Defining and operationalizing personalized psychological treatment - a systematic literature review.

This systematic literature review aimed to propose a definition of personalized psychological treatment and to suggest how the definition can be operationalized. PsycINFO, Cochrane Library, MEDLINE and EMBASE were searched up to 11 December 2023 for studies in which a definition of personalized psychological treatment was included or a systematic operationalization of personalized psychological treatment was described. Based on a narrative synthesis of the collected definitions, summary categories were developed that informed the proposed definition. Operationalizations were described according to what aspect of treatment, how and when treatment was personalized. The extent to which the operationalizations deviated from the proposed definition was assessed. Thirty-four studies with definitions and 200 with operationalizations were included. The following definition was proposed: personalized psychological treatment aims to optimize treatment outcome for the individual patient by tailoring treatment to unique or specific needs, preferences or other characteristics and includes a systematic adaptation of treatment or a differentiation between treatment strategies. Based on the operationalizations, timing of personalization, specification of the systematic approach and treatment elements that could be personalized were added to the proposed definition. Evidence-based personalization of psychological treatments can be enhanced by clear operationalization based on a comprehensive definition of personalization.

Network analysis used to investigate the interplay among somatic and psychological symptoms in patients with cancer and cancer survivors: a scoping review.

PURPOSE: Patients with cancer often experience multiple somatic and psychological symptoms. Somatic and psychological symptoms are thought to be connected and may reinforce each other. Network analysis allows examination of the interconnectedness of individual symptoms. The aim of this scoping review was to examine the current state of knowledge about the associations between somatic and psychological symptoms in patients with cancer and cancer survivors, based on network analysis. METHODS: This scoping review followed the five-stage framework of Arksey and O'Malley. The literature search was conducted in May, 2023 in PubMed, APA PsycINFO, Embase Cochrane central, and CINAHL databases. RESULTS: Thirty-two studies were included, with eleven using longitudinal data. Seventeen studies reported on the strength of the associations: somatic and psychological symptoms were associated, although associations among somatic as well as among psychological symptoms were stronger. Other findings were the association between somatic and psychological symptoms was stronger in patients experiencing more severe symptoms; associations between symptoms over time remained rather stable; and different symptoms were central in the networks, with fatigue being among the most central in half of the studies. IMPLICATIONS FOR CANCER SURVIVORS: Although the associations among somatic symptoms and among psychological symptoms were stronger, somatic and psychological symptoms were associated, especially in patients experiencing more severe symptoms. Fatigue was among the most central symptoms, bridging the somatic and psychological domain. These findings as well as future research based on network analysis may help to untangle the complex interplay of somatic and psychological symptoms in patients with cancer.

Randomized controlled trial of an individual blended cognitive behavioral therapy to reduce psychological distress among distressed colorectal cancer survivors: The COloRectal canceR distrEss reduCTion trial.

OBJECTIVE: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. METHODS: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (1:1 ratio) to receive bCBT, (14 weeks including five face-to-face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention-to-treat population was distress severity (Brief Symptom Inventory; BSI-18) immediately post-intervention (T1). RESULTS: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention-to-treat analysis, the intervention significantly reduced distress immediately post-intervention (-3.86 points, 95% CI -7.00 to -0.73) and at 7 months post-randomization (-3.88 points, 95% CI -6.95 to -0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer-specific distress were significantly lower in the intervention arm. Self-efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. CONCLUSIONS: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR6025.

Insomnia and sleep characteristics in post COVID-19 fatigue: A cross-sectional case-controlled study.

OBJECTIVE: Following COVID-19 many patients report persistent fatigue and insomnia. Given the overlapping features, insomnia can be underdiagnosed in post-COVID-19 fatigue patients. This study aimed to determine insomnia severity, prevalence of clinical insomnia and sleep characteristics of post-COVID-19 fatigue patients. Data of post-COVID-19 fatigue patients were compared with those of patients with chronic fatigue syndrome (ME/CFS), a condition resembling post-COVID-19 fatigue. METHODS: In this cross-sectional case-controlled study, insomnia severity, assessed with the Insomnia Severity Index (ISI), and prevalence of clinical insomnia (ISI score ≥ 10), were determined in patients with post-COVID-19 fatigue (n = 114) and compared with ME/CFS (n = 59) using ANCOVA and logistic regression, respectively. Linear regression analyses were used to evaluate whether mood, concentration problems, pain, fatigue (assessed with questionnaires) and diagnosis were associated with insomnia. Sleep characteristics were determined with a sleep diary and accelerometer in post-COVID-19 fatigue and compared with ME/CFS using ANCOVA. RESULTS: In patients with post-COVID-19 fatigue mean (SD) insomnia severity was 11.46 (5.7) and 64% reported clinical insomnia. Insomnia severity was significantly associated with depressive symptoms (ß = 0.49, p = 0.006) and age (ß = 0.08, p = 0.04). The mean (SD) subjective sleep duration was 7.4 (1.0) hours with a sleep efficiency of 82 (11)%. Several subjective sleep characteristics of the post-COVID-19 fatigue patients differed from ME/CFS patients; only sleep duration, being significantly shorter in post-COVID-19 fatigue patients (p = 0.003), seemed clinically relevant (d = 0.58). CONCLUSION: Insomnia severity and prevalence of clinical insomnia are high in patients with post-COVID-19 fatigue. Insomnia should be assessed and if present treated with insomnia focused therapy.

