Positive functioning as an outcome in its own right.
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951 to 975 of 6,178Durell TM, Adler LA, Williams DW, Deldar A, McGough JJ, Glaser PE, Rubin RL, Pigott TA, Sarkis EH, Fox BK (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of clinical psychopharmacology49 citations Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial.
Background: Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine.
Methods: Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, so…
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Hayes SC, Rye S, Disipio T, Yates P, Bashford J, Pyke C, Pyke C, Saunders C, Battistutta D, Eakin E (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usBreast cancer research and treatment141 citations Exercise for health: a randomized, controlled trial evaluating the impact of a pragmatic, translational exercise intervention on the quality of life, function and treatment-related side effects following breast cancer.
Exercise for Health was a randomized, controlled trial designed to evaluate two modes of delivering (face-to-face [FtF] and over-the-telephone [Tel]) an 8-month translational exercise intervention, commencing 6-weeks post-breast cancer surgery (PS). Outcomes included quality of life (QoL), function (fitness and upper body) and treatment-related side effects (fatigue, lymphoedema, body mass index, menopausal symptoms, anxiety, depression and pain). Generalised estimating equation modelling determined time (baseline [5 weeks PS], mid-intervention [6 months PS], post-intervention [12 months PS]), group (FtF, Tel, Usual Care [UC]) and time-by-group effects. 194 women representative of the breast cancer population were randomised to the FtF (n = 67), Tel (n = 67) and UC (n = 60) groups. There were significant (p < 0.05) interaction effects on QoL, fitness and fatigue with differences being ob…
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Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial.
Background: Fibromyalgia (FM) is characterized by widespread pain and co-morbid symptoms such as fatigue and depression. For FM, medical treatments alone appear insufficient. Recent meta-analyses point to the utility of cognitive behaviour therapy (CBT), but effects are moderate. Within the continuous development of CBT, the empirical support for acceptance and commitment therapy (ACT) has increased rapidly. ACT focuses on improving functioning by increasing the patient's ability to act in accordance with personal values also in the presence of pain and distress (i.e., psychological flexibility). However, no study has yet explored the utility of ACT in FM.
Objectives: To evaluate the efficacy of ACT for FM and the role of psychological inflexibility as a mediator of improvement.
Methods: In this randomized controlled trial, ACT was evaluated in comparison to a waiting list control condit…
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A randomized wait-list controlled pilot study of dialectical behaviour therapy guided self-help for binge eating disorder.
This study examined the efficacy of guided self-help based on dialectical behaviour therapy (DBTgsh) for binge eating disorder (BED). Individuals (88.3% female; mean 42.8 years) were randomized to DBTgsh (n=30) or wait-list (WL; n=30). DBTgsh participants received an orientation, DBT manual, and six 20-min support calls over 13 weeks. All participants were assessed pre- and post-treatment using interview and self-report; also, DBTgsh participants were re-assessed six months post-treatment. At treatment end, DBTgsh participants reported significantly fewer past-month binge eating episodes than WL participants (6.0 versus 14.4) and significantly greater rates of abstinence from binge eating (40.0% versus 3.3%). At six-month follow-up, DBTgsh participants reported significantly improved quality of life and reduced ED psychopathology compared to baseline scores. In addition, most improvement…
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Enhancing oral health via sense of coherence: a cluster-randomized trial.
Sense of coherence (SOC) has been related to oral health behaviors and oral-health-related quality of life (OHRQoL) in observational studies. This cluster-randomized trial aimed to test the effect of an intervention to enhance SOC on OHRQoL in children. Twelve primary schools were randomly allocated to intervention and control groups. The intervention was comprised of 7 sessions over 2 mos, focusing on child participation and empowerment. The first 4 sessions were classroom activities, and the last 3 involved working on healthy school projects. Trained teachers who received a one-day course delivered the intervention. Socio-demographic and clinical data, together with self-reported measures of OHRQoL, SOC, and oral health beliefs, were obtained from 261 total 10- to 12-year-olds (133 in the intervention and 128 in the control groups). Data were collected at baseline, 2 wks after the inte…
matched on Quality of Life (mesh), quality of life (text)
Clark MM, Rummans TA, Atherton PJ, Cheville AL, Johnson ME, Frost MH, Miller JJ, Sloan JA, Graszer KM, Haas JG, Hanson JM, Garces YI, Piderman KM, Lapid MI, Netzel PJ, Richardson JW, Brown PD (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usCancer91 citations Randomized controlled trial of maintaining quality of life during radiotherapy for advanced cancer.
Background: Psychosocial interventions often address only 1 domain of quality of life (QOL), are offered to patients with early-stage cancer, do not include the caregiver, and are delivered after cancer treatment has been completed.
Methods: In the current randomized controlled trial, 131 patients with advanced cancer who received radiotherapy and their caregivers were randomly assigned to either a 6-session, structured, multidisciplinary intervention arm or a standard care arm. The average age of the patients was 58 years, the majority were male (63%), and tumor types varied (gastrointestinal [37%], brain [22%], head and neck [16%], lung [13%], and other [12%]). The six 90-minute sessions addressed the 5 domains of QOL: cognitive, physical, emotional, social, and spiritual. The in-person intervention was followed by 10 brief telephone counseling sessions that took place over the next 6 …
matched on Quality of Life (mesh), quality of life (text)
Improved Strain and Psychosocial Outcomes for Caregivers of Individuals with Dementia: Findings from Project ANSWERS.
Purpose: This study examined the efficacy of a newly developed intervention, Acquiring New Skills While Enhancing Remaining Strengths (ANSWERS), for family caregivers of individuals with dementia. ANSWERS was designed for dyads comprised of an individual with dementia and his/her family caregiver. Using a strength-based approach, ANSWERS combined educational skills (traditionally used with caregivers) and cognitive rehabilitation skills training (traditionally used with individuals with dementia) into a single protocol for addressing the dyad's care issues and needs. Key domains addressed by the intervention included: education about dementia and memory loss; effective communication; managing memory; staying active; and recognizing emotions and behaviors. This analysis focused on outcomes for caregivers.
Design & methods: The Stress Process Model guided the study's hypotheses and design.…
matched on Quality of Life (mesh), well-being (text)
A patient education program is effective in reducing cancer-related fatigue: a multi-centre randomised two-group waiting-list controlled intervention trial.
Objective: To evaluate a patient education program that aims at reducing perceived fatigue in cancer survivors.
Methods: In ten German centres, 261 patients with cancer-related fatigue were randomly assigned to a patient education program consisting of 6 sessions à 90 min or standard care. The primary outcome measure was cancer-related fatigue. Data were analysed using analysis of variance (ANOVA) with repeated measures.
Results: Patients in the intervention group showed statistically significant reduction in cancer-related fatigue (F = 76.510, p < 0.001, η(2) = 0.248). Secondary outcomes also showed significant improvements in all measures, including quality of life (F = 29.607, p < 0.001, η(2) = 0.113), general self-efficacy (F = 27.680, p < 0.001, η(2) = 0.107), exercise self-efficacy (F = 49.230, p < 0.001, η(2) = 0.175), physical activity (F = 8.036, p < 0.001, η(2) = 0.033), anxiet…
matched on Quality of Life (mesh), quality of life (text)
Busse M, Quinn L, Debono K, Jones K, Collett J, Playle R, Kelly M, Simpson S, Backx K, Wasley D, Dawes H, Rosser A, Members of the COMMET-HD Management Group (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of neurologic physical therapy : JNPT75 citations A randomized feasibility study of a 12-week community-based exercise program for people with Huntington's disease.
Background and purpose: The beneficial role of exercise as a treatment approach in Huntington's disease (HD) has support from both preclinical work and small-scale studies; however, there have been no controlled studies of gym-based exercise in people with HD. This phase 2 randomized trial (ISRCTN 59910670) assessed feasibility, safety, acceptability, and benefit of a structured exercise program.
Methods: Thirty-one participants (16 men; mean [SD] age = 50.4 [11.4] years) were randomly allocated to intervention (n = 16) or control group (usual care; n = 15). The intervention entailed a weekly supervised gym session of stationary cycling and resistance exercises, and a twice weekly independent home-based walking program. Retention and adherence rates and adverse events were recorded. Acceptability was determined from subjective reports of tolerability and physiological measures recorded d…
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Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial.
Background: A recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint.
Method: This economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise ref…
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Raat H, Struijk MK, Remmers T, Vlasblom E, van Grieken A, Broeren SM, te Velde SJ, Beltman M, Boere-Boonekamp MM, L'Hoir MP (2013)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC public health19 citations Primary prevention of overweight in preschool children, the BeeBOFT study (breastfeeding, breakfast daily, outside playing, few sweet drinks, less TV viewing): design of a cluster randomized controlled trial.
Background: Two overweight prevention interventions were developed to be offered by preventive Youth Health Care (YHC) in addition to the currently applied overweight prevention protocol to parents of 0-3 year old children. The two interventions aim to support parents of preschool children to realize healthy child nutrition and activity behaviors of their young child. The aim of this study is to assess the effects of the two overweight prevention interventions with regard to child health behaviors and child Body Mass Index.
