Positive functioning as an outcome in its own right.
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726 to 750 of 6,178Secular trends in self reported sexual activity and satisfaction in Swedish 70 year olds: cross sectional survey of four populations, 1971-2001.
Objective: To study secular trends in self reported sexual behaviour among 70 year olds.
Design: Cross sectional survey. Settings Four samples representative of the general population in Gothenburg, Sweden.
Participants: 1506 adults (946 women, 560 men) examined in 1971-2, 1976-7, 1992-3, and 2000-1.
Main outcome measures: Sexual intercourse, attitudes to sexuality in later life, sexual dysfunctions, and marital satisfaction.
Results: From 1971 to 2000 the proportion of 70 year olds reporting sexual intercourse increased among all groups: married men from 52% to 68% (P=0.002), married women from 38% to 56% (P=0.001), unmarried men from 30% to 54% (P=0.016), and unmarried women from 0.8% to 12% (P<0.001). Men and women from later birth cohorts reported higher satisfaction with sexuality, fewer sexual dysfunctions, and more positive attitudes to sexuality in later life than those from earl…
matched on Personal Satisfaction (mesh), Quality of Life (mesh)
Johnson W, Krueger RF (2006)cohort or longitudinalMEDLINE-indexed journal, not yet read by usJournal of personality and social psychology57 citations How money buys happiness: genetic and environmental processes linking finances and life satisfaction.
Measures of wealth such as income and assets are commonly considered to be objective measures of environmental circumstances, making direct contributions to life satisfaction. Here, the authors explored the accuracy of this assumption. Using a nationwide sample of 719 twin pairs from the National Survey of Midlife Development in the United States, the authors first noted the relative independence of most perceptions about financial status from measures of actual wealth. They then demonstrated that perceived financial situation and control over life completely mediated the association between measures of actual wealth and life satisfaction. Finally, they showed that financial resources appeared to protect life satisfaction from environmental shocks. In addition, control appeared to act as a mechanism translating life circumstances into life satisfaction.
matched on Happiness (mesh), Personal Satisfaction (mesh)
Optimizing Feasibility and Acceptability of an Online Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer: A Pilot Randomized Trial of Iterative Modifications and Outcomes.
Objective: To evaluate the feasibility of an online expressive writing (EW) intervention for survivors of adolescent and young adult (AYA) cancer and determine whether iterative, theory-driven modifications can enhance response, adherence, and completion rates.
Methods: In this randomized pilot trial, survivors of AYA cancer were recruited through a hospital-based AYA oncology clinic and an online community. Forty participants were randomly assigned to the EW intervention or control group. To improve on lower-than-expected adherence and completion rates in a previous cohort, the protocol was iteratively revised using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Modifications included extending the intervention from 3 to approximately 6 weeks, allowing more flexibility; two prompt choices per session; and proactive, pers…
matched on Quality of Life (mesh), quality of life (text)
Rini C, Luta G, Ozisik D, Rowley SD, Stanton AL, Valdimarsdottir H, Austin J, Yanez B, Graves KD (2025)randomised controlled trialMEDLINE-indexed journal, not yet read by usHealth psychology : official journal of the Division of Health Psychology, American Psychological Association1 citations Effects of expressive helping writing during stem cell transplant: Randomized controlled trial.
Objective: Most cancer patients undergoing hematopoietic stem cell transplant report elevated symptoms and reduced health-related quality of life during peritransplant. These concerns can become persistent. A prior randomized controlled trial showed that expressive helping-a low-burden, brief intervention combining expressive writing with a novel peer support writing exercise-reduced psychological distress and physical symptoms in long-term transplant survivors with moderate/high persistent symptoms. The Writing for Insight, Strength, and Ease trial evaluated the use of expressive helping during peritransplant, when symptoms peak and early intervention could prevent the development of persistent symptoms.
Method: Three hundred sixty-six adult blood cancer patients (44.3% female, 74.6% White, 13.4% Black, 11.5% Hispanic/Latinx) scheduled for allogeneic (33.9%) or autologous (66.1%) transp…
matched on Quality of Life (mesh), quality of life (text)
Haberland C, Barclay M, Lehane A, Whyman S, Gater A, Wikstrom H, Seitz C, Schoof N, Schoof N, Trigg A, Bradley H (2025)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe patient2 citations Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials.
Background: Vasomotor symptoms (VMS; hot flashes) significantly impact women's health-related quality of life during the menopausal transition. Two phase III trials (OASIS 1 and 2) were conducted to investigate the efficacy and safety of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause. This exit interview study explored the impact of VMS on women's mood and work/productivity before and since treatment.
Methods: A total of 40 postmenopausal women from the USA who participated in OASIS 1 and 2 (receiving elinzanetant for 26 weeks or placebo for 12 weeks followed by elinzanetant for 14 weeks) took part in a 60-min exit interview. Interviews were conducted via telephone by trained qualitative interviewers using a semi-structured interview guide; concept-elicitation techniques, followed by focused questioning, were used to explore concepts of interest. Inter…
matched on Quality of Life (mesh), quality of life (text)
Ymer L, McKay A, Wong D, Frencham K, Grima N, Roper M, Nguyen S, Murray J, Spitz G, Ponsford J (2025)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of rehabilitation medicine6 citations Randomized controlled trial of cognitive behavioral therapy versus health education for sleep disturbance and fatigue following stroke and traumatic brain injury.
Objective: Evaluate efficacy of cognitive behavioural therapy for sleep and fatigue adapted for brain injury relative to health education control in alleviating sleep disturbance and fatigue after acquired brain injury.
Design: Parallel groups randomized controlled trial.
Subjects: 126 community dwelling adults with stroke or traumatic brain injury.
Methods: Participants were randomized 2:1 to receive 8-weeks of cognitive behavioural therapy for sleep and fatigue (n = 86) or health education (n = 40). The Pittsburgh Sleep Quality Index was assessed pre- and post-treatment, and 2 and 4-months post-treatment, with secondary measures of insomnia, fatigue, sleepiness, mood, quality of life, activity levels, self-efficacy, and actigraphy.
Results: Both groups showed improved sleep by 4-month follow-up. However, cognitive behavioural therapy for sleep and fatigue had significantly larger and m…
matched on Quality of Life (mesh), quality of life (text)
Evaluating the effects of gratitude interventions on college student well-being.
Objective: To evaluate the effects of three different gratitude interventions on college student well-being. Participants: Participants were 132 college students at a university in the northwest sampled between September 2019 and February 2020. Methods: Participants were randomly assigned to one of three gratitude interventions (journaling, reflection, app prompted reflection) or an activity-matched control group for 8 weeks and completed baseline and post-intervention assessments of well-being (e.g., satisfaction with life, happiness, resilience, depression, anxiety, and stress). Results: Participants in all three gratitude intervention groups showed improvements in well-being over time, whereas the control group did not report any such improvements. Gratitude journaling appeared to have the most significant positive impact on well-being and affective functioning. Conclusions: Gratitude…
matched on Personal Satisfaction (mesh), well-being (text)
Nakphong MK, Bright DJ, Koreitem A, Mocello AