Positive functioning as an outcome in its own right.
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1026 to 1050 of 6,178Comparing Sildenafil alone vs. Sildenafil plus brief couple sex therapy on erectile dysfunction and couples' sexual and marital quality of life: a pilot study.
Treatment options for managing erectile dysfunction (ED) include medical and psychological interventions. The present study examined the effectiveness of a drug-only vs. combined treatment approach on erectile function as well as other domains of sexual function and cognition, couple intimacy and adaptation, and treatment satisfaction. Couples with ED were randomly assigned to either Viagra-only (VO) or Viagra plus sex therapy (VST). Sexual and relationship variables were measured at specific time points. Despite limitations, study findings extend previous conclusions and provide empirical support for the effectiveness and satisfaction with the combined treatment approach for treating men with ED of mixed etiology.
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The Bipolar Interactive Psychoeducation (BIPED) study: trial design and protocol.
Background: Bipolar disorders affect between 3-5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder.
Methods/design: The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II) currently in clinical remission. The primary outcome is quality of life. This will be compared for those pat…
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Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA (2009)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA1,314 citations Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.
Context: There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer.
Objective: To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer.
Design, setting, and participants: Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont.
Interventions: A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion …
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Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS): a randomised controlled trial.
Background: Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus). Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease.
Methods: A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA) and stroke in effecting a positive change in the primary outcome measures of cardiac risk…
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Effects of a nursing intervention on quality of life outcomes in post-surgical women with gynecological cancers.
Objective: Women with gynecological cancers have reported poor health-related quality of life (QOL), with complex physical and psychological needs post-surgery and during chemotherapy treatment. There are no studies reporting interventions addressing these needs post-hospital discharge in this population.
Methods: Patients were randomized into two groups. The intervention group received 6 months of specialized care by an Advanced Practice Nurse (APN); in addition, women with high distress were evaluated and monitored by a psychiatric consultation-liaison nurse (PCLN). The attention control group was assisted with symptom management by a research assistant. The effects of the 6-month intervention were evaluated using self-report questionnaires at baseline (24-48 h after surgery), 1, 3, and 6 months post- surgery. QOL assessments included the Center for Epidemiological Studies-Depression S…
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Is serum brain-derived neurotrophic factor a biomarker for cognitive enhancement in schizophrenia?
Background: Brain-derived neurotrophic factor (BDNF) plays a critical role in neurodevelopment and plasticity; decreased BDNF functioning may contribute to the pathogenesis of schizophrenia. However, BDNF levels are not static; in animal experiments, brain BDNF increases during spatial learning, and in clinical depression, successful antidepressant treatment raises serum BDNF. We asked: would neuroplasticity-based cognitive training in schizophrenia result in increased serum BDNF?
Methods: Fifty-six schizophrenia outpatients and 16 matched healthy comparison subjects were assessed on baseline cognitive performance and serum BDNF. Schizophrenia subjects were randomly assigned to either 50 hours (10 weeks) of computerized auditory training or a computer game control condition, followed by reassessment of cognition and serum BDNF.
Results: At baseline, schizophrenia participants had signifi…
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The effect of biofeedback on function in patients with heart failure.
Decreased HRV has been consistently associated with increased cardiac mortality and morbidity in HF patients. The aim of this study is to determine if a 6-week course of heart rate variability (HRV) biofeedback and breathing retraining could increase exercise tolerance, HRV, and quality of life in patients with New York Heart Association Class I-III heart failure (HF). Participants (N = 29) were randomly assigned to either the treatment group consisting of six sessions of breathing retraining, HRV biofeedback and daily practice, or the comparison group consisting of six sessions of quasi-false alpha-theta biofeedback and daily practice. Exercise tolerance, measured by the 6-min walk test (6MWT), HRV, measured by the standard deviation of normal of normal beats (SDNN), and quality of life, measured by the Minnesota Living with Congestive Heart Failure Questionnaire, were measured baseline…
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Adamsen L, Quist M, Andersen C, Møller T, Herrstedt J, Kronborg D, Baadsgaard MT, Vistisen K, Midtgaard J, Christiansen B, Stage M, Kronborg MT, Rørth M (2009)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMJ (Clinical research ed.)304 citations Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial.
Objective: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease.
Design: Randomised controlled trial.
Setting: Two university hospitals in Copenhagen, Denmark.
Participants: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow-up.
Intervention: Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care.
Main outcome measures: European Organization fo…
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Wetherell JL, Ayers CR, Sorrell JT, Thorp SR, Nuevo R, Belding W, Gray E, Stanley MA, Areán PA, Donohue M, Unützer J, Ramsdell J, Xu R, Patterson TL (2009)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry51 citations Modular psychotherapy for anxiety in older primary care patients.
