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Study question How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression?Methods This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme (“Beating the Blues”) or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months.Study answer and limitations Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. What this study adds Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care.Funding, competing interests, data sharing Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management groupTrial registration Current Controlled Trials ISRCTN91947481.

Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems—10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00–1·47; risk difference=12·1%, 95% CI 1·6%–22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02–2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74–1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. The Wellcome Trust.

Background This study investigated the effectiveness of brief midwife-led counseling based on Gamble and colleagues’ approach in decreasing post-traumatic stress disorder, depression, and anxiety symptoms among a group of women who had experienced a traumatic childbirth. Methods From among 270 pregnant women screened to participate in the study, 90 women experienced a traumatic childbirth. They were randomly assigned into two groups: intervention ( n  = 45) and control group ( n  = 45). We did a face-to-face counseling session within 72 h after giving birth and a telephone counseling session four to 6 weeks after giving birth for the intervention group. The control group only received the postnatal routine care. The outcome measures were post-traumatic stress disorder, depression, and anxiety symptoms. Results At the three-month follow-up, the intervention group showed significantly higher improvement on post-traumatic stress disorder, depression, and anxiety symptoms compared to the control group. Conclusions Gamble and colleagues’ midwife-led brief counseling could be an effective approach to reduce psychological distress of women who have experienced a traumatic childbirth. Trial registration number IRCT201608285417N2 , Date of Registration: 2/21/2017.

This paper reports the final 24-month outcomes of a randomized controlled trial evaluating the effect of additional therapeutic contact (ATC) as an adjunct to a community-based weight-management program for overweight and obese 13–16-year-olds. ATC involved telephone coaching or short-message-service and/or email communication once per fortnight. Adolescents were randomized to receive the Loozit group program—a two-phase behavioral lifestyle intervention with ( n =73), or without ( n =78), ATC in Phase 2. Adolescents/parents separately attended seven weekly group sessions (Phase 1), followed by quarterly adolescent sessions (Phase 2). Assessor-blinded, 24-month changes in anthropometry and metabolic health included primary outcomes body mass index (BMI) z -score and waist:height ratio (WHtR). Secondary outcomes were self-reported psychosocial and lifestyle changes. By 24 months, 17 adolescents had formally withdrawn. Relative to the Loozit program alone, ATC largely had no impact on outcomes. Secondary pre-post assessment of the Loozit group program showed mean (95% CI) reductions in BMI z -score (−0.13 (−0.20, −0.06)) and WHtR (−0.02 (−0.03, −0.01)) in both arms, with several metabolic and psychosocial improvements. Adjunctive ATC did not provide further benefits to the Loozit group program. We recommend that further work is needed to optimize technological support for adolescents in weight-loss maintenance. Australian New Zealand Clinical Trials Registry Number ACTRNO12606000175572.

Introduction: Substantial evidence indicates that cigarette smoking among people living with HIV/AIDS (PLWHA) represents a significant public health concern. However, few efforts to assess smoking cessation interventions targeting this population have been reported. In this brief report, 3-month outcomes from an ongoing treatment trial for PLWHA who smoke are described. Methods: Study participants were recruited from a large HIV care center serving a diverse population of PLWHA. A two-group randomized design was used to compare the efficacy of usual-care (UC) smoking cessation treatment versus a cell phone intervention (CPI). Follow-ups were conducted at the HIV clinic 3 months postenrollment. Using an intent-to-treat approach, a series of multiple regression models were used to compare smoking outcomes in the 2 groups. Results: Four hundred and seventy-four participants were enrolled and randomized, UC (n = 238) and CPI (n = 236). Mean age in the sample was 44.8 (SD = 8.1) years, and the majority were male (70.0%), Black (76.6%), and had an education level of high school or less (77.5%). At follow-up, participants in the CPI group were 4.3 (95% CI = 1.9, 9.8) times more likely to be abstinent (7 day) compared with those in the UC group. Similarly, significant point estimates were observed for the other smoking outcomes of interest. Conclusions: Findings from this preliminary report indicate that a smoking cessation intervention for PLWHA consisting of cell phone-delivered proactive counseling results in significantly higher abstinence rates compared with a standard care approach. Evaluation of the long-term (6-month and 12-month) efficacy of the CPI approach is ongoing.

