Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community.

BACKGROUND: Fear of falling (FoF) is a lasting concern about falling that leads to an individual avoiding activities that he/she remains capable of performing. It is a common condition amongst older adults and may occur independently of previous falls. Cognitive behavioural therapy (CBT), a talking therapy that helps change dysfunctional thoughts and behaviour, with and without exercise, may reduce FoF, for example, by reducing catastrophic thoughts related to falls, and modifying dysfunctional behaviour. OBJECTIVES: To assess the benefits and harms of CBT for reducing FoF in older people living in the community, and to assess the effects of interventions where CBT is used in combination with exercise. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1, 2023), MEDLINE Ovid (from 1946 to 11 January 2023), Embase Ovid (from 1980 to 11 January 2023), CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature) (from 1982 to 11 January 2023), PsycINFO (from 1967 to 11 January 2023), and AMED (Allied and Complementary Medicine from 1985 to 11 January 2023). We handsearched reference lists and consulted experts for identifying additional studies. SELECTION CRITERIA: This review included randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs assessing CBT with and without exercise interventions compared to control groups with sham-treatment, or treatment as usual. We defined CBT as a collaborative, time-limited, goal-oriented, and structured form of speaking therapy. Included studies recruited community-dwelling older adults, with a mean population age of at least 60 years minus one standard deviation, and not defined by a specific medical condition. DATA COLLECTION AND ANALYSIS: Two review authors used standard methodological procedures expected by Cochrane. For continuous data, as assessed by single- or multiple-item questionnaires, we report the mean difference (MD) with 95% confidence interval (CI) when studies used the same outcome measures, and standardised mean difference (SMD) when studies used different measures for the same clinical outcome. For dichotomous outcomes, we reported the treatment effects as risk ratios (RR) with 95% CIs. We measured the primary outcome, FoF, immediately, up to, and more than six months after the intervention. We analysed secondary outcomes of activity avoidance, occurrence of falls, depression, and quality of life when measured immediately after the intervention. We assessed risk of bias for each included study, using the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We selected 12 studies for this review, with 11 studies included for quantitative synthesis. One study could not be included due to missing information. Of the 11 individual studies, two studies provided two comparisons, which resulted in 13 comparisons. Eight studies were RCTs, and four studies were cluster-RCTs. Two studies had multiple arms (CBT only and CBT with exercise) that fulfilled the inclusion criteria. The primary aim of 10 studies was to reduce FoF. The 11 included studies for quantitative synthesis involved 2357 participants, with mean ages between 73 and 83 years. Study total sample sizes varied from 42 to 540 participants. Of the 13 comparisons, three investigated CBT-only interventions while 10 investigated CBT with exercise. Intervention duration varied between six and 156 hours, at a frequency between three times a week and monthly over an eight- to 48-week period. Most interventions were delivered in groups of between five and 10 participants, and, in one study, up to 25 participants. Included studies had considerable heterogeneity, used different questionnaires, and had high risks of bias. CBT interventions with and without exercise probably improve FoF immediately after the intervention (SMD -0.23, 95% CI -0.36 to -0.11; 11 studies, 2357 participants; moderate-certainty evidence). The sensitivity analyses did not change the intervention effect significantly. Effects of CBT with or without exercise on FoF may be sustained up to six months after the intervention (SMD -0.24, 95% CI -0.41 to -0.07; 8 studies, 1784 participants; very low-certainty evidence). CBT with or without exercise interventions for FoF probably sustains improvements beyond six months (SMD -0.28, 95% CI -0.40 to -0.15; 5 studies, 1185 participants; moderate-certainty of evidence). CBT interventions for reducing FoF may reduce activity avoidance (MD -2.57, 95% CI -4.67 to -0.47; 1 study, 312 participants; low-certainty evidence), and level of depression (SMD -0.41, 95% CI -0.60 to -0.21; 2 studies, 404 participants; low-certainty evidence). We are uncertain whether CBT interventions reduce the occurrence of falls (RR 0.96, 95% CI 0.66 to 1.39; 5 studies, 1119 participants; very low-certainty evidence). All studies had a serious risk of bias, due to performance bias, and at least an unclear risk of detection bias, as participants and assessors could not be blinded due to the nature of the intervention. Downgrading of certainty of evidence also occurred due to heterogeneity between studies, and imprecision, owing to limited sample size of some studies. There was no reporting bias suspected for any article. No studies reported adverse effects due to their interventions. AUTHORS' CONCLUSIONS: CBT with and without exercise interventions probably reduces FoF in older people living in the community immediately after the intervention (moderate-certainty evidence). The improvements may be sustained during the period up to six months after intervention (low-certainty evidence), and probably are sustained beyond six months (moderate-certainty evidence). Further studies are needed to improve the certainty of evidence for sustainability of FoF effects up to six months. Of the secondary outcomes, we are uncertain whether CBT interventions for FoF reduce the occurrence of falls (very low-certainty evidence). However, CBT interventions for reducing FoF may reduce the level of activity avoidance, and may reduce depression (low-certainty evidence). No studies reported adverse effects. Future studies could investigate different populations (e.g. nursing home residents or people with comorbidities), intervention characteristics (e.g. duration), or comparisons (e.g. CBT versus exercise), investigate adverse effects of the interventions, and add outcomes (e.g. gait analysis). Future systematic reviews could search specifically for secondary outcomes.

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial.

PURPOSE: Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS. METHODS: A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a "slight improvement." RESULTS: Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS. CONCLUSION: TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least "slight pain relief" from PBT. Differences for gender and incident pain aspects demand future trials.

Severe symptoms and very low quality-of-life among outpatients newly diagnosed with advanced cancer: data from a multicenter cohort study.

PURPOSE: The aim of this study was to identify symptoms of severe intensity or very low scores for quality of life (QoL) domains in newly diagnosed outpatients with advanced cancer. METHODS: This multicenter cohort study from a state-wide palliative care network included adult outpatients with advanced cancer diagnosed within the preceding 8 weeks from four comprehensive cancer centers (DRKS00006162, registered on 19 May 2014). We used the Palliative Outcome Scale (POS), Hospital Anxiety and Depression Scale, and European Organization for Research and Treatment of Cancer QoL Questionnaire-C30. For each questionnaire, cut-off scores defined symptoms and QoL domains that were considered "severe" or "very low." RESULTS: Of 3155 patients screened, 481/592 (81.3%) were analyzed (mean age 62.4; women n = 245, 50.9%). We identified 324/481 (67.4%) patients experiencing at least one severe symptom or a very low QoL domain (median 2; range 0 to 16). Role functioning (n = 180, 37.4%), fatigue (n = 162, 33.7%), and social functioning (n = 126, 26.2%) were most commonly affected. QoL was very low in 89 patients (18.5%). Women experienced more anxiety symptoms, fatigue, and had lower POS scores. Patients often mentioned physical symptoms and fears of adverse events resulting from disease-modifying therapies (e.g., chemotherapy) as most relevant problems. CONCLUSIONS: Already within the first 8 weeks after diagnosis, the majority of patients reported at least one severe symptom or a very low QoL domain. Gender differences were evident. The findings illustrate the value of early routine assessment of patient burden and the development of multi-professional and interdisciplinary palliative care.