Interventions for insomnia in cancer patients and survivors-a comprehensive systematic review and meta-analysis.

BACKGROUND: Considering the persistent nature and higher prevalence of insomnia in cancer patients and survivors compared to the general population, there is a need for effective management strategies. This systematic review and meta-analysis aimed to comprehensively evaluate the available evidence for the efficacy of pharmacological and non-pharmacological interventions for insomnia in adult cancer patients and survivors. METHODS: Following the PRISMA guidelines, we analyzed data from 61 randomized controlled trials involving 6528 participants. Interventions included pharmacological, physical, and psychological treatments, with a focus on insomnia severity and secondary sleep and non-sleep outcomes. Frequentist and Bayesian analytical strategies were employed for data synthesis and interpretation. RESULTS: Cognitive-Behavioral Therapy for Insomnia (CBT-I) emerged as the most efficacious intervention for reducing insomnia severity in cancer survivors, and further demonstrated significant improvements in fatigue, depressive symptoms, and anxiety. CBT-I showed a large post-intervention effect (g = 0.86; 95%CI : 0.57-1.15) and a medium effect at follow-up (g = 0.55; 0.18-0.92). Other interventions like BWL therapy, sleep medication, melatonin, exercise, mind-body therapies, and mindfulness-based therapies showed benefits, but the evidence for their efficacy was less convincing compared to CBT-I. Brief Behavioral Therapy for Insomnia showed promise as a less burdensome alternative for patients in active cancer treatment. CONCLUSIONS: CBT-I is supported as first-line treatment for insomnia in cancer survivors, with significant benefits observed across sleep and non-sleep outcomes. The findings also highlight the potential of less intensive alternatives. The research contributes valuable insights for clinical practice and underscores the need for further exploration into the complexities of sleep disturbances in cancer patients and survivors.

Grief-focused cognitive behavioral therapies for prolonged grief symptoms: A systematic review and meta-analysis.

BACKGROUND: Studies suggest that cognitive behavioral therapies (CBTs) may be efficacious in reducing symptoms of prolonged grief disorder (PGD), but no comprehensive overview and pooled estimate of CBTs' effect on PGD in adulthood exist. We conducted a systematic review and meta-analysis of randomized controlled trials. METHOD: Studies were selected independently by two researchers based on a systematic literature search in Pubmed, APA PsycInfo, Web of Science, and Embase. Meta-analyses provided pooled effect sizes for the effects of CBTs on PGD symptoms and secondary outcomes. We explored potential moderators of effect, risk of bias of included studies, and evaluated the quality of the meta-analytical evidence through the Grading of Recommendations, Assessment, Development, and Evaluation system. RESULTS: The meta-analysis included 22 studies of 2,602 bereaved adults (averaged study Mage = 49 years). CBTs had a statistically significant medium effect on PGD symptoms at postintervention (K = 22, g = 0.65, 95% CI [0.49, 0.81]), and a large effect at follow-up (K = 7, g = 0.90, 95% CI [0.37, 1.43]). Statistically significant small-to-medium effects were found at postintervention on posttraumatic stress symptoms (K = 10, g = 0.74, 95% CI [0.49, 0.98]), depression (K = 19, g = 0.53, 95% CI [0.36, 0.71]), and anxiety (K = 9, g = 0.35, 95% CI [0.22, 0.49]). The effects on PGD remained unchanged when adjusted for possible outliers. None of the moderator analyses reached statistical significance. CONCLUSION: This review suggests that CBTs are efficacious in reducing PGD symptoms in adulthood. Generalization of findings should be done with caution due to considerable inconsistency and indirectness of meta-analytic evidence. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Through Clinicians Eyes: Use of an In-consultation Patient Decision Aid in Radiation Treatment for Early Breast Cancer. A Qualitative Study.

