Positive functioning as an outcome in its own right.
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1051 to 1075 of 6,178Cognitive remediation therapy (CRT) for young early onset patients with schizophrenia: an exploratory randomized controlled trial.
Background: Schizophrenia with an onset in adolescence is known to be associated with a poorer outcome and cognitive difficulties. These impairments have an impact on quality of life and represent treatment targets. Cognitive remediation therapy (CRT) attempts to improve cognitive deficits by teaching information processing strategies through guided mental exercises. The objective of this study is to evaluate the efficacy of CRT in alleviating cognitive deficits compared to treatment as usual and explore the mediating and moderating effects of cognitive improvement.
Method: Single-blind randomized controlled trial with two groups, one receiving CRT (N21) and the other standard care (N19) assessed at baseline, 3 months (post therapy) and follow-up (3 months post therapy). Participants were recruited from specialist inpatient and community mental health services and were young patients wit…
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Do supervised weekly exercise programs maintain functional exercise capacity and quality of life, twelve months after pulmonary rehabilitation in COPD?
Background: Pulmonary rehabilitation programs have been shown to increase functional exercise capacity and quality of life in COPD patients. However, following the completion of pulmonary rehabilitation the benefits begin to decline unless the program is of longer duration or ongoing maintenance exercise is followed. Therefore, the aim of this study is to determine if supervised, weekly, hospital-based exercise compared to home exercise will maintain the benefits gained from an eight-week pulmonary rehabilitation program in COPD subjects to twelve months.
Methods: Following completion of an eight-week pulmonary rehabilitation program, COPD subjects will be recruited and randomised (using concealed allocation in numbered envelopes) into either the maintenance exercise group (supervised, weekly, hospital-based exercise) or the control group (unsupervised home exercise) and followed for twe…
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Group-based intervention program in inflammatory bowel disease patients: effects on quality of life.
Background: Inflammatory bowel diseases (IBD) such as ulcerative colitis (UC) and Crohn's disease (CD) have great impact on patients' health-related quality of life (HRQOL). The aim of this study was to develop an integrated medical and psychological/ psychosocial group-based intervention program for IBD patients and to evaluate if such a program could influence the patients' HRQOL and coping abilities.
Methods: IBD patients in remission or with low disease activity were randomized to intervention or control groups. The intervention comprised nine weekly sessions, alternating lectures, and group therapy sessions. The Inflammatory Bowel Disease Questionnaire (IBDQ) and the Sense of Coherence scale (SOC) were used to measure HRQOL and coping ability at 0, 6, and 12 months. The intervention was evaluated by a visual analog scale (VAS) and written comments by a content analysis.
Results: In …
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Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial.
Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail. Results were analyzed on an intention-to-treat basis, including all randomized participants. From pre- to posttest, treated participants in contrast to controls showed significant improvement on most measured dimensions (social anxiety scales, general anxiety and depression levels, quality of life). The overall within- and between-groups effect sizes were Cohen's d = 0.87 and 0.70, respectively. Treatment gains were maintained at 1-year follow-up. The results from this study support the continued use and development of Internet-distributed, self-…
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Rummans TA, Clark MM, Sloan JA, Frost MH, Bostwick JM, Atherton PJ, Johnson ME, Gamble G, Richardson J, Brown P, Martensen J, Miller J, Piderman K, Huschka M, Girardi J, Hanson J (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology244 citations Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial.
Purpose: The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer.
Patients and methods: Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4…
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The effect of Johrei healing on substance abuse recovery: a pilot study.
Objective: The purpose of the present study was to determine the effectiveness of Johrei healing, a form of energy healing, on substance use and psychologic symptoms in a sample of clients receiving substance abuse treatment.
Methods: Twenty-one (21) persons in residential substance-abuse treatment participated in a randomized, wait-list control pilot study of Johrei healing. Twelve (12) of the participants received three 20-minute Johrei sessions for 5 weeks in addition to their regular treatment.
