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.

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress.

BACKGROUND: Caregivers of patients with cancer play a crucial role in the health of the person they care for, and in the healthcare system at large. Family caregivers receive minimal support, despite being at greater risk for anxiety and depression than patients themselves. Cognitive behavioral therapy (CBT), an effective therapy for anxiety and depression, has shown mixed efficacy when delivered to cancer caregivers. Emotion Regulation Therapy (ERT), a contemporary CBT, may uniquely target processes underlying distress associated with caregiving. Therefore, we adapted both CBT and ERT to target the needs of caregivers (i.e., CBT-C and ERT-C) and are conducting a multi-site randomized trial to examine the comparative efficacy of these interventions. METHODS: Family cancer caregivers (n = 200) reporting distress related to caregiving are recruited from two academic cancer centers and randomly assigned to either ERT-C or CBT-C. Caregivers in both interventions engage in eight weekly one-hour sessions by videoconference with a trained interventionist. Caregiver participants complete study assessments at baseline, post-treatment, 3-and 6-months follow-up. Patients of each caregiver can also enroll in the study and complete assessments at baseline and 3-months follow-up. Outcome measures include psychosocial constructs such as anxiety, depression, quality of life, as well as proposed mechanistic constructs and salivary markers of stress and inflammation. CONCLUSIONS: The results of this study will advance the science of caregiving interventions in cancer by addressing a critical gap in our ability to mitigate anxiety and depression in caregivers, as well as further our understanding of how these changes may influence patients' outcomes.

ConquerFear-group: Feasibility study with pilot results of a psychological intervention for fear of cancer recurrence delivered in groups.

OBJECTIVE: ConquerFear has been found to effectively reduce fear of cancer recurrence (FCR). Group interventions may be particularly effective for the treatment of FCR and could lower overall costs. Our objectives were therefore to adapt ConquerFear into a group format (ConquerFear-Group, CF-G), and to evaluate its feasibility, acceptability, and preliminary efficacy. METHODS: Eligible patients had completed treatment for breast cancer 3 months to 5 years previously, were ≥18 years, and scored ≥22 on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). The manual was first evaluated with seven patients (Pilot 1), adjusted in accordance with feedback from the patients, therapists, and the original ConquerFear developers. After further evaluation with eight patients (Pilot 2), and subsequent adjustments, the preliminary efficacy of the final manual was evaluated with 27 patients, randomized in blocks to CF-G (N = 13) or active control (AC) (relaxation training) (N = 14) (Pilot 3). The primary outcome was the FCRI total score. Secondary outcomes included general distress, quality-of-life, and process outcomes pertaining to metacognitions, decentering, and worry. All measures were completed at baseline, post-treatment, and at 3 and 6 months follow-up. RESULTS: Adjustments of the original ConquerFear manual (Pilot 1 and 2) included changes in the order of treatment components, simplified exercises, and shortened homework. Compared with ACs, CF-G participants reported greater reductions in FCRI total scores from baseline to post-treatment (Hedges's g = 0.59, p = 0.004), 3 months (g = 0.50, p = 0.026), and 6 months later (g = 0.93, p = 0.043). Differences corresponding to medium-to-large effect sizes (Pilot 3). Although non-significant, group differences concerning reductions in general distress and maladaptive metacognitions corresponded to small-to-medium effect sizes (g = 0.40-0.61; ps = 0.40-0.61). CONCLUSIONS: CF-G appears feasible and potentially efficacious in treating FCR in a breast cancer population. These preliminary results are promising but need to be confirmed in a larger randomized trial.

Moderators and mediators of emotion regulation therapy for psychologically distressed caregivers of cancer patients: secondary analyses from a randomized controlled trial.

BACKGROUND: Being an informal caregiver (IC) of a cancer patient is often associated with psychological distress. We have recently, in a randomized controlled trial (RCT), demonstrated efficacy of Emotion Regulation Therapy for ICs (ERT-C), evidenced as lower levels of psychological distress. Such efficacy demonstration is important, but a crucial step in improving treatments for the IC population is the identification of moderators (i.e., for whom the treatment works) and mediators (i.e., the drivers of the detected effect). MATERIAL AND METHODS: In a sample of 65 psychologically distressed ICs (combining participants who received immediate and delayed treatment in the RCT); we investigated age, gender, and homework completion as moderators of treatment outcome. Proposed mediators were derived from the ERT model and included mindfulness, emotion regulation dysfunction, decentering, and cognitive reappraisal. RESULTS AND CONCLUSIONS: The strongest moderation effect was found for homework completion, predicting improvements on psychological distress. Correlational mediation analyses generally supported the ERT model. However, temporal precedence was only established for the association between decentering and worry, where a bidirectional relation was revealed. Homework thus emerged as an important aspect of ERT-C and, albeit a bidirectional relationship, changes in decentering may precede changes in worry. Future trials should ensure the robustness of these results, hone the specificity of process measures, and further investigate the causal timeline of change.