Methods/design: A cluster randomized controlled trial was conducted among parents and their preschool children who attend one of 51 participating YHC teams. The teams were randomly allocated to one of the two intervention groups, or to the control group (care as usual).The 'BBOFT+' intervention focuses on effective child rearing by parents from birth onwards by enlarg…
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Functional improvement and correlations with symptomatic improvement in adults with attention deficit hyperactivity disorder receiving long-acting methylphenidate.
Background: Data on the relationship between core symptoms and daily functioning in adults with attention deficit hyperactivity disorder (ADHD) are limited. Daily functioning was assessed as part of an open-label extension, and associations with symptom scores were evaluated.
Method: After a 5-week double-blind study with adults with ADHD receiving osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo, participants were eligible for a 7-week open-label extension in which all patients received OROS MPH. Data for the Conners' Adult ADHD Rating Scale - Observer: Screening Version (CAARS-O:SV) (primary endpoint) have been presented previously. Secondary endpoints included the observer self-reported short version of the CAARS (CAARS-S:S) and the Clinical Global Impressions - Severity Scale (CGI-S). Daily functioning and quality of life we…
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Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.
Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS.
Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The t…
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Evaluation of the effectiveness of Face IT, a computer-based psychosocial intervention for disfigurement-related distress.
Some people who have a visible difference (disfigurement) experience psychosocial adjustment problems that can lead to social anxiety and isolation. The aim of this study was to assess the effectiveness of a new computerised CBT-based intervention (Face IT) in reducing anxiety and appearance-related distress for individuals with visible differences. Face IT was tested against a non-intervention control group and standard CBT-based face-to-face delivery. Eighty-three participants were assessed at four time points using the Hospital Anxiety and Depression Scales, Derriford Appearance Scale-24, Body Image Quality of Life Inventory and Fear of Negative Evaluation (FNE). The findings indicate a significant reduction in anxiety and appearance-related distress in both the Face IT intervention and the face-to-face condition. Similar findings were reported for depressive symptoms and FNE. Results…
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The effect of oral and parenteral vitamin D supplementation in the elderly: a prospective, double-blinded, randomized, placebo-controlled study.
Hypovitaminosis D in the elderly causes falls and fractures as a result of impaired neuromuscular functions and also may be a reason for nonspecific musculosceletal pain. The aim of this study is to investigate the benefits of a single dose per os or parenterally administrated vitamin D on increasing the quality of life and functional mobility and decreasing the pain in the elderly. The community-dwelling elderly subjects over 65 years age were included in the study. The subjects were given 300.000 IU Vitamin D via per os and parenteral route and assessed after 4 weeks. The serum creatinine, calcium, phosphorous, ALT, ALP, 24-h urine calcium excretion, PTH, and vitamin D levels, as well as VAS (visual analog scale) for pain assessment, functional mobility with TUG (timed up and go test) and quality of life with SF-36 before and after the treatment were evaluated. The serum vitamin D leve…
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Ahn S, Song R (2012)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of alternative and complementary medicine (New York, N.Y.)88 citations Effects of Tai Chi Exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy.
Purpose: The aim of this study was to determine the effects of Tai Chi exercise on glucose control, neuropathy scores, balance, and quality of life in patients with type 2 diabetes and neuropathy.
Methods: A pretest-posttest design with a nonequivalent control group was utilized to recruit 59 diabetic patients with neuropathy from an outpatient clinic of a university hospital. A standardized Tai Chi for diabetes program was provided, which comprised 1 hour of Tai Chi per session, twice a week for 12 weeks. Outcome variables were fasting blood glucose and glycosylated hemoglobin for glucose control, the Semmes-Weinstein 10-g monofilament examination scores and total symptom scores for neuropathy, single leg stance for balance, and the Korean version of the SF-36v2 for quality of life. Thirty-nine patients completed the posttest measures after the 12-week Tai Chi intervention, giving a 34%…
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A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue.
The majority of people affected by Multiple Sclerosis (paMS) experience severe and disabling fatigue. A recent randomised controlled trial (RCT) showed that cognitive behaviour therapy with a clinical psychologist was an effective treatment for MS fatigue. An Internet-based version of this intervention, MS Invigor8, was developed for the current study using agile design and input from paMS. MS Invigor8 includes eight tailored, interactive sessions. The aim was to test the feasibility and potential efficacy and cost-effectiveness of the programme in a pilot RCT. 40 patients were randomised to MS Invigor8 (n=23) or standard care (n=17). The MS Invigor8 group accessed sessions over 8-10 weeks and received up to three 30-60min telephone support sessions. Participants completed online standardised questionnaires assessing fatigue, mood, quality of life and service use at baseline and 10 weeks…
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Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer.
Objective: The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group.
Methods: Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examine…
matched on Quality of Life (mesh), well-being (text)
Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD.