Results: The results are from the first treatment wave. Individual healing sessions were evaluated pre-post with the Johrei Experience Scale. Participants showed significant decreases in stress/depression and physical pain and increases in positive emotional/spiritual state, energy, and overall well-being after an individual Johrei healing session. The Global Assessment of Individual Need (GAI…
matched on Quality of Life (mesh), well-being (text)
Outpatient psychotherapy for borderline personality disorder: randomized trial of schema-focused therapy vs transference-focused psychotherapy.
Context: Borderline personality disorder is a severe and chronic psychiatric condition, prevalent throughout health care settings. Only limited effects of current treatments have been documented.
Objective: To compare the effectiveness of schema-focused therapy (SFT) and psychodynamically based transference-focused psychotherapy (TFP) in patients with borderline personality disorder.
Design: A multicenter, randomized, 2-group design.
Setting: Four general community mental health centers.
Participants: Eighty-eight patients with a Borderline Personality Disorder Severity Index, fourth version, score greater than a predetermined cutoff score.
Intervention: Three years of either SFT or TFP with sessions twice a week.
Main outcome measures: Borderline Personality Disorder Severity Index, fourth version, score; quality of life; general psychopathologic dysfunction; and measures of SFT/TFP per…
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Land SR, Wickerham DL, Costantino JP, Ritter MW, Vogel VG, Lee M, Pajon ER, Wade JL, Dakhil S, Lockhart JB, Wolmark N, Ganz PA (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA165 citations Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.
Context: Tamoxifen has been approved for breast cancer risk reduction in high-risk women, but how raloxifene compares with tamoxifen is unknown.
Objective: To compare the differences in patient-reported outcomes, quality of life [QOL], and symptoms in Study of Tamoxifen and Raloxifene (STAR) participants by treatment assignment.
Design, setting, participants, and interventions: STAR was a double-blind, randomized phase 3 prevention trial designed to evaluate the relative efficacy of raloxifene vs tamoxifen in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. Between July 1, 1999, and November 4, 2004, 19,747 participants were enrolled at centers throughout North America, with a median potential follow-up time of 4.6 years (range, 1.2-6.5 years). Patient-reported symptoms were collected from all participants using a 36-item symptom checklist. Quality of l…
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Low-dose sertraline in the treatment of moderate-to-severe premenstrual syndrome: efficacy of 3 dosing strategies.
Objective: Many studies have demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of premenstrual dysphoric disorder, but few studies have investigated the efficacy of SSRIs in the treatment of premenstrual syndrome (PMS). The objective of this study was to evaluate the safety and efficacy of sertraline in the treatment of moderate-to-severe PMS using 3 different dosing strategies: luteal phase (2 cycles), followed by continuous dosing throughout the month (1 cycle), followed by dosing begun at the first onset of PMS symptoms, or "symptom-onset" dosing (1 cycle).
Method: 314 women with PMS from 22 U.S. sites were randomly assigned to fixed-dose treatment with sertraline (25 or 50 mg/day) or placebo for 4 menstrual cycles after a single-blind, placebo lead-in cycle. Assessments included the Daily Symptom Report (DSR), the Clinical Global Impression…
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Adler LA, Sutton VK, Moore RJ, Dietrich AP, Reimherr FW, Sangal RB, Saylor KE, Secnik K, Kelsey DK, Allen AJ (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of clinical psychopharmacology37 citations Quality of life assessment in adult patients with attention-deficit/hyperactivity disorder treated with atomoxetine.
Background: Attention-deficit/hyperactivity disorder (ADHD) has its onset during childhood and is estimated to affect 3% to 7% of school-aged children. Unfortunately, the disorder frequently persists into adult life. The burden of this disorder is considerable and is often characterized by academic (or occupational) impairment and dysfunction within the family and society. Despite the existence of research demonstrating the effects of ADHD on certain aspects of life, the clinical trials of treatments for this disorder have focused primarily on efficacy and safety.
Methods: Atomoxetine was approved in the United States in November 2002 for the treatment of ADHD in children, adolescents, and adults. The present study uses data from a clinical trial of atomoxetine in adult patients with ADHD that incorporated a measure of health-related quality of life (the Medical Outcomes Study 36-item sh…
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Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S, Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usAnnals of internal medicine476 citations Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial.
