and body-swapping techniques; and experimental group 2 (EG2), which engaged in 4 VR-based sessions led by a virtual counselor with a prerecorded discourse, and only underwent the embodiment technique. In the case of both EG1 and EG2, the VR interventions were assisted by a clinical researcher. Readiness to change habits, eating habits, and psychological variables, as well as adherence and satisfaction with ConVRself were measured at baseline, after the intervention, 1 week after the intervention, and 4 weeks after the intervention. RESULTS: Regarding the primary outcomes, EG1 (24/68, 35%) and EG2 (22/68, 32%) showed significant improvements in confidence to lose weight compared to the CG (22/68, 32%) at all assessment points (ß=-.16; P=.02). Similarly, EG1 demonstrated a significant increase after the intervention in readiness to exercise more compared to the CG (ß=-.17; P=.03). Regarding the secondary outcomes, EG1 participants showed a significant reduction in uncontrolled eating (ß=.71; P=.01) and emotional eating (ß=.29; P=.03) compared to the CG participants, as well as in their anxiety levels compared to EG2 and CG participants (ß=.65; P=.01). In addition, participants from the experimental groups reported high adherence and satisfaction with the VR platform (EG1: mean 59.82, SD 4.00; EG2: mean 58.43, SD 5.22; d=0.30, 95% CI -0.30 to 0.89). CONCLUSIONS: This study revealed that using VR self-conversations, based on motivational interviewing principles, may have benefits in helping people with obesity to enhance their readiness to change habits and self-efficacy, as well as reduce dysfunctional eating behaviors and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05094557; https://www.clinicaltrials.gov/study/NCT05094557.

Contingency management for smoking cessation for individuals with overweight or obesity: A randomized controlled trial.

BACKGROUND: Interventions for quitting smoking and weight control among individuals with excess weight are scarce. Our study evaluated the effectiveness of cognitive behavioral therapy (CBT) plus contingency management (CM) in this population, and examined whether CM for smoking cessation improved CBT treatment outcomes at end of treatment (EOT) and at 1-, 3-, 6-, and 12-month follow-ups (FU). METHODS: In an 8-week randomized clinical trial, 120 adults who smoke with overweight or obesity (54.16% females; MBMI = 31.75 ± 4.31) were randomly assigned to CBT for both quitting smoking and weight control (n = 60) or the same treatment plus CM for smoking cessation (n = 60). Outcome variables were compared (i.e., treatment completion, smoking abstinence, weight change and secondary outcomes). RESULTS: At EOT, the CBT + CM group achieved 78.33% 7-day point-prevalence abstinence rates compared to 61.67% in the CBT group (p = .073), and rates declined over time (12-month FU: 18% vs 12%). Participants who attained abstinence weighed more compared to baseline at EOT (Mkg = 1.07; SD = 1.88) and over time (12-month FU: Mkg = 4.19; SD = 4.31). No differences were found between the two groups in outcome variables. CONCLUSIONS: Both interventions were effective in promoting abstinence and reducing tobacco use over time. Combining CBT with CM for smoking cessation did not improve treatment outcomes in individuals with overweight or obesity compared to CBT only. Future studies should evaluate whether implementing CM for weight maintenance helps control post-cessation weight gain in this population.

Cognitive Functional Therapy compared with usual physiotherapy care in people with persistent low back pain: a mixed methods feasibility randomised controlled trial in the United Kingdom National Health Service.