Objective: To develop and test a modular psychotherapy protocol in older primary care patients with anxiety disorders.
Design: Randomized, controlled pilot study.
Setting: University-based geriatric medicine clinics.
Participants: Thirty-one elderly primary care patients with generalized anxiety disorder or anxiety disorder not otherwise specified.
Intervention: Modular form of psychotherapy compared with enhanced community treatment.
Measurements: Self-reported, interviewer-rated, and qualitative assessments of anxiety, worry, depression, and mental health-related quality of life.
Results: Both groups showed substantial improvements in anxiety symptoms, worry, depressive symptoms, and mental health-related quality of life. Most individuals in the enhanced community treatment condition reported receiving medications or some other form of professional treatment for anxiety. Across both co…
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Evaluating a brief prevention program for improving marital conflict in community families.
Marital conflict is related to well-being in children and adults (E. M. Cummings & P. T. Davies, 2002). Marital conflict is likely most effectively ameliorated before it becomes clinically significant. However, families without significant problems may be unwilling to participate in couples therapies or other lengthy or intensive interventions. Responding to this gap, the authors developed a 4-session psychoeducational program about marital conflict for community families. Couples with children 4-8 years of age were randomly blocked into 1 of 3 groups: (1) a parent-only group (n = 24), (2) a parent-child group (n = 33), or (3) a self-study group (n = 33). Pre- and posttest and 6-month and 1-year assessments were conducted. This report evaluates (a) whether participation in a psychoeducational program for parents improved marital conflict, especially concerning ways of expressing disagree…
matched on Personal Satisfaction (mesh), well-being (text)
Efficacy of an insomnia intervention on fatigue, mood and quality of life in breast cancer survivors.
Aim: This paper is a report of a study to describe the efficacy of cognitive behavioural therapy for insomnia on fatigue, mood and quality of life in breast cancer survivors.
Background: Women who receive primary treatment for breast cancer often complain of insomnia. Rarely evaluated in insomnia intervention studies is the effect of cognitive behavioural treatment on the psychosocial outcomes of fatigue, mood and quality of life.
Method: Data were collected between December 2002 and March 2004 with 72 women who were at least 3 months post-completion of primary treatment without current evidence of disease. Women were randomly assigned to either the cognitive behavioural therapy for insomnia group, which received stimulus control instructions, sleep restriction therapy and sleep education and hygiene, or the component control group which received sleep education and hygiene only. The 10-…
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Dhall G, Grodman H, Ji L, Sands S, Gardner S, Dunkel IJ, McCowage GB, Diez B, Allen JC, Gopalan A, Cornelius AS, Termuhlen A, Abromowitch M, Sposto R, Finlay JL (2008)randomised controlled trialMEDLINE-indexed journal, not yet read by usPediatric blood & cancer155 citations Outcome of children less than three years old at diagnosis with non-metastatic medulloblastoma treated with chemotherapy on the "Head Start" I and II protocols.
Purpose: To determine the survival of infants and young children with non-metastatic medulloblastoma using intensive myeloablative chemotherapy and autologous hematopoietic progenitor cell rescue (AuHCR).
Methods: Twenty-one children less than 3 years old at diagnosis with non-metastatic medulloblastoma were enrolled on two identical serial studies, "Head Start" I and "Head Start" II. After surgery, patients received five cycles of induction chemotherapy consisting of vincristine, cisplatin, cyclophosphamide and etoposide. Following induction, all patients underwent myeloablative chemotherapy using carboplatin, thiotepa and etoposide with AuHCR. Irradiation was used only at relapse.
Results: The 5-year event-free (EFS) and overall survival (OS) rates (+/-SE) for all patients, patients with gross total resection, and patients with residual tumor were 52 +/- 11% and 70 +/- 10%, 64 +/- 13% …
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Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial.
Objective: The purpose of this study was to evaluate the quality of life (QOL) after laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG) in patients with early gastric cancer.
Summary background data: LADG has been beneficial in terms of pain, recovery, and morbidity when compared with open surgery with equal oncologic outcome. There has been no clinical study on QOL.
Methods: From July 2003 to November 2005, 164 patients with newly diagnosed cT1N0M0 and cT1N1M0 distal gastric cancer were randomly assigned either to LADG or ODG. All patients were asked to complete the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 questionnaires preoperatively and postoperatively on regular follow-up visits.
Results: Statistically significant differences were observed with a more favorable outcome noted in the LADG group with respec…
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Correspondence between EQ-5D health state classifications and EQ VAS scores.