Background: Caring for a family member with dementia is extremely stressful, contributes to psychiatric and physical illness among caregivers, and increases the risk for caregiver death. Finding better ways to support family caregivers is a major public health challenge.
Objective: To test the effects of a structured multicomponent intervention on quality of life and clinical depression in caregivers and on rates of institutional placement of care recipients in 3 diverse racial or ethnic groups.
Design: Randomized, controlled trial.
Setting: In-home caregivers in 5 U.S. cities.
Participants: 212 Hispanic or Latino, 219 white or Caucasian, and 211 black or African-American caregivers and their care recipients with Alzheimer disease or related disorders.
Intervention: Caregivers within each racial or ethnic group were randomly assigned to an intervention or to a control group. The interven…
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Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology156 citations A tailored smoking, alcohol, and depression intervention for head and neck cancer patients.
Background: Smoking, alcohol use, and depression are interrelated and highly prevalent in patients with head and neck cancer, adversely affecting quality of life and survival. Smoking, alcohol, and depression share common treatments, such as cognitive behavioral therapy and antidepressants. Consequently, we developed and tested a tailored smoking, alcohol, and depression intervention for patients with head and neck cancer.
Methods: Patients with head and neck cancer with at least one of these disorders were recruited from the University of Michigan and three Veterans Affairs medical centers. Subjects were randomized to usual care or nurse-administered intervention consisting of cognitive behavioral therapy and medications. Data collected included smoking, alcohol use, and depressive symptoms at baseline and at 6 months.
Results: The mean age was 57 years. Most participants were male (84%…
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O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology414 citations Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer.
Purpose: For patients with small-cell lung cancer (SCLC), further chemotherapy is routinely considered at relapse after first-line therapy. However, proof of clinical benefit has not been documented.
Patients and methods: This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care (BSC) alone (n = 70) or oral topotecan (2.3 mg/m2/d, days 1 through 5, every 21 days) plus BSC (topotecan; n = 71).
Results: In the intent-to-treat population, survival (primary end point) was prolonged in the topotecan group (log-rank P = .0104). Median survival with BSC was 13.9 weeks (95% CI, 11.1 to 18.6) and with topotecan, 25.9 weeks (95% CI, 18.3 to 31.6). Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval (< or = 60 days). Response to topotecan was 7% partia…
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Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls.
Objective: This study evaluated a 10-week Internet-based bibliotherapy self-help program with short weekly telephone calls for people suffering from panic disorder with or without agoraphobia.
Method: After the authors confirmed the diagnosis by administering the Structured Clinical Interview for DSM-IV by telephone, 60 participants were randomly assigned to either a wait-listed control group or a multimodal treatment package based on cognitive behavior therapy plus minimal therapist contact via e-mail. A 10-minute telephone call was made each week to support each participant. Total mean time spent on each participant during the 10 weeks was 3.9 hours. The participants were required to send in homework assignments before receiving the next treatment module.
Results: Analyses were conducted on an intention-to-treat basis, which included all randomly assigned participants. From pretreatmen…
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Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa--a pilot study.
Purpose: Psychological interventions in the treatment of epilepsy have been developed and evaluated for many years but the amount of research has hardly made an impact on how epilepsy is treated. The purpose of this study was to develop and evaluate a psychological treatment program consisting of acceptance and commitment therapy (ACT) together with some behavioral seizure control technology shown to be successful in earlier research.
Methods: The method consisted of a randomized controlled trial group design with repeated measures (n=27). All participants had an EEG verified epilepsy diagnosis with drug refractory seizures. Participants were randomized into one of two conditions, ACT or supportive therapy (ST). Therapeutic effects were measured by examining changes in quality of life (SWLS and WHOQOL) and seizure index (frequency x duration). Both treatment conditions consisted of only …
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A randomized clinical trial of group-based cognitive-behavioral stress management in localized prostate cancer: development of stress management skills improves quality of life and benefit finding.