INTRODUCTION: Shared decision making (SDM) has become a crucial element on the political agenda and represents a vital aspect of modern healthcare. However, successful implementation of SDM highly depends on the attitude of clinicians towards SDM. The overall aim of our study was to explore the experience of oncologists and nurses with SDM using the Decision Helper, an in-consultation decision aid, at four Danish radiotherapy departments. METHODS: Semi-structured interviews were conducted with 20 clinicians. The participants were selected using purposive sampling to include nurses and oncologists, male and female, with different levels of experience with SDM and clinical work. The analysis was a data-driven, iterative process with inductive coding of all interviews and meaning condensation. RESULTS: Two main themes emerged: "Using the Decision Helper changes the consultation" and "Change of attitude among Danish oncologists." Each of the two themes included four elaborative subthemes, which are reported with supporting citations in this paper. In brief, the use of SDM and the Decision Helper should ideally be adjusted to the individual patient and depends highly on the oncologist. The participants described ambitions towards "making the right decision for this patient at this time." The healthcare system, however, has pitfalls that may hinder SDM, e.g., rigid interpretation of guideline-based recommendations. CONCLUSION: Using an in-consultation Decision Helper has the potential for individualized, structured patient engagement in decision making. There is a need for patient decision aids in clinical guidelines to ensure patient engagement in decision making.

Shared decision making with breast cancer patients - does it work? Results of the cluster-randomized, multicenter DBCG RT SDM trial.

BACKGROUND AND PURPOSE: Shared decision making (SDM) is a patient engaging process advocated especially for preference-sensitive decisions, such as adjuvant treatment after breast cancer. An increasing call for patient engagement in decision making highlights the need for a systematic SDM approach. The objective of this trial was to investigate whether the Decision Helper (DH), an in-consultation patient decision aid, increases patient engagement in decisions regarding adjuvant whole breast irradiation. MATERIAL AND METHODS: Oncologists at four radiotherapy units were randomized to practice SDM using the DH versus usual practice. Patient candidates for adjuvant whole breast irradiation after breast conserving surgery for node-negative breast cancer were eligible. The primary endpoint was patient-reported engagement in the decision process assessed with the Shared Decision Making Questionnaire (SDM-Q-9) (range 0-100, 4 points difference considered clinical relevant). Other endpoints included oncologist-reported patient engagement, decisional conflict, fear of cancer recurrence, and decision regret after 6 months. RESULTS: Of the 674 included patients, 635 (94.2%) completed the SDM-Q-9. Patients in the intervention group reported higher level of engagement (median 80; IQR 68.9 to 94.4) than the control group (71.1; IQR 55.6 to 82.2; p < 0.0001). Oncologist-reported patient engagement was higher in the invention group (93.3; IQR 82.2 to 100) compared to control group (73.3; IQR 60.0 to 84.4) (p < 0.0001). CONCLUSION: Patient engagement in medical decision making was significantly improved with the use of an in-consultation patient decision aid compared to standard. The DH on adjuvant whole breast irradiation is now recommended as standard of care in the Danish guideline.

The effect of experimental emotion induction on experimental pain: a systematic review and meta-analysis.

ABSTRACT: The idea that emotions can influence pain is generally recognized. However, a synthesis of the numerous individual experimental studies on this subject is lacking. The aim of the present systematic review and meta-analysis was to synthesize the existing evidence on the effect of experimental emotion induction on experimental pain in nonclinical adults. PsycInfo and PubMed were searched up until April 10, 2023, for studies assessing differences in self-reported pain between emotion induction groups and/or control groups or between conditions within group. Risk of bias was assessed for the individual studies. The literature search yielded 78 relevant records of 71 independent studies. When compared with control conditions, the pooled results revealed a statistically significant pain-attenuating effect of positive emotion induction (between-group: Hedges g = -0.48, 95% CI: -0.72; -0.25, K = 9; within-group: g = -0.24, 95% CI: -0.32; -0.15, K = 40), and a statistically significant pain-exacerbating effect of negative emotion induction in within-group analyses but not between-group analyses (between-group: g = -0.29, 95% CI: -0.66; 0.07, K = 10; within-group: g = 0.14, 95% CI: 0.06; 0.23, K = 39). Bayesian meta-analysis provided strong support for an effect of positive emotion induction but weak support for an effect of negative emotion induction. Taken together, the findings indicate a pain-attenuating effect of positive emotion induction, while the findings for negative emotion induction are less clear. The findings are discussed with reference to theoretical work emphasizing the role of motivational systems and distraction for pain. Limitations include considerable heterogeneity across studies limiting the generalizability of the findings.