Malnutrition is associated with mortality and impaired quality of life (QoL) in systemic immunoglobulin light-chain (AL) amyloidosis. The aim of this study was to determine whether nutritional counseling is beneficial to patients with AL. In this intervention study (ClinicalTrials.gov Identifier: NCT02055534), 144 treatment-naïve outpatients with AL were randomized to usual care (UC; n = 72) and nutritional counseling (NC; n = 72). In the randomized population, although patients in the NC group maintained a stable body weight (weight loss [WL] = 0.6 kg; 95% confidence interval [CI], −1.0 to 2.1; P = 0.214), those in the UC group demonstrated a significant decrease (WL = 2.1 kg; 95% CI, 0.2–4.1; P = 0.003). However, the difference in weight between groups was not significant (mean WL difference = 1.6 kg; 95% CI, −0.7 to 3.9; P = 0.179). Patients in the NC group demonstrated more satisfactory energy intake (≥75% of estimated requirements, odds ratio, 2.18; 95% CI, 1.04–4.57; P = 0.048) and a significant increase in the mental component summary of QoL (Short form-36) at 12 mo (mean difference, 8.1; 95% CI, 2.3–13.9; P = 0.007), which was restored to a mean score of 53 (95% CI, 50–53), over the healthy population norms. NC was also associated with better survival (crude hazard ratio, 0.57; 95% CI, 0.35–0.94; P = 0.028). In outpatients with AL, NC was helpful in preserving body weight, effective in improving mental QoL, and associated with better survival. •We investigated whether nutritional counseling is beneficial to patients with systemic immunoglobulin light-chain amyloidosis.•Nutritional counseling was helpful in preserving body weight in these patients.•Nutritional counseling was effective in improving the mental quality of life of these patients.•Nutritional counseling was associated with better survival in patients with systemic immunoglobulin light-chain amyloidosis.

Background Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR). Methods A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5–52. Secondary outcomes were: CAR from weeks 5–10 and 5–22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures. Results The CARs for weeks 5–52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04–3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5–22 (OR, 2.01; CI, 1.20–3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04–2.85) and VR (OR, 1.96; CI, 1.20–3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5–10 (OR, 1.52; CI, 1.00–2.30 and OR, 1.58; CI, 1.04–2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03–2.41 and OR, 1.79; CI, 1.17–2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups. Conclusions Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy. Trial registration ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011

Background Information and discussion of sexual changes with a health professional is a high priority for many cancer patients in order to assist with sexual changes and ensure that sexual intimacy does not cease post-cancer. The PLISSIT model is widely recommended as a framework for providing sexual information and support, allowing for the discussion of sexual changes at various levels of increasing intensity. The aim of the present study is to evaluate the early stages of the PLISSIT model by examining the relative efficacy of written information provision about cancer related sexual changes, and information provision accompanied by a single session of counselling, for people with cancer and their partners, across a range of cancer types. Method Eighty-eight people with cancer and 53 partners across a range of sexual and non-sexual cancers, took part in a randomised trial which adopted mixed method analysis to examine changes in psychological wellbeing, quality of life, relationship satisfaction and communication, and sexual functioning, following written information provision about cancer related sexual changes (self-help condition; SH), or written information accompanied by a single session of counselling (health professional condition; HP). Results Ratings of the usefulness and efficacy of the SH and HP interventions, collected through analysis of Likert scales, open ended survey items and interviews, indicated that both conditions were found to be useful and efficacious by the majority of participants, serving to increase awareness of sexuality, improve couple communication about sex, and help in the management of sexual changes, through the exploration of non-coital sexual practices. In contrast, the quantitative analysis of standardized instruments found no significant improvements in psychological wellbeing, quality of life, relationship satisfaction and communication, or sexual functioning. There were significant reductions in self-silencing in the HP condition, and a trend towards increases in sexual satisfaction across both conditions. Conclusion These results offer support for the early stages of the PLISSIT model, in terms of normalization and increased awareness of sexual changes after cancer, increased couple communication about sexual changes, and legitimation of exploration of a range of non-coital sexual practices and intimacy. However, more complex and intensive interventions are needed to address sexual functioning and psychological wellbeing. The findings provide support for the proposition that providing permission to discuss sexuality should be the core feature underpinning all stages of interventions designed to provide sexuality information and support for people with cancer and their partners, and also demonstrate the potential importance of limited information and specific suggestions. Trial registration This study was registered in the Australian New Zealand Clinical Trials Registry. ( ACTRN12615000399594 ) on 29 April 2015.