Background: Recent literature has indicated that a significant percentage of oncology patients describe finding some benefit (e.g., improved personal growth, sense of meaning, and enhanced interpersonal relationships) in the cancer experience. However, few studies have investigated the role of group-based psychosocial interventions in improving benefit finding (BF), and virtually none have investigated these constructs in men.
Purpose: This study examined whether a cognitive-behavioral stress management (CBSM) intervention improves BF and quality of life (QoL) in men recovering from treatment for localized prostate cancer.
Methods: Participants in this study were 191 men (M age = 65.1) treated with radiation or radical prostatectomy for clinically localized (i.e., Stage I or II) prostate cancer. Participants were primarily non-Hispanic White (40%) or Hispanic (41%), followed by Black (18…
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Specialised care for early psychosis: symptoms, social functioning and patient satisfaction: randomised controlled trial.
Background: The provision of early intervention services for people with psychosis is UK government policy, although evidence for benefit of such services is sparse.
Aims: To evaluate the effects of a service providing specialised care for early psychosis (the Lambeth Early Onset Team) on clinical and social outcomes, and on service user satisfaction.
Method: One hundred and forty-four people with psychosis, presenting to mental health services for the first or second time (if previously failed to engage in treatment), were randomly allocated to care by the early onset team or to standard care. Information was obtained on symptoms, treatment adherence, social and vocational functioning, satisfaction and quality of life. Relapse and rehospitalisation data have been reported separately.
Results: Outcomes for the participants treated by the early onset team were significantly better at 18 m…
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Trivedi MH, Rush AJ, Wisniewski SR, Warden D, McKinney W, Downing M, Berman SR, Farabaugh A, Luther JF, Nierenberg AA, Callan JA, Sackeim HA (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe Journal of clinical psychiatry121 citations Factors associated with health-related quality of life among outpatients with major depressive disorder: a STAR*D report.
Objective: Major depressive disorder (MDD) is often chronic and is often associated with significant morbidity and mortality. The importance of assessing disability and health-related quality of life (HRQOL) in patients with MDD has only recently been recognized. The aim of this study was to examine sociodemographic and clinical correlates of HRQOL in a large cohort of outpatients with MDD.
Method: Baseline assessments were completed for 1500 consecutive patients enrolled in the Sequenced Treatment Alternatives to Relieve Depression trial, including sociodemographic characteristics and measures of depressive symptom severity, clinical features, and HRQOL. Multiple domains of HRQOL were assessed with the 12-item Short Form Health Survey, the Work and Social Adjustment Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire. The current analyses were conducted on HRQOL data…
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Martinez FJ, Foster G, Curtis JL, Criner G, Weinmann G, Fishman A, DeCamp MM, Benditt J, Sciurba F, Make B, Mohsenifar Z, Diaz P, Hoffman E, Wise R, NETT Research Group (2006)randomised controlled trialMEDLINE-indexed journal, not yet read by usAmerican journal of respiratory and critical care medicine314 citations Predictors of mortality in patients with emphysema and severe airflow obstruction.
Purpose: Limited data exist describing risk factors for mortality in patients having predominantly emphysema.
Subjects and methods: A total of 609 patients with severe emphysema (ages 40-83 yr; 64.2% male) randomized to the medical therapy arm of the National Emphysema Treatment Trial formed the study group. Cox proportional hazards regression analysis was used to investigate risk factors for all-cause mortality. Risk factors examined included demographics, body mass index, physiologic data, quality of life, dyspnea, oxygen utilization, hemoglobin, smoking history, quantitative emphysema markers on computed tomography, and a modification of a recently described multifunctional index (modified BODE).
Results: Overall, high mortality was seen in this cohort (12.7 deaths per 100 person-years; 292 total deaths). In multivariate analyses, increasing age (p=0.001), oxygen utilization (p=0.04),…
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A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170].
Background: Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care.
Methods: We performed a 12-month randomized controlled trial. From November 2001 to April 2003, we enrolled participants aged 30-80, who had heart failure and took furosemide. Intervention patients received education on self-care emphasizing daily weight measurement, diuretic dose self-adjustment, and symptom recognition and response. Picture-based educational materials, a digital scale, and scheduled telephone follow-up were provided to reinforce adherence. Control patients received a generic heart failure brochure and usual care. Primary outcomes were combined hospital…
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Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial.