Examining the efficacy of treatments for arm lymphedema in breast cancer survivors: an overview of systematic reviews with meta-analyses.

Background: Lymphedema affects one in six breast cancer survivors making it a global healthcare challenge. There is considerable debate about the efficacy of different treatments for lymphedema. We aimed to summarize the current evidence for treatments for lymphedema in breast cancer survivors. Methods: In this overview of systematic reviews with meta-analyses (SRMAs), five databases were searched for SRMAs of randomised controlled trials (RCTs) reporting effects of medications, surgery, exercise, laser therapy, acupuncture, kinesio taping, or complex decongestive physiotherapy (CDP) for breast cancer-related lymphedema published from database inception up to March 7, 2023. Data extraction was performed for the SRMAs and RCTs, and SRMAs were appraised with AMSTAR2. Random effects meta-analyses of the RCTs provided estimates of the pooled effects sizes (Hedges' g) for each treatment modality. This study is registered with PROSPERO, CRD42020184813. Findings: 1569 studies were identified by the search and eighteen SRMAs with 51 RCTs were included, investigating manual lymphatic drainage (MLD), compression pump, exercise, kinesio taping, laser, and acupuncture. Overall, the methodological quality of the SRMAs was low. SRMAs reached different conclusions for all treatment modalities, except for kinesio taping where the two SRMAs found no effect. The analysis of 40 RCTs with 1970 participants revealed a small effect across all interventions compared to any control (g = 0.20, p = 0.047, I2 = 0.79), corresponding to volume reductions of 119.7 ml (95% CI 135-104) and 88.0 ml (95% CI 99-77) in the intervention and control groups, respectively, and a small effect of exercise (g = 0.26, p = 0.022, I2 = 0.44). The between-group differences in volume reduction were small and did not reach statistical significance for any one treatment modality. Interpretation: Based on the available data, there is no evidence of superiority of any one treatment on volume reduction nor any solid research refuting these treatments. Thus, definitive conclusions to inform clinical practice about the efficacy of these treatments cannot be drawn. Due to poor-quality evidence, more research is needed to untangle the efficacy of each treatment component for different stages of lymphedema. Funding: Danish Cancer Society.

Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study.

BACKGROUND: Colorectal cancer with peritoneal metastases can be treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Treatment may result in biopsychosocial late effects (LEs). We explored the frequency and severity of the following biopsychosocial LEs: anxiety, depression, fear of cancer recurrence (FCR), insomnia, fatigue, cognitive impairment, and pain, and evaluated their impact on quality of life (QoL). METHOD: This was a national prospective cohort study screening for LEs during the period January 2021-May 2023. Patients completed the following questionnaires: General Anxiety Disorder-7, Patient Health Questionnaire-9, FCR Inventory-Short Form, Insomnia Severity Index, Functional Assessment of Chronic Illness Therapy-Fatigue, cognitive impairment (six items from the European Organisation for Research and Treatment of Cancer Item Library), and the Rectal Cancer Pain Score. Preregistration was completed at ClinicalTrials.gov (NCT04956107). RESULT: In total, 99 patients were included. The mean age was 61 years and 57% were women. At 3 months after surgery, the frequent LEs were fatigue (72%), FCR (58%), and pain (48%), and at 12 months after surgery, the frequent LEs were FCR (65%), fatigue (40%), and insomnia (33%). More than half of the patients (54%) reported at least two LEs after 12 months. Patients with moderate-to-severe LEs reported a lower QoL than patients with no/mild LEs. Patients with no/mild LEs had a similar QoL as the Danish norm population. CONCLUSION: Biopsychosocial LEs were prevalent. The QoL of patients reporting LEs in the worst severity categories was negatively impacted. Screening and treatment for these LEs should be a focus in cancer survivor follow-up.