OBJECTIVES: To determine the feasibility of completing a definitive randomised controlled trial (RCT), evaluating the clinical and cost-effectiveness of Cognitive Functional Therapy (CFT) in comparison to usual physiotherapy care (UPC), for people with persistent low back pain (LBP). DESIGN AND SETTING: A two-arm parallel feasibility RCT completed in a United Kingdom (UK) Secondary Care National Health Service (NHS) physiotherapy service. PARTICIPANTS: Sixty adult participants who reported LBP lasting for more than three months, that was not attributable to a serious (e.g. cancer) or specific (e.g. radiculopathy) underlying cause, were invited to participate. Participants were allocated at random to receive CFT or UPC. INTERVENTIONS: Cognitive Functional Therapy and Usual Physiotherapy Care for persistent LBP. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of completing a definitive RCT, defined by recruitment of at least 5 participants per month, delivery of CFT per protocol and securing relevant and acceptable outcome measures. Data concerning study processes, resources, management and participant reported outcome measures were collected at baseline, 3, 6 and 12-month follow-up. RESULTS: Sixty participants (n = 30 CFT and n = 30 UPC) were recruited with 80% (n = 48), 72% (n = 43) and 53% (n = 32) retained at 3, 6 and 12-month follow-up respectively. NHS physiotherapists were trained to competence and delivered CFT with fidelity. CFT was tolerated by participants with no adverse events. Relevant and clinically important outcome data were collected at all time points (0.4%, 3%, 1% and 0.8% of data was missing from the returned outcome measure booklets at baseline and 3, 6 and 12-month follow-up respectively). The Roland-Morris disability questionnaire was considered the most suitable primary outcome measure with a proposed sample size of 540 participants for a definitive cluster RCT. CONCLUSION: It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future study should incorporate an internal pilot to address aspects of feasibility further, including participant retention strategies. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN12965286 CONTRIBUTION OF THE PAPER.

An investigation of the effect of mindfulness-integrated cognitive behavior therapy on demoralization, body image, and sexual function in Iranian women with breast cancer: a randomized controlled trial.

BACKGROUND: Breast cancer is an extremely unpleasant and unbearable experience that can have a profound impact on a person's life. Compared to other types of cancer, breast cancer has a more severe psychological impact on women. PURPOSE: This study aimed to investigate the effect of mindfulness-integrated cognitive behavior therapy on demoralization, body image, and sexual function in Iranian women with breast cancer. METHOD: A sample of 30 women with breast cancer were randomly divided into intervention and control groups. The research was conducted in the oncology division of Imam Reza Hospital in Kermanshah by the clinical trial method with a two-group pretest-posttest design and a 2 month follow-up. Participants in the intervention group received Mindfulness-integrated cognitive behavior therapy for eight sessions. The intervention was carried out individually in weekly 60 min sessions. While the control group received self-help treatment (through an educational book). A demographic questionnaire, Demoralization Scale (DS-II), Body Image Scale (BIS), and Female Sexual Function Index (FSFI) were used to collect data. For data analysis, means and standard deviations were calculated and repeated measures and the Bonferroni test was conducted using SPSS 26. RESULTS: The results showed the effectiveness of mindfulness-integrated cognitive behavior therapy on demoralization, body image, and sexual function (p < 0.05). Concerning demoralization in the intervention group, the pre-test mean was 16.73 ± 3.33, and it reduced to 11.93 ± 1.49 in the post-test. The body image mean score showed a decreasing trend in the intervention group, from 12.47 ± 1.88 in the pre-test to 8.80 ± 3.21 in the post-test. The mean score for sexual function showed an increasing trend, increasing from 18.06 ± 2.29 in the pre-test to 23.07 ± 0.91 in the post-test. There was no significant difference in the mean score of the post-test compared to the pre-test and follow-up in the control group (p < 0.05). CONCLUSION: MICBT can be used in conjunction with pharmaceuticals and medical treatments to improve the psychological symptoms of women with breast cancer, according to this study's results. Trial registration (IRCT20160103025817N6). 2022-04-06.

EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial.

INTRODUCTION: Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP. METHODS: The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior. CONCLUSION: This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.

Cognitive behavioural therapy without medication for schizophrenia.