Background: Family caregivers for cancer patients experience high levels of stress and burden and diminished quality of life (QOL). Interventions to improve coping skills of caregivers have been shown to be effective with other populations, but their impact has not been assessed in the difficult context of hospice care. The purpose of this study was to determine whether hospice plus a coping skill training intervention improved family caregivers' QOL, burden, coping, and mastery, compared with hospice plus emotional support, and usual hospice care.
Methods: A three group randomized controlled trial was conducted including baseline, 16 day, and 30 day assessments conducted from March 1999 to May 2003. The sample consisted of 354 family caregivers of community dwelling hospice patients with advanced cancer. Patient/caregiver dyads were randomly divided into three groups, including a contro…
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Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects.
Purpose: Chronic insomnia is highly prevalent in cancer patients. Cognitive-behavioral therapy (CBT) is considered the treatment of choice for chronic primary insomnia. However, no randomized controlled study has been conducted on its efficacy for insomnia secondary to cancer. Using a randomized controlled design, this study conducted among breast cancer survivors evaluated the effect of CBT on sleep, assessed both subjectively and objectively, and on hypnotic medication use, psychological distress, and quality of life.
Patients and methods: Fifty-seven women with insomnia caused or aggravated by breast cancer were randomly assigned to CBT (n = 27) or a waiting-list control condition (n = 30). The treatment consisted of eight weekly sessions administered in a group and combined the use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue management. Follo…
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Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E (2005)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology475 citations Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study.
Purpose: To evaluate the effect on survival and quality of life of maintaining hemoglobin (Hb) in the range of 12 to 14 g/dL with epoetin alfa versus placebo in women with metastatic breast cancer (MBC) receiving first-line chemotherapy.
Patients and methods: Eligible patients were randomly assigned to receive epoetin alfa 40,000 U once weekly or placebo for 12 months. Study drug was initiated if baseline Hb was < or = 13 g/dL or when Hb decreased to < or = 13g/dL during the study. The primary end point was 12-month overall survival (OS).
Results: The study drug administration was stopped early in accordance with a recommendation from the Independent Data Monitoring Committee because of higher mortality in the group treated with epoetin alfa. Enrollment had been completed, with 939 patients enrolled (epoetin alfa, n = 469; placebo, n = 470). Most patients had Hb more than 12 g/dL at base…
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Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients.
Background: Quality of life (QoL) is now established as an important outcome for evaluating the impact of disease, and for assessing the efficacy of treatments. However, individuals change with time and the basis on which they make a QoL judgement may also change, a phenomenon increasingly referred to as response shift. Here, the individual may change his or her internal standards, values, and/or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status. This has important implications for assessing the effects of treatments as a change in QoL may reflect a response shift, a treatment effect, or a complex combination of both. In this study, we used an individualised quality of life (IQoL) measure, the SEIQoL, together with a then-test to determine whether response shift would influence the measurement of treatment efficacy …
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Dance and movement program improves quality-of-life measures in breast cancer survivors.
A pilot research study was conducted at 2 cancer centers in Connecticut to determine the effect of a dance and movement program on quality of life and shoulder function in breast cancer survivors treated within the prior 5 years. Thirty-five women completed the trial that included a 12-week intervention, using The Lebed Method, Focus on Healing Through Movement and Dance. The study design was a randomized control trial with a wait list control group crossover to active treatment in weeks 13 to 25, with the treatment group receiving the program in weeks 1 to 12, and no program in weeks 13 to 25. Outcome measures were the Breast Cancer Quality of Life (FACT-B), Shoulder range of motion (ROM), and Body Image Scale. FACT-B significantly improved in the intervention group at 13 weeks from 102.0 +/- 15.8 to 116.7 +/- 16.9, compared to the wait list group 108.1 +/- 16.4 to 107.1 +/- 21.3 (time …
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