Methylphenidate (MPH) is widely prescribed for adults with attention deficit hyperactivity disorder (ADHD), but data on long-term treatment and maintenance of effect are lacking. Osmotic release oral system-methylphenidate (OROS-MPH) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension. Efficacy was assessed using the investigator- and subject-rated Conners' Adult ADHD Rating Scales (CAARS:O-SV and CAARS:S-S), and the Clinical Global Impression - Severity (CGI-S), Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects completing ≥52 wk of treatment were eligible for a 4-wk randomized, placebo-controlled withdrawal phase in which loss of treatment effect was assessed using CAARS:O-SV and CGI-S. In the open-label phase (n=156), mea…
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Collinson FJ, Jayne DG, Pigazzi A, Tsang C, Barrie JM, Edlin R, Garbett C, Guillou P, Holloway I, Howard H, Marshall H, McCabe C, Pavitt S, Quirke P, Rivers CS, Brown JM (2012)randomised controlled trialMEDLINE-indexed journal, not yet read by usInternational journal of colorectal disease160 citations An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer.
Purpose: There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation.
Methods/design: The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion …
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Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: a multicenter randomised controlled trial of Recapture Life-AYA.
Background: A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood.
Methods/design: This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, "ReCaPTure LiFe" will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15-25 years …
matched on Quality of Life (mesh), quality of life (text)
Quality of life of community-residing persons with dementia based on self-rated and caregiver-rated measures.
Purpose: To identify correlates of self-rated and caregiver-rated quality of life (QOL) in community-residing persons with dementia (PWD) for intervention development.
Methods: Cross-sectional data of 254 PWD and their caregivers participating in a clinical trial were derived from in-home assessments. Self-rated QOL was measured with the Quality of Life-Alzheimer Disease (QOL-AD) scale, and caregiver-rated QOL was measured using the QOL-AD and Alzheimer Disease-Related Quality of Life (ADRQL) scales. Multivariate modeling identified correlates of the PWD' QOL.
Results: Self-rated QOL was related significantly to participant race, unmet needs, depression, and total medications. Caregiver-rated QOL-AD scores were significantly associated with participant function, unmet needs, depression, and health problems and with caregiver burden and self-rated health. Significant correlates of ADRQL s…
matched on Quality of Life (mesh), quality of life (text)
Reduced risk-taking behavior as a trait feature of anxiety.
Affect can have a significant influence on decision-making processes and subsequent choice. One particularly relevant type of negative affect is anxiety, which serves to enhance responses to threatening stimuli or situations. In its exaggerated form, it can lead to psychiatric disorders, with detrimental consequences for quality of life, including the ability to make choices. This study investigated, for the first time, how pathological anxiety affects risk-taking behavior. In this study, 20 anxious participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for either generalized anxiety disorder (n = 10) and for panic attack disorder (n = 10), as well as 20 matched nonanxious controls, performed a gambling task. To investigate the tendency toward either a risk-seeking or a risk-averse behavior, we employed a task that did not allow for learning …
matched on Happiness (mesh), quality of life (text)
Longitudinal treatment mediation of traditional cognitive behavioral therapy and acceptance and commitment therapy for anxiety disorders.
Objective: To assess the relationship between session-by-session putative mediators and treatment outcomes in traditional cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) for mixed anxiety disorders.
Method: Session-by-session changes in anxiety sensitivity and cognitive defusion were assessed in 67 adult outpatients randomized to CBT (n = 35) or ACT (n = 32) for a DSM-IV anxiety disorder.
Results: Multilevel mediation analyses revealed significant changes in the proposed mediators during both treatments (p < .001, d = .90-1.93), with ACT showing borderline greater improvements than CBT in cognitive defusion (p = .05, d = .82). Anxiety sensitivity and cognitive defusion both significantly mediated post-treatment worry; cognitive defusion more strongly predicted worry reductions in CBT than in ACT. In addition, cognitive defusion significantly mediated qualit…
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Thyrian JR, Fiß T, Dreier A, Böwing G, Angelow A, Lueke S, Teipel S, Fleßa S, Grabe HJ, Freyberger HJ, Hoffmann W (2012)randomised controlled trialMEDLINE-indexed journal, not yet read by usTrials90 citations Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial.
Background: The provision of appropriate medical and nursing care for people with dementia is a major challenge for the healthcare system in Germany. New models of healthcare provision need to be developed, tested and implemented on the population level. Trials in which collaborative care for dementia in the primary care setting were studied have demonstrated its effectiveness. These studies have been conducted in different healthcare systems, however, so it is unclear whether these results extend to the specific context of the German healthcare system. The objective of this population-based intervention trial in the primary care setting is to test the efficacy and efficiency of implementing a subsidiary support system on a population level for persons with dementia who live at home.
Methods and study design: The study was designed to assemble a general physician-based epidemiological co…
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