BACKGROUND: Cognitive behavioural therapy (CBT) can be effective in people with schizophrenia when provided in combination with antipsychotic medication. It remains unclear whether CBT could be safely and effectively offered in the absence of concomitant antipsychotic therapy. OBJECTIVES: To investigate the effects of CBT for schizophrenia when administered without concomitant pharmacological treatment with antipsychotics. SEARCH METHODS: We conducted a systematic search on 6 March 2022 in the Cochrane Schizophrenia Group's Study-Based Register of Trials, which is based on CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PubMed, ClinicalTrials.gov, and WHO ICTRP. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people with schizophrenia comparing CBT without antipsychotics to standard care, standard care without antipsychotics, or the combination of CBT and antipsychotics. DATA COLLECTION AND ANALYSIS: Two review authors independently screened references for inclusion, extracted data from eligible studies, and assessed risk of bias using Cochrane's RoB 2 tool. We contacted study authors for missing data and additional information. Our primary outcome was general mental state measured with a validated rating scale. Key secondary outcomes were specific symptoms of schizophrenia, relapse, service use, number of participants leaving the study early, functioning, quality of life, and number of participants actually receiving antipsychotics during the trial. We also assessed behaviour, adverse effects, and mortality. MAIN RESULTS: We included 4 studies providing data for 300 participants (average age 21.94 years). The mean sample size was 75 participants (range 61 to 90 participants). Study duration was between 26 and 39 weeks for the intervention period and 26 to 104 weeks for the follow-up period. Three studies employed a blind rater, while one study was triple-blind. All analyses included data from a maximum of three studies. The certainty of the evidence was low or very low for all outcomes. For the primary outcome overall symptoms of schizophrenia, results showed a difference favouring CBT without antipsychotics when compared to no specific treatment at long term (> 1 year mean difference measured with the Positive and Negative Syndrome Scale (PANSS MD) -14.77, 95% confidence interval (CI) -27.75 to -1.79, 1 RCT, n = 34). There was no difference between CBT without antipsychotics compared with antipsychotics (up to 12 months PANSS MD 3.38, 95% CI -2.38 to 9.14, 2 RCTs, n = 63) (very low-certainty evidence) or compared with CBT in combination with antipsychotics (up to 12 months standardised mean difference (SMD) 0.30, 95% CI -0.06 to 0.65, 3 RCTs, n = 125). Compared with no specific treatment, CBT without antipsychotics was associated with a reduction in overall symptoms (as described above) and negative symptoms (PANSS negative MD -4.06, 95% CI -7.50 to -0.62, 1 RCT, n = 34) at longer than 12 months. It was also associated with a lower duration of hospital stay (number of days in hospital MD -22.45, 95% CI -28.82 to -16.08, 1 RCT, n = 74) and better functioning (Personal and Social Performance Scale MD -12.42, 95% CI -22.75 to -2.09, 1 RCT, n = 40, low-certainty evidence) at up to 12 months. We did not find a difference between CBT and antipsychotics in any of the investigated outcomes, with the exception of adverse events measured with the Antipsychotic Non-Neurological Side-Effects Rating Scale (ANNSERS) at both 6 and 12 months (MD -4.94, 95% CI -8.60 to -1.28, 2 RCTs, n = 48; MD -6.96, 95% CI -11.55 to -2.37, 2 RCTs, n = 42). CBT without antipsychotics was less effective than CBT combined with antipsychotics in reducing positive symptoms at up to 12 months (SMD 0.40, 95% CI 0.05 to 0.76, 3 RCTs, n = 126). CBT without antipsychotics was associated with a lower number of participants experiencing at least one adverse event in comparison with CBT combined with antipsychotics at up to 12 months (risk ratio 0.36, 95% CI 0.17 to 0.80, 1 RCT, n = 39, low-certainty evidence). AUTHORS' CONCLUSIONS: This review is the first attempt to systematically synthesise the evidence about CBT delivered without medication to people with schizophrenia. The limited number of studies and low to very low certainty of the evidence prevented any strong conclusions. An important limitation in the available studies was that participants in the CBT without medication group (about 35% on average) received antipsychotic treatment, highlighting the challenges of this approach. Further high-quality RCTs are needed to provide additional data on the feasibility and efficacy of CBT without antipsychotics.