The impact of emotion regulation therapy on emotion differentiation in psychologically distressed caregivers of cancer patients.

BACKGROUND AND OBJECTIVES: Emotion differentiation is considered adaptive because differentiated emotional experiences are believed to promote access to the information that emotions carry, enabling context-appropriate emotion regulation. In the present study, secondary analyses from a recent randomized controlled trial (O'Toole et al., 2019) were conducted to investigate whether emotion differentiation can improve as a result of psychotherapy and whether improvements in emotion differentiation are associated with reduced distress. DESIGN AND METHODS: A total of 81 distressed caregivers of cancer patients were randomized to Emotion Regulation Therapy (ERT), an intervention aimed at improving emotion differentiation and facilitating healthy emotion regulation, or a waitlist condition. Emotion differentiation scores could be calculated for 54 caregivers. RESULTS: Repeated measures ANOVAs revealed that ERT led to significant improvements in negative (η2 = 0.21, p = .012), but not positive emotion differentiation (η2 = <0.01, p = .973). Correlation analyses showed that improvements in negative emotion differentiation were not associated with changes in distress. CONCLUSIONS: The results suggest that negative emotion differentiation can improve as a result of psychotherapy. Further research is needed to clarify how improvements in emotion differentiation following therapeutic interventions relate to treatment outcomes such as distress.Trial registration: ClinicalTrials.gov identifier: NCT02322905.

A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients.

BACKGROUND: Previous cognitive behavioral therapies for informal caregivers (ICs) have produced negligible effects. The purpose of this study was to evaluate, in a randomized controlled trial, the efficacy of Emotion Regulation Therapy adapted for caregivers (ERT-C) on psychological and inflammatory outcomes in psychologically distressed ICs and the cancer patients cared for. METHODS: A total of 81 ICs with elevated psychological distress were randomly assigned to ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment. In 52 cases, the patient cared for by the IC was included. Patients did not receive ERT-C. Both the ERT-C and waitlist groups were followed 3 and 6 months post-treatment. Data were analyzed with multilevel models, and P values were two-sided. RESULTS: Compared with ICs in the waitlist condition, ICs in the ERT-C condition experienced medium to large statistically significant reductions in psychological distress (Hedge's g = 0.86, 95% confidence interval [CI] = 0.40 to 1.32, P < .001), worry (g = 0.96, 95% CI = 0.50 to 1.42, P < .001), and caregiver burden (g = 0.53, 95% CI = 0.10 to 1.99, P = .007) post-treatment. No statistically significant effects were found for rumination (g = 0.24, 95% CI = -0.20 to 0.68, P = .220). Results concerning caregiver burden were maintained through 6 months follow-up. Although the effects on psychological distress and worry diminished, their end-point effects remained medium to large. No statistically significant effects on systemic inflammation were detected (C-reactive protein: g = .17, 95% CI = -0.27 to 0.61, P = .570; interleukin-6: g = .35, 95% CI = -0.09 to 0.79, P = .205; tumor necrosis factor-alpha: g = .11, 95% CI = -0.33 to 0.55, P = .686). Patients whose ICs attended ERT-C experienced a large increase in quality of life post-treatment (g = 0.88, 95% CI = 0.18 to 1.58, P = .017). CONCLUSIONS: To our knowledge, this is the first randomized controlled trial evaluating the efficacy of ERT-C for ICs. Given the previous disappointing effects of other cognitive behavioral therapies for this population, the present findings are very encouraging. Identifying ICs with elevated psychological distress and providing them with relevant psychotherapy appears an important element of comprehensive cancer care.

Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress.