Social inequality in cancer survivorship: Educational differences in health-related quality of life among 27,857 cancer survivors in Denmark.

BACKGROUND: With a growing population of cancer survivors in Denmark, the evaluation of health-related quality of life (HRQoL) has become increasingly important. We describe variations in HRQoL between educational groups in a national population of cancer survivors. METHODS: We conducted a cross-sectional questionnaire study among breast, prostate, lung, and colon cancer survivors diagnosed in 2010-2019 in Denmark. We used the EORTC QLQ-C30 to assess HRQoL including physical, role, emotional, cognitive, social functioning, and symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Information on educational level and clinical data were extracted from national registers and clinical databases. Levels of impaired functioning and severe symptoms were identified using newly established thresholds for clinical importance. Multivariate logistic regression was used to examine associations between education and HRQoL. All statistical tests were 2-sided. RESULTS: In total, 27,857 (42%) participated in the study. Up to 72% and 75% of cancer survivors with short education (≤9 years) reported impaired functioning and severe symptoms, respectively. Cancer survivors with short compared to long education (>12 years) were more likely to report impaired functioning and severe symptoms, with for example significantly higher odds ratios (ORs) for impaired physical function (breast OR = 2.41, 99% CI = 2.01-2.89; prostate OR = 1.81, 99% CI = 1.48-2.21; lung OR = 2.97, 99% CI = 1.95-4.57; and colon cancer OR = 1.69, 99% CI = 1.28-2.24). CONCLUSIONS: Cancer survivors with short education are at greater risk of impaired HRQoL than survivors with long education 2-12 years after diagnosis. This underscores the need for systematic screening and symptom management in cancer aftercare, in order to reach all cancer survivors, also cancer survivors with short education.

ConquerFear-Group: A randomized controlled trial of an online-delivered group-based psychological intervention for fear of cancer recurrence in breast cancer survivors.

OBJECTIVE: Fear of cancer recurrence (FCR) is a distressing concern among cancer survivors. Interventions to address FCR need to be effective but also accessible and low cost. This randomized controlled trial evaluated the efficacy of an online group-based psychological intervention for FCR (ConquerFear-Group). METHODS: Eligible breast cancer (BC) survivors had completed primary treatment 3 months-5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). Participants were randomized to online ConquerFear-Group (focusing on metacognitive strategies, values-clarification, and education about follow-up behavior) or online group-based relaxation training (active control). Questionnaires were completed at baseline (T1), 1 week post-intervention (T2), three (T3) and six (T4) months later. The primary outcome was FCR (FCRI total). A number of secondary and process outcomes were also collected. Treatment effects were evaluated with mixed linear models. RESULTS: Of 866 eligible BC survivors, 475 (55%) completed the FCR screening, and 85 (18%) were randomized to ConquerFear-Group or relaxation training (2 × 6 groups). Compared with control participants, ConquerFear-Group participants experienced larger reductions in FCR (Cohen's d = 0.47, p = 0.001) and FCR severity (d = 0.57, p < 0.001), as well as mindfulness and decentering from baseline through follow-up, and improvements in emotion regulation (T2), worry (T2, T3) and rumination (T2) at some time points. CONCLUSIONS: The results demonstrated statistically significant and stable effects of ConquerFear-Group on FCR that were maintained over a 6-month period. It is suggested to investigate the program in a real-life setting, where a pragmatic trial can further demonstrate feasibility and effectiveness.

Psychological intervention for gambling disorder: A systematic review and meta-analysis.