Effect of cognitive-behavior therapy for children with functional abdominal pain: a meta-analysis.

BACKGROUND: Cognitive-Behavior Therapy (CBT) is the validated non-pharmacological treatment for chronic pain in pediatric patients. While some suggested CBT were comparable to the usual care in reducing children's functional abdominal pain. This meta-analysis was designed to systematically review the literature for RCTs that investigated the efficacy of CBT in children with functional abdominal pain (FAP). METHODS: PubMed, Embase, and the Cochrane library were searched for papers published up to October 2022. Studies applying different CBT delivery methods (in-person, web-based, phone-based) were included in this meta-analysis to evaluate the comprehensive effectiveness of CBT compared with usual care. Weighted and standardized mean difference with the 95% confidence intervals were used for the synthesis of the results. Primary outcome was the decrease of functional disability inventory (FDI) and the secondary outcomes were the decrease of severity in pain intensity, depression, anxiety, gastrointestinal symptoms, and improvement in physical quality of life (QoL). RESULTS: A total of 10 RCTs with 1187 children were included in the final analysis. The results showed that CBT resulted in better effect in reducing functional disability inventory (SMD=-2.282, 95%CI: -4.537 to -0.027, P = 0.047), pain intensity (SMD=-0.594, 95%CI: -1.147 to -0.040, P = 0.036), and improving QoL (SMD = 14.097, 95%CI: 0.901 to 27.292, P = 0.036) compared with the control groups. Comparable effects were observed in the severity of depression (SMD=-0.493, 95%CI: -1.594 to 0.608, P = 0.380), anxiety (SMD=-0.062, 95%CI: -0.640 to 0.517, P = 0.835), and gastrointestinal symptoms (SMD=-1.096 95%CI: -2.243 to 0.050, P = 0.061) between CBT and usual treatment. CONCLUSIONS: We observed the differences in post-treatment FAP and pain intensity for children receiving CBT compared with children receiving treatment as usual. CBT in the setting of FAP demonstrates promising developments and highlights the need for future research.

Effects of cognitive behavioral therapy on anxiety and depressive symptoms in advanced cancer patients: A meta-analysis.

OBJECTIVE: To evaluate the effects of cognitive behavioral therapy on anxiety and depressive symptoms in patients with advanced cancer. METHODS: A systematical search was conducted on Embase, PubMed, Web of Science, Cochrane Library, PsycINFO, Chinese Biomedical Database, CNKI, VIP Database, and Wanfang database, and the search time was from the inception to May 26, 2023. Randomized controlled trials focusing on the effects of cognitive behavioral therapy on anxiety and depressive symptoms in patients with advanced cancer were collected using relevant terms such as advanced stage, cancer, anxiety, depression, and cognitive behavioral therapy. The quality of included studies was evaluated using the Cochrane risk of bias (ROB 2.0) tool, and meta-analysis was performed using RevMan5.4 software. RESULTS: 15 articles, including 1,597 patients, were included. Twelve of the studies reported the effect of CBT on anxiety symptoms in 1,485 advanced cancer patients; Fifteen studies reported the effect of CBT on depressive symptoms in 1,861 advanced cancer patients. The results of meta-analysis showed that CBT was effective in decreasing anxiety [SMD = -0.55, 95% CI (-0.82, -0.27), P < 0.001, I2 = 84%] and depressive symptoms [SMD = -0.38, 95% CI (-0.58, -0.17), P < 0.001, I2 = 78%] in patients with advanced cancer compared to controls, especially the interventions that were delivered lasted for 2-8 weeks. CONCLUSION: Cognitive behavioral therapy lasting for 2-8 weeks is effective for anxiety and depressive symptoms in advanced cancer patients to a moderate degree, but more rigorous research is needed to guide the choice between online and face-to-face delivery mode and the priority of self-guided versus therapist-guided interventions still needs to be studied.