Background: The EQ-5D health-related quality of life instrument comprises a health state classification followed by a health evaluation using a visual analogue scale (VAS). The EQ-5D has been employed frequently in economic evaluations, yet the relationship between the two parts of the instrument remains ill-understood. In this paper, we examine the correspondence between VAS scores and health state classifications for a large sample, and identify variables which contribute to determining the VAS scores independently of the health states as classified.
Methods: A UK trial of management of low-grade abnormalities detected on screening for cervical pre-cancer (TOMBOLA) provided EQ-5D data for over 3,000 women. Information on distress and multi-dimensional health locus of control had been collected using other instruments. A linear regression model was fitted, with VAS score as the dependen…
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Welton AJ, Vickers MR, Kim J, Ford D, Lawton BA, MacLennan AH, Meredith SK, Martin J, Meade TW, WISDOM team (2008)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMJ (Clinical research ed.)115 citations Health related quality of life after combined hormone replacement therapy: randomised controlled trial.
Objective: To assess the effect of combined hormone replacement therapy (HRT) on health related quality of life.
Design: Randomised placebo controlled double blind trial.
Setting: General practices in United Kingdom (384), Australia (94), and New Zealand (24).
Participants: Postmenopausal women aged 50-69 at randomisation; 3721 women with a uterus were randomised to combined oestrogen and progestogen (n=1862) or placebo (n=1859). Data on health related quality of life at one year were available from 1043 and 1087 women, respectively.
Interventions: Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year.
Main outcome measures: Health related quality of life and psychological wellbeing as measured by the women's health questionnaire. Changes in emotional and physical menopausal symptoms as measured by a symptoms questio…
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Exercise on prescription for women aged 40-74 recruited through primary care: two year randomised controlled trial.
Objective: To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period.
Design: Randomised controlled trial.
Setting: 17 primary care practices in Wellington, New Zealand
Participants: 1089 women aged 40-74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week
Intervention: Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months.
Main outcome measure: Physical activity assessed at baseline and 12 and 24 months. Secondary outcomes were quality of life (SF-36), weight, waist circumference, blood pressure, concentrations of fasting serum lipids, glycated haemoglobin (HbA(1c)), glucose, insulin, and physical fitness.
Results: Mean age was 58.9 (SD 7) years. Trial retention rates were 93% and…
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Daytime functioning in older patients suffering from chronic insomnia: treatment outcome in a randomized controlled trial comparing CBT with Zopiclone.
The paper presents data from a randomized controlled trial comparing treatment effects of cognitive behavioural therapy (CBT), hypnotic treatment (Zopiclone), and placebo in a sample of insomnia patients. Data from the same trial have already demonstrated that CBT was more efficient in improving sleep than Zopiclone. The novel outcomes that are reported here concern daytime functioning. Forty-six older patients (age >or= 55) qualifying for a diagnosis of primary insomnia were recruited to participate. Assessments were completed at baseline, post-treatment, and at a 6-months follow-up, and measures of worry, anxiety, depression, interpersonal relationships, subjective alertness, vigilance, and quality of life were used. The participants in both treatment conditions scored within the normal range on the outcome measures at baseline with the exception of reporting less alertness, relative t…
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A randomised trial of a 5 week, manual based, self-management programme for hypertension delivered in a cardiac patient club in Shanghai.
Background: In Shanghai there are 1.2 million people with hypertension, many of whom have difficulty in affording medical treatment. Community based, anti-hypertensive clubs have been created to provide health education but education alone is often ineffective. Lifestyle change programmes have shown some potential for reducing blood pressure but in previous trials have required specialist staff and extensive contact. We have previously demonstrated that self-management programmes delivered by health professionals, such as a nurse who has had short training in self-management techniques can change health behaviour and reduce symptoms. This study was designed to evaluate the benefits of a simple, cognitive-behavioural, self-management programme for hypertension based around a hypertension manual and delivered in the setting of a community anti-hypertensive club in Shanghai.
Method: The met…
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Acceptance and Commitment Therapy and yoga for drug-refractory epilepsy: a randomized controlled trial.
Objective: There is a need for controlled outcome studies on behavioral treatment of epilepsy. The purpose of this study was to evaluate Acceptance and Commitment Therapy (ACT) and yoga in the treatment of epilepsy.
Methods: The design consisted of a randomized controlled trial with repeated measures (N=18). All participants had an EEG-verified epilepsy diagnosis with drug-refractory seizures. Participants were randomized into one of two groups: ACT or yoga. Therapeutic effects were measured using seizure index (frequency x duration) and quality of life (Satisfaction with Life Scale, WHOQOL-BREF). The treatment protocols consisted of 12 hours of professional therapy distributed in two individual sessions, two group sessions during a 5-week period, and booster sessions at 6 and 12 months posttreatment. Seizure index was continuously assessed during the 3-month baseline and 12-month follow…
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Is internet-based CBT for panic disorder and agoraphobia as effective as face-to-face CBT?