Background and aims: Increasingly, gambling features migrate into non-gambling platforms (e.g., online gaming) making gambling exposure and problems more likely. Therefore, exploring how to best treat gambling disorder (GD) remains important. Our aim was to review systematically and quantitatively synthesize the available evidence on psychological intervention for GD. Methods: Records were identified through searches for randomized controlled trials (RCTs) evaluating psychological intervention for GD via six academic databases without date restrictions until February 3, 2023. Study quality was assessed with the revised Cochrane risk-of-bias tool for randomized trials (RoB2). Primary outcomes were GD symptom severity and remission of GD, summarized as Hedges' g and odds ratios, respectively. The study was preregistered in PROSPERO (#CRD42021284550). Results: Of 5,541 records, 29 RCTs (3,083 participants analyzed) were included for meta-analysis of the primary outcomes. The efficacy of psychological intervention across modality, format and mode of delivery corresponded to a medium effect on gambling severity (g = -0.71) and a small effect on remission (OR = 0.47). Generally, risk of bias was high, particularly amongst early face-to-face interventions studies. Discussion and conclusions: The results indicate that psychological intervention is efficacious in treating GD, with face-to-face delivered intervention producing the largest effects and with strongest evidence for cognitive behavioral therapy. Much remains to be known about the long-term effects, and investigating a broader range of treatment modalities and digital interventions is a priority if we are to improve clinical practice for this heterogeneous patient group.

Caregiver fear of cancer recurrence: A systematic review and meta-analysis of quantitative studies.

OBJECTIVE: Fear of cancer recurrence (FCR) is reported by both cancer survivors and caregivers however less is known about caregiver FCR. This study aimed to (a) conduct a meta-analysis to compare survivor and caregiver FCR levels; (b) examine the relationship between caregiver FCR and depression, and anxiety; (c) evaluate psychometric properties of caregiver FCR measures. METHODS: CINAHL, Embase, PsychINFO and PubMed were searched for quantitative research examining caregiver FCR. Eligibility criteria included caregivers caring for a survivor with any type of cancer, reporting on caregiver FCR and/or measurement, published in English-language, peer-review journals between 1997 and November 2022. The COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) taxonomy was used to evaluate content and psychometric properties. The review was pre-registered (PROSPERO ID: CRD42020201906). RESULTS: Of 4297 records screened, 45 met criteria for inclusion. Meta-analysis revealed that caregivers reported FCR levels as high as FCR amongst survivors, with around 48% of caregivers reporting clinically significant FCR levels. There was a strong correlation between anxiety and depression and medium correlation with survivor FCR. Twelve different instruments were used to measure caregiver FCR. Assessments using the COSMIN taxonomy revealed few instruments had undergone appropriate development and psychometric testing. Only one instrument met 50% or more of the criteria, indicating substantial development or validation components were missing in most. CONCLUSIONS: Results suggest FCR is as often a problem for caregivers as it is for survivors. As in survivors, caregiver FCR is associated with more severe depression and anxiety. Caregiver FCR measurement has predominately relied on survivor conceptualisations and unvalidated measures. More caregiver-specific research is urgently needed.

Psychological and behavioral symptoms in patients with melanoma: A systematic review and meta-analysis.

OBJECTIVE: Improved survival rates have made it increasingly important for clinicians to focus on cancer survivorship issues affecting the quality of life of melanoma patients. To provide a comprehensive overview of the disease and treatment-related issues affecting such patients, we conducted a systematic review and meta-analysis of the literature to estimate the prevalence of symptoms of depression, anxiety, fatigue, sleep disturbance, and cognitive problems among melanoma patients, both uveal and cutaneous, before, during and after treatment. METHODS: The review was preregistered with PROSPERO (#CRD42020189847) and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search of the literature published up until June 2022 was undertaken using PubMed, PsycInfo, the Cochrane Library, and CINAHL. Two independent reviewers screened 1418 records and quality-rated included studies. The reported prevalence rates of symptoms were pooled using a random-effects model. RESULTS: Sixty-six studies including a total of 12,400 melanoma patients published between 1992 and 2022 were included. Pooled prevalence rates ranged from 6% to 16% for depression and 7%-30% for anxiety across diagnoses (uveal and cutaneous melanoma) and assessment time points. One third of the patients (35%) reported clinically significant fatigue, 20%-44% had cognitive complaints, while prevalence of sleep disturbance was not reported. Quality assessment indicated that 80% of the studies were of good quality. CONCLUSION: A large body of research shows that depression and anxiety symptoms are prevalent in melanoma patients before, during and after treatment. However, research examining other symptoms known to affect quality of life, such as fatigue, sleep disturbances, and cognitive problems, is still needed.