Which symptom to address in psychological treatment for cancer survivors when fear of cancer recurrence, depressive symptoms, and cancer-related fatigue co-occur? Exploring the level of agreement between three systematic approaches to select the focus of treatment.

PURPOSE: To investigate the extent to which three systematic approaches for prioritizing symptoms lead to similar treatment advices in cancer survivors with co-occurring fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. METHODS: Psychological treatment advices were was based on three approaches: patient preference, symptom severity, and temporal precedence of symptoms based on ecological momentary assessments. The level of agreement was calculated according to the Kappa statistic. RESULTS: Overall, we found limited agreement between the three approaches. Pairwise comparison showed moderate agreement between patient preference and symptom severity. Most patients preferred treatment for fatigue. Treatment for fear of cancer recurrence was mostly indicated when based on symptom severity. Agreement between temporal precedence and the other approaches was slight. A clear treatment advice based on temporal precedence was possible in 57% of cases. In cases where it was possible, all symptoms were about equally likely to be indicated. CONCLUSIONS: The three approaches lead to different treatment advices. Future research should determine how the approaches are related to treatment outcome. We propose to discuss the results of each approach in a shared decision-making process to make a well-informed and personalized decision with regard to which symptom to target in psychological treatment. IMPLICATIONS FOR CANCER SURVIVORS: This study contributes to the development of systematic approaches for selecting the focus of psychological treatment in cancer survivors with co-occurring symptoms by providing and comparing three different systematic approaches for prioritizing symptoms.

Reasons for non-participation in a psychological intervention trial for distress in colorectal cancer survivors.

OBJECTIVE: High psychological distress is reported by one third of colorectal cancer survivors (CRCS). However, intervention studies for CRCS have reported low participation rates. In this study, reasons for non-participation and low uptake in a psychological intervention trial were investigated. METHODS: CRCS were recruited for a randomized clinical trial on the efficacy of blended cognitive behavior therapy for psychological distress via databases, follow-up consultations, advertisements and an ongoing population-based study. The recruitment flow and reasons for non-participation were analyzed for patients recruited between 2016 and 2020. Subgroups were compared based on demographic, clinical and screening data. High distress as study entry criterion was measured with the Distress Thermometer (DT ≥ 5) and the problem list (PL). RESULTS: From all recruitment methods together, 1326 CRCS responded to the invitation letter of whom 510 (38%) were interested in receiving a screening questionnaire. Interested CRCS were significantly younger than non-interested CRCS (p < 0.001). Most non-interested CRCS reported having no complaints. Of interested CRCS, 448 (88%) completed screening with the DT of which 213 (48%) CRCS scored above the DT cutoff for high distress. The majority expressed no need for help resulting in 84 (4% of eligible) CRCS included in the trial. Younger age, shorter time since diagnosis and more problems on the PL were positively related to participation. CONCLUSIONS: In this study a low participation rate was found. However, patients with high distress and most in need for help were included in the trial. For future research it is recommended to perform pilot- and feasibility studies to optimize recruitment.

Clinical judgment of the need for professional mental health care in patients with cancer: a qualitative study among oncologists and nurses.

PURPOSE: In daily practice, oncologists and nurses frequently need to decide whether or not to refer a patient for professional mental health care. We explored the indicators oncologists and nurses use to judge the need for professional mental health care in patients with cancer. METHODS: In a qualitative study, oncologists (n = 8) and nurses (n = 6) were each asked to select patients who were or were not referred for professional mental health care (total n = 75). During a semi-structured interview, they reflected on their decision concerning the possible referral of the patient. Thematic analysis was used to analyze the data. RESULTS: Respondents reported using a strategy when judging whether professional mental health care was needed. They allowed patients time to adjust, while monitoring patients' psychological well-being, especially if patients exhibited specific risk factors. Risk and protective factors for emotional problems included personal, social, and disease- and treatment-related factors. Respondents considered referral for professional mental health care when they noted specific indicators of emotional problems. These indicators included lingering or increasing emotions, a disproportionate intensity of emotions, and emotions with a negative impact on a patient's daily life or treatment. CONCLUSIONS: This study identified the strategy, risk and protective factors, and the indicators of emotional problems used by oncologists and nurses when judging the need for professional mental health care in patients with cancer. IMPLICATIONS FOR CANCER SURVIVORS: Oncologists and nurses can play an important role in the identification of patients in need of professional mental health care.

TIMELAPSE study-efficacy of low-dose amitriptyline versus cognitive behavioral therapy for chronic insomnia in patients with medical comorbidity: study protocol of a randomized controlled multicenter non-inferiority trial.

BACKGROUND: Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low-dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial, we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I. METHODS/DESIGN: This study will test if treatment with low-dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow-up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g., sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning), and symptoms (e.g., fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment. DISCUSSION: Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity. TRIAL REGISTRATION: Dutch Trial Register NTR NL7971 . Registered on 18 August 2019.

Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors: study protocol of a randomized controlled trial (MATCH-study).

BACKGROUND: Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients' quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. METHODS: The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients' needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). DISCUSSION: To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. TRIAL REGISTRATION: The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019.