This study compared Panic Online (PO), an internet-based CBT intervention, to best-practice face-to-face CBT for people with panic disorder with or without agoraphobia. Eighty-six people with a primary diagnosis of panic disorder were recruited from Victoria, Australia. Participants were randomly assigned to either PO (n=46) or best practice face-to-face CBT (n=40). Effects of the internet-based CBT program were found to be comparable to those of face-to-face CBT. Both interventions produced significant reductions in panic disorder and agoraphobia clinician severity ratings, self reported panic disorder severity and panic attack frequency, measures of depression, anxiety, stress and panic related cognitions, and displayed improvements in quality of life. Participants rated both treatment conditions as equally credible and satisfying. Participants in the face-to-face CBT treatment group c…
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Double-blind, randomized comparison of memantine and escitalopram for the treatment of major depressive disorder comorbid with alcohol dependence.
Objective: The aim of the study was to evaluate possible new treatments for major depressive disorder in patients with comorbid alcohol dependence in a municipal alcohol treatment unit. The efficacy of memantine, a noncompetitive glutamate N-methyl-D-aspartate (NMDA)-receptor blocker used for the treatment of moderate to severe Alzheimer's disease, was compared with that of escitalopram, a selective serotonin reuptake inhibitor antidepressant.
Method: Eighty alcohol-dependent outpatients with major depressive disorder (DSM-IV criteria) seeking treatment from municipal alcohol treatment clinics in Helsinki, Finland, were randomly assigned 1:1 to receive memantine 20 mg/day or escitalopram 20 mg/day. During the study period, patients continued their routine treatment at the clinics. Abstinence was not required. Concomitant interventions or imposed treatment goals were not offered by the st…
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Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial.
Objectives: To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer, with six month follow-up.
Design: Pragmatic randomised controlled prospective open trial.
Setting: Three National Health Service oncology clinics in Scotland and community exercise facilities.
Participants: 203 women entered the study; 177 completed the six month follow-up.
Interventions: Supervised 12 week group exercise programme in addition to usual care, compared with usual care.
Main outcome measures: Functional assessment of cancer therapy (FACT) questionnaire, Beck depression inventory, positive and negative affect scale, body mass index, seven day recall of physical activity, 12 minute walk test, and assessment of shoulder mobility.
Results: Mixed effects models with adjustment for baseline values, study site, treatment at…
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Combined brief psychosexual intervention after mastectomy: effects on sexuality, body image, and psychological well-being.
Background: Mastectomy poses a severe threat to body image and sexuality, interfering with the psychological well-being of both the patient and her partner. Although many psychotherapeutic approaches have been assessed and found effective in such patients, few studies have assessed couple or sex therapy in mastectomy patients.
Methods: We report on a structured combination of brief couples and sex therapy (CBPI) used in 20 women with in situ breast cancer and mastectomy and their partners. An equal number of mastectomy patients were used as controls.
Results: CBPI patients showed significant improvement in depression and state anxiety scores, as well as in body image, satisfaction with relationship, presumed attractiveness to their partner, orgasm frequency and communicating their desire.
Discussion/conclusions: CBPI can be used as an effective alternative to individual or group psychoth…
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Northouse LL, Mood DW, Schafenacker A, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Kershaw T (2007)randomised controlled trialMEDLINE-indexed journal, not yet read by usCancer254 citations Randomized clinical trial of a family intervention for prostate cancer patients and their spouses.
Background: Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses.
Methods: For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 co…
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The effect of walking and vitamin B supplementation on quality of life in community-dwelling adults with mild cognitive impairment: a randomized, controlled trial.
Objectives: To examine the effect of walking and vitamin B supplementation on quality-of-life (QoL) in community-dwelling adults with mild cognitive impairment.
Methods: One year, double-blind, placebo-controlled trial. Participants were randomized to: (1) twice-weekly, group-based, moderate-intensity walking program (n = 77) or a light-intensity placebo activity program (n = 75); and (2) daily vitamin B pills containing 5 mg folic acid, 0.4 mg B12, 50 mg B6 (n = 78) or placebo pills (n = 74). QoL was measured at baseline, after six and 12 months using the population-specific Dementia Quality-of-Life (D-QoL) to assess overall QoL and the generic Short-Form 12 mental and physical component scales (SF12-MCS and SF12-PCS) to assess health-related QoL.
Results: Baseline levels of QoL were relatively high. Modified intention-to-treat analyses revealed no positive main intervention effect of w…
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