Informal caregivers (ICs) are integral to care provided to patients facing life-threatening or incurable illnesses. This responsibility causes considerable burden, as approximately one half of ICs report clinically significant symptoms of depression and/or anxiety that persist when left untreated. Psychosocial interventions containing efficacious treatment principles (e.g., cognitive behavior therapy [CBT]) show disappointing results in reducing anxiety and depression in ICs. This may reflect failure of these interventions to specifically target crucial mechanisms underlying the central feature of distress caused by the patient's illness-notably, perseverative negative thinking (PNT). Emotion Regulation Therapy (ERT) is an efficacious CBT developed to explicitly target mechanisms underlying PNT and the emotional concomitants that arise in response to stressful situations. This open trial was conducted to evaluate the acceptability and initial efficacy of ERT adapted to the experience of cancer ICs (ERT-C). Thirty-one ICs provided informed consent and completed eight weekly individual sessions of ERT-C. Participants completed self-report measures of depression and anxiety symptoms, PNT, emotion regulation deficits, and caregiver burden before and after treatment. ERT-C was well tolerated as indicated by 22 treatment completers and feedback provided in exit interviews. ICs demonstrated reduced depression and anxiety symptoms, PNT, and emotion regulation deficits with moderate to large effect sizes (Hedge's g range: 0.36-0.92). Notably, caregiver burden was not reduced but ICs expressed more ability to confront caregiving-related challenges. Findings offer promising but preliminary support for ERT-C as a conceptual model and treatment modality for distressed cancer ICs.

Effect of Psychological Intervention on Fear of Cancer Recurrence: A Systematic Review and Meta-Analysis.

PURPOSE: Fear of cancer recurrence (FCR) is a significantly distressing problem that affects a substantial number of patients with and survivors of cancer; however, the overall efficacy of available psychological interventions on FCR remains unknown. We therefore evaluated this in the present systematic review and meta-analysis. METHODS: We searched key electronic databases to identify trials that evaluated the effect of psychological interventions on FCR among patients with and survivors of cancer. Controlled trials were subjected to meta-analysis, and the moderating influence of study characteristics on the effect were examined. Overall quality of evidence was evaluated using the GRADE system. Open trials were narratively reviewed to explore ongoing developments in the field (PROSPERO registration no.: CRD42017076514). RESULTS: A total of 23 controlled trials (21 randomized controlled trials) and nine open trials were included. Small effects (Hedges's g) were found both at postintervention (g = 0.33; 95% CI, 0.20 to 0.46; P < .001) and at follow-up (g = 0.28; 95% CI, 0.17 to 0.40; P < .001). Effects at postintervention of contemporary cognitive behavioral therapies (CBTs; g = 0.42) were larger than those of traditional CBTs (g = 0.24; ß = .22; 95% CI, .04 to .41; P = .018). At follow-up, larger effects were associated with shorter time to follow-up (ß = -.01; 95% CI, -.01 to -.00; P = .027) and group-based formats (ß = .18; 95% CI, .01 to .36; P = .041). A GRADE evaluation indicated evidence of moderate strength for effects of psychological intervention for FCR. CONCLUSION: Psychological interventions for FCR revealed a small but robust effect at postintervention, which was largely maintained at follow-up. Larger postintervention effects were found for contemporary CBTs that were focused on processes of cognition-for example, worry, rumination, and attentional bias-rather than the content, and aimed to change the way in which the individual relates to his or her inner experiences. Future trials could investigate how to further optimize and tailor interventions to individual patients' FCR presentation.

The association between anxiety, traumatic stress, and obsessive-compulsive disorders and chronic inflammation: A systematic review and meta-analysis.

BACKGROUND: Anxiety is characterized by prolonged preparation for real or perceived threat. This may manifest both as psychological and physiological activation, ultimately leading to greater risk for poor health. Chronic inflammation may play an integral role in this relationship, given the influential role that it has in chronic illness. The aim of this meta-analysis is to examine levels of chronic inflammation, measured by inflammatory cytokines and C-reactive protein, in people with anxiety disorders, PTSD (posttraumatic stress disorder), or obsessive-compulsive disorder compared to healthy controls. Several moderating variables, including specific diagnosis and depression comorbidity, were also assessed. METHODS: Seventy six full-text articles were screened for eligibility with 41 studies ultimately included in analysis. RESULTS: Results demonstrated a significant overall difference between healthy controls (HCs) and people with anxiety disorders in pro-inflammatory cytokines (P = 0.013, Hedge's g = -0.39), which appears to be largely driven by interleukin-1ß (IL-1ß; P = 0.009, Hedge's g = -0.50), IL-6 (P < 0.001, Hedge's g = -0.93), and tumor necrosis factor-α (P = 0.030, Hedge's g = -0.56). Moderation analyses revealed a moderating effect of diagnosis (P = 0.050), as only individuals with PTSD demonstrated differences in inflammation between HCs (P = 0.004, Hedge's g = -0.68). CONCLUSIONS: These data demonstrate the association between inflammatory dysregulation and diagnoses associated with chronic, impactful, and severe anxiety and provides insight into the way that anxiety, and in particular PTSD, is related to certain inflammatory markers. In doing so, these findings may provide an initial step in disentangling the relationship between anxiety and basic health processes.

Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients.

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia.