Background Several intervention studies have demonstrated that exercise training has beneficial effects among cancer patients. However, older cancer patients are underrepresented in clinical trials, and only few exercise-based studies have focused specifically on older patients with cancer. In particular, research investigating the effects of exercise training among older patients with advanced cancer is lacking. The purpose of the current study is to investigate the effect of a 12-week multimodal and exercise-based intervention among older patients (≥65 years) with advanced pancreatic, biliary tract or lung cancer, who are treated with first-line palliative chemotherapy, immunotherapy or targeted therapy. Methods PACE-Mobil-PBL is a two-armed randomized controlled trial. Participants will be randomized 1:1 to an intervention group ( N  = 50) or a control group ( N  = 50). Participants in the intervention group will receive standard oncological treatment and a 12-week multimodal intervention, comprised of: (I) supervised exercise training, twice weekly in the hospital setting, (II) home-based walking with step counts and goal-setting, (III) supportive and motivational nurse-led counseling, and (IV) protein supplement after each supervised training session. Participants in the control group will receive standard oncological treatment. The primary outcome is physical function measured by the 30-s chair stand test. Secondary outcomes include measures of feasibility, activity level, physical capacity and strength, symptom burden, quality of life, toxicity to treatment, dose reductions, inflammatory biomarkers, body weight and composition, hospitalizations and survival. Assessments will be conducted at baseline, and after 6, 12 and 16 weeks. Discussion The current study is one of the first to investigate the effect of an exercise-based intervention specifically targeting older patients with advanced cancer. PACE-Mobil-PBL supports the development of health promoting guidelines for older patients with cancer, and the study results will provide new and valuable knowledge in this understudied field. Trial registration The study was prospectively registered at ClinicalTrials.gov on January 26, 2018 (ID: NCT03411200 ).

Background Intimate partner violence (IPV) against women is a global health problem that is a substantial source of human suffering. Within the United States (US), women veterans are at high risk for experiencing IPV. There is an urgent need for feasible, acceptable, and patient-centered IPV counseling interventions for the growing number of women treated in the US’s largest integrated healthcare system, the Veterans Health Administration (VHA). Implementation science and user-centered-design (UCD) can play an important role in accelerating the research-to-practice pipeline. Recovering from IPV through Strengths and Empowerment (RISE) is a flexible, patient-centered, modular-based program that holds promise as a brief counseling intervention for women veterans treated in VHA. We utilized a UCD approach to develop and refine RISE (prior to formal effectiveness evaluations) by soliciting early feedback from the providers where the intervention will ultimately be implemented. The current study reports on the feedback from VHA providers that was used to tailor and refine RISE. Method We conducted and analyzed semi-structured, key-informant interviews with VHA providers working in clinics relevant to the delivery of IPV interventions ( n  = 23) at two large medical centers in the US. Participants’ mean age was 42.6 years (SD = 11.6), they were predominately female (91.3%) and from a variety of relevant disciplines (39.1% psychologists, 21.7% social workers, 17.4% physicians, 8.7% registered nurses, 4.3% psychiatrists, 4.3% licensed marriage and family therapists, 4.3% peer specialists). We conducted rapid content analysis using a hybrid inductive-deductive approach. Results Providers perceived RISE as highly acceptable and feasible, noting strengths including RISE’s structure, patient-centered agenda, and facilitation of provider comfort in addressing IPV. Researchers identified themes related to content and context modifications, including requests for additional safety check-ins, structure for goal-setting, and suggestions for how to develop and implement RISE-specific trainings. Conclusions These findings have guided refinements to RISE prior to formal effectiveness testing in VHA. We discuss implications for the use of UCD in intervention development and refinement for interventions addressing IPV and other trauma in health care settings globally. Trial registration ClinicalTrials.gov identifier: NCT03261700; Date of registration: 8/25/2017, date of enrollment of first participant in trial: 10/22/2018. Unique Protocol ID: IIR 16–062.