Self-Control in Pediatric Migraine Management: A Topical Review.

OBJECTIVE : This review examines the role that two types of self-control may play in youth's self-management of migraine. Although traditionally conceptualized from an inhibitory lens, self-control has both initiatory and inhibitory functions, and the authors suggest the distinction is important in relation to youth's ability to adhere to different components of migraine treatment regimens. METHODS : A topical review of the literature was conducted to identify evidence-based interventions to treat pediatric migraine and conceptualize the role self-control (both initiatory and inhibitory) may play in adherence to its regimen. Both PsycInfo and PubMed databases were used to identify relevant articles. RESULTS : Existing evidence-based interventions and recommendations for pediatric migraine require inhibitory self-control (e.g., avoiding caffeine, tobacco) and initiatory self-control (e.g., taking medication). Formal intervention programs (e.g., cognitive behavioral therapy) tend to employ initiatory self-control (e.g., modifying physical reactions in response to biofeedback). CONCLUSIONS : Understanding the distinct types of self-control required for adherence to different interventions allows for a better conceptualization of self-management of pediatric migraine. Individuals may struggle with adherence when they have deficits in one or both types of self-control skills. Future research should consider whether self-control is associated with differential adherence patterns in pediatric migraine management.

A Randomized Controlled Neuroimaging Trial of Cognitive Behavioral Therapy for Fibromyalgia Pain.

OBJECTIVE: Fibromyalgia (FM) is characterized by pervasive pain-related symptomatology and high levels of negative affect. Mind-body treatments such as cognitive behavioral therapy (CBT) appear to foster improvement in FM via reductions in pain-related catastrophizing, a set of negative, pain-amplifying cognitive and emotional processes. However, the neural underpinnings of CBT's catastrophizing-reducing effects remain uncertain. This randomized controlled mechanistic trial was designed to assess CBT's effects on pain catastrophizing and its underlying brain circuitry. METHODS: Of 114 enrolled participants, 98 underwent a baseline neuroimaging assessment and were randomized to 8 weeks of individual CBT or a matched FM education control (EDU) condition. RESULTS: Compared with EDU, CBT produced larger decreases in pain catastrophizing post treatment (P < 0.05) and larger reductions in pain interference and symptom impact. Decreases in pain catastrophizing played a significant role in mediating those functional improvements in the CBT group. At baseline, brain functional connectivity between the ventral posterior cingulate cortex (vPCC), a key node of the default mode network (DMN), and somatomotor and salience network regions was increased during catastrophizing thoughts. Following CBT, vPCC connectivity to somatomotor and salience network areas was reduced. CONCLUSION: Our results suggest clinically important and CBT-specific associations between somatosensory/motor- and salience-processing brain regions and the DMN in chronic pain. These patterns of connectivity may contribute to individual differences (and treatment-related changes) in somatic self-awareness. CBT appears to provide clinical benefits at least partially by reducing pain-related catastrophizing and producing adaptive alterations in DMN functional connectivity.

Perfectionism as a predictor of change in digital self-guided interventions for public speaking anxiety in adolescents: A secondary analysis of a four-armed randomized controlled trial.

Public Speaking Anxiety (PSA) interventions targeting adolescents exist; however, not all gain improvement. This exploratory study investigated whether PSA interventions resulted in a decrease in perfectionism and whether pre-treatment level and changes in perfectionism moderated the effects on PSA and social anxiety. The sample consisted of 100 adolescents from junior high schools randomized to four groups: 1) VR only (n = 20), 2) VR + online exposure program (n = 20), 3) online psychoeducation and online exposure program (n = 40), 4) waitlist and online psychoeducation program (n = 20). Self-reported symptoms of PSA, social anxiety, and perfectionism were measured at pre, week 3, post, and 3-months follow-up. Level and change in outcome variables were analyzed using latent growth curve modeling. Results revealed that the interventions did not lead to a reduction in perfectionism. Reduction in perfectionism was associated with a larger reduction in all outcome measures from post to follow-up. No interaction was found between pre-treatment perfectionism and PSA symptoms. High pre-treatment levels of perfectionism were associated with poorer outcomes on social anxiety symptoms from post to follow-up for online exposure groups. The results indicate that one should assess and address high pre-treatment levels of perfectionism during PSA interventions.

Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial.

BACKGROUND: Cognitive-Behavioral Therapy for Insomnia (CBT-I), the frontline treatment for insomnia, has yet to be evaluated among patients with primary brain tumors (PwPBT) despite high prevalence of sleep disturbance in this population. This study aimed to be the first to evaluate the feasibility, safety, and acceptability of implementing telehealth group CBT-I as well as assessing preliminary changes in subjective sleep metrics in PwPBT from baseline to follow-up. METHODS: Adult PwPBT were recruited to participate in six 90-min telehealth group CBT-I sessions. Feasibility was assessed by rates of screening, eligibility, enrollment, and data completion. Safety was measured by participant-reported adverse events. Acceptability was assessed by retention, session attendance, satisfaction, recommendation of program to others, and qualitative feedback. Participant subjective insomnia severity, sleep quality, and fatigue were assessed at baseline, post intervention, and 3-month follow-up. RESULTS: Telehealth group CBT-I was deemed safe. Following the 76% screening rate, 85% of interested individuals met study eligibility and 98% enrolled (N = 44). Ninety-one percent of enrolled participants completed measures at baseline, 79% at post intervention, and 73% at 3-month follow-up. Overall, there was an 80% retention rate for the 6-session telehealth group CBT-I intervention. All participants endorsed moderate-to-strong treatment adherence and 97% reported improved sleep. Preliminary pre-post intervention effects demonstrated improvements in subjective insomnia severity, sleep quality, and fatigue with large effect sizes. These effects were maintained at follow-up. CONCLUSIONS: Results of this proof-of-concept trial indicate that telehealth group CBT-I is feasible, safe, and acceptable among PwPBT, providing support for future randomized controlled pilot trials.

Does the effect of cognitive behavior therapy for chronic fatigue syndrome (ME/CFS) vary by patient characteristics? A systematic review and individual patient data meta-analysis.

Debate is ongoing on the efficacy of cognitive behavior therapy (CBT) for myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). With an individual patient data (IPD) meta-analysis we investigated whether the effect of CBT varied by patient characteristics. These included post-exertional malaise (PEM), a central feature of ME/CFS according to many. We searched for randomized controlled trials similar with respect to comparison condition, outcomes and treatment-protocol. Moderation on fatigue severity (Checklist Individual Strength, subscale fatigue severity), functional impairment (Sickness Impact Profile-8) and physical functioning (Short Form-36, subscale physical functioning) was investigated using linear mixed model analyses and interaction tests. PROSPERO (CRD42022358245). Data from eight trials (n = 1298 patients) were pooled. CBT showed beneficial effects on fatigue severity (ß = -11.46, 95% CI -15.13 to -7.79); p < 0.001, functional impairment (ß = -448.40, 95% CI -625.58 to -271.23); p < 0.001; and physical functioning (ß = 9.64, 95% CI 3.30 to 15.98); p < 0.001. The effect of CBT on fatigue severity varied by age (pinteraction = 0.003), functional impairment (pinteraction = 0.045) and physical activity pattern (pinteraction = 0.027). Patients who were younger, reported less functional impairments and had a fluctuating activity pattern benefitted more. The effect on physical functioning varied by self-efficacy (pinteraction = 0.025), with patients with higher self-efficacy benefitting most. No other moderators were found. It can be concluded from this study that CBT for ME/CFS can lead to significant reductions of fatigue, functional impairment, and physical limitations. There is no indication patients meeting different case definitions or reporting additional symptoms benefit less from CBT. Our findings do not support recent guidelines in which evidence from studies not mandating PEM was downgraded.