Educational differences in healthcare use among survivors after breast, prostate, lung, and colon cancer - a SEQUEL cohort study.

BACKGROUND: Many cancer survivors experience late effects after cancer. Comorbidity, health literacy, late effects, and help-seeking behavior may affect healthcare use and may differ among socioeconomic groups. We examined healthcare use among cancer survivors, compared with cancer-free individuals, and investigated educational differences in healthcare use among cancer survivors. METHODS: A Danish cohort of 127,472 breast, prostate, lung, and colon cancer survivors from the national cancer databases, and 637,258 age- and sex-matched cancer-free individuals was established. Date of entry was 12 months after diagnosis/index date (for cancer-free individuals). Follow-up ended at death, emigration, new primary cancer, December 31st, 2018, or up to 10 years. Information about education and healthcare use, defined as the number of consultations with general practitioner (GP), private practicing specialists (PPS), hospital, and acute healthcare contacts 1-9 years after diagnosis/index date, was extracted from national registers. We used Poisson regression models to compare healthcare use between cancer survivors and cancer-free individuals, and to investigate the association between education and healthcare use among cancer survivors. RESULTS: Cancer survivors had more GP, hospital, and acute healthcare contacts than cancer-free individuals, while the use of PPS were alike. One-to-four-year survivors with short compared to long education had more GP consultations (breast, rate ratios (RR) = 1.28, 95% CI = 1.25-1.30; prostate, RR = 1.14, 95% CI = 1.10-1.18; lung, RR = 1.18, 95% CI = 1.13-1.23; and colon cancer, RR = 1.17, 95% CI = 1.13-1.22) and acute contacts (breast, RR = 1.35, 95% CI = 1.26-1.45; prostate, RR = 1.26, 95% CI = 1.15-1.38; lung, RR = 1.24, 95% CI = 1.16-1.33; and colon cancer, RR = 1.35, 95% CI = 1.14-1.60), even after adjusting for comorbidity. One-to-four-year survivors with short compared to long education had less consultations with PPS, while no association was observed for hospital contacts. CONCLUSION: Cancer survivors used more healthcare than cancer-free individuals. Cancer survivors with short education had more GP and acute healthcare contacts than survivors with long education. To optimize healthcare use after cancer, we need to better understand survivors' healthcare-seeking behaviors and their specific needs, especially among survivors with short education.

The effect of air quality on sleep and cognitive performance in school children aged 10-12 years: a double-blinded, placebo-controlled, crossover trial.

OBJECTIVES: To investigate the effect of CO2 during sleep on next-morning cognitive performance in young schoolchildren, the authors performed a double-blind fully balanced crossover placebo-controlled study. MATERIAL AND METHODS: The authors included 36 children aged 10-12 years in the climate chamber. The children slept at 21°C in 6 groups each at 3 different conditions separated by 7 days in a random order. Conditions were as follows: high ventilation with CO2 at 700 ppm, high ventilation with added pure CO2 at 2000-3000 ppm, and reduced ventilation with CO2 at 2-3000 ppm and bioeffluents. Children were subjected to a digital cognitive test battery (CANTAB) in the evening prior to sleep and on the next morning after breakfast. Sleep quality was monitored with wrist actigraphs. RESULTS: There were no significant exposure effects on cognitive performance. Sleep efficiency was significantly lower at high ventilation with CO2 at 700 ppm which is considered to be a chance effect. No other effects were seen, and no relation between air quality during sleep and next-morning cognitive performance was observed in the children emitting an estimated 10 lCO2/h per child. CONCLUSIONS: No effect of CO2 during sleep was found on next day cognition. The children were awakened in the morning, and spent from 45-70 min in well-ventilated rooms before they were tested. Hence, it cannot be precluded that the children have benefitted from the good indoor air quality conditions before and during the testing period. The slightly better sleep efficiency during high CO2 concentrations might be a chance finding. Hence, replication is needed in actual bedrooms controlling for other external factors before any generalizations can be made. Int J Occup Med Environ Health. 2023;36(2):177-91.

Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark.

INTRODUCTION: One in five breast cancer (BC) survivors are affected by persistent pain years after completing primary treatment. While the efficacy of psychological interventions for BC-related pain has been documented in several meta-analyses, reported effect sizes are generally modest, pointing to a need for optimisation. Guided by the Multiphase Optimization Strategy, the present study aims to optimise psychological treatment for BC-related pain by identifying active treatment components in a full factorial design. METHODS AND ANALYSIS: The study uses a 2×3 factorial design, randomising 192 women with BC-related pain (18-75 years) to eight experimental conditions. The eight conditions consist of three contemporary cognitive-behavioural therapy components, namely: (1) mindful attention, (2) decentring, and (3) values and committed action. Each component is delivered in two sessions, and each participant will receive either zero, two, four or six sessions. Participants receiving two or three treatment components will be randomised to receive them in varying order. Assessments will be conducted at baseline (T1), session by session, every day for 6 days following the first session in each treatment component, at post-intervention (T2) and at 12-week follow-up (T3). Primary outcomes are pain intensity (Numerical Rating Scale) and pain interference (Brief Pain Inventory interference subscale) from T1 to T2. Secondary outcomes are pain burden, pain quality, pain frequency, pain catastrophising, psychological distress, well-being and fear of cancer recurrence. Possible mediators include mindful attention, decentring, and pain acceptance and activity engagement. Possible moderators are treatment expectancy, treatment adherence, satisfaction with treatment and therapeutic alliance. ETHICS AND DISSEMINATION: Ethical approval for the present study was received from the Central Denmark Region Committee on Health Research Ethics (no: 1-10-72-309-40). Findings will be made available to the study funders, care providers, patient organisations and other researchers at international conferences, and published in international, peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05444101).

Comparing the efficacy of mindfulness-based therapy and cognitive-behavioral therapy for depression in head-to-head randomized controlled trials: A systematic review and meta-analysis of equivalence.

BACKGROUND: While Cognitive Behavioral Therapy (CBT) is recommended as first-line treatment for depression, a significant minority do not show an adequate treatment response. Despite evidence for the efficacy of Mindfulness-Based Therapies (MBT) both in treating current depression and preventing relapse, it remains unknown whether MBT and CBT are equivalent in the treatment of current depression. METHODS: Five databases were searched for randomized controlled trials (RCTs) directly comparing MBT with CBT and including depression as primary or secondary outcome. RESULTS: When pooling the results of 30 independent RCTs with a total of 2750 participants, MBT and CBT were statistically significantly equivalent at both post-intervention (Hedges's g = -0.009; p < .001) and follow-up (g = -0.033; p = .001). Supplementary Bayesian analyses provided further support for the alternative hypothesis of no difference between MBT and CBT. When exploring possible sources of heterogeneity, the differences at follow-up were smaller between CBT and mindfulness-based cognitive therapy (MBCT) than between CBT and mindfulness-based stress-reduction (MBSR) (Slope = 0.37;p = .022). CONCLUSION: The currently available evidence suggests that that MBT and CBT are equally efficacious in treating current adult depression. It remains unclear whether the similar effects of the two intervention types are due to different mechanisms or common factors.