Mindfulness-based Cognitive Therapy and Persistent Pain in Women Treated for Primary Breast Cancer: Exploring Possible Statistical Mediators: Results From a Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to investigate possible statistical mediators in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) on pain intensity in women treated for primary breast cancer. MATERIALS AND METHODS: The sample consisted of 129 women treated for breast cancer, presenting with persistent pain, who were randomly assigned to MBCT or a wait-list control. We previously reported a statistically significant and robust effect of MBCT on pain intensity (11-point numeric rating scale), which was included as the primary outcome. The proposed mediators were mindfulness (the Five Facet Mindfulness Questionnaire), self-compassion (the Short-Form Self-Compassion Scale), and pain catastrophizing (the Pain Catastrophizing Scale). Measurement points included baseline (T1), postintervention (T2), and 3- (T3) and 6-month (T4) follow-ups. All indirect effects of the mediators were tested in separate Multilevel Models, using the product-of-coefficients approach with bias-corrected confidence intervals (95% BSCI). The statistically significant mediators were then included in a multiple mediator model. RESULTS: Statistically significant indirect effects were found for mindfulness nonreactivity (B=-0.17, BSCI [-0.32 to -0.04]) and pain catastrophizing (B=-0.76, BSCI [-1.25 to -0.47]). No statistically significant indirect effect was found for self-compassion (B=-0.09, BSCI [-0.30 to 0.04]). In a multiple mediator model, including mindfulness nonreactivity and pain catastrophizing, only pain catastrophizing remained statistically significant (B=-0.72, BSCI [-1.19 to -0.33]), explaining 78% of the effect. DISCUSSION: The results of the present study may have clinical implications. An increased focus on the proposed mediators may optimize the clinical use of MBCT for persistent pain in women treated for breast cancer.

Cognitive behavioral therapies for informal caregivers of patients with cancer and cancer survivors: a systematic review and meta-analysis.

OBJECTIVE: Informal caregivers (ICs) of patients with cancer and cancer survivors report a number of psychological and physical complaints because of the burden associated with providing care. Given the documented effect of Cognitive Behavioral Therapy (CBT) on ICs' common psychological complaints, such as anxiety and depression, the objective was to conduct a meta-analysis on the effect of CBTs for adult ICs. METHODS: A literature search was conducted in order to identify all intervention studies on adult ICs that employed at least one therapeutic component defined as a CBT component. RESULTS: Literature searches revealed 36 unique records with sufficient data. These studies were subjected to meta-analyses using random effects models. A small, statistically significant effect of CBTs (Hedge's g = 0.08, p = 0.014) was revealed, which disappeared when randomized controlled trials were evaluated alone (g = 0.04, p = 0.200). A number of variables were explored as moderators. Only the percentage of female participants was positively associated with the effect size. CONCLUSIONS: Based on the negligible effect of CBTs across outcomes, future studies should consider moving beyond traditional CBT methods as these do not appear efficacious. It is suggested that future interventions orient towards advances in the basic affective sciences and derived therapies in order to better understand and treat the emotional struggles experienced by ICs. © 2016 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.

The effect of expressive writing intervention on psychological and physical health outcomes in cancer patients--a systematic review and meta-analysis.

OBJECTIVE: This study aimed to evaluate the effectiveness of expressive writing intervention (EWI) for improving psychological and physical health in cancer patients and survivors. METHODS: We searched databases and existing reviews for randomized controlled studies published between 1986 and 2014 that evaluated the effects of EWI on psychological and physical health outcomes. We computed and combined effect sizes and examined the role of methodological characteristics. RESULTS: From 223 unique citations, we identified 16 independent randomized controlled trials published from 1999 to 2014, examining the effect of EWI on a range of psychological and physical health outcomes. No statistically significant effects were found for any of the individual or combined psychological (Hedges's g: 0.04; 95% CI, -0.06 to 0.14; p = 0.42), physical (0.08; 95% CI, -0.05 to 0.20; p = 0.22), or quality-of-life outcomes (0.09; 95% CI, -0.05 to 0.24; p = 0.22). The results were unaffected by differences in study characteristics, for example, type of control condition, study setting, cancer type, and overall study quality ratings. Results from a subset of studies indicated a possible moderating effect of social constraints, suggesting that participants experiencing low levels of emotional support may be more likely to benefit from EWI. CONCLUSIONS: Our results do not support the general effectiveness of EWI in cancer patients and survivors. However, given the practical and inexpensive intervention, it is possible that even small effects in subgroups of patients could be clinically relevant, and future studies are recommended to test the effects of potential moderators, including pre-intervention distress levels and context-dependent factors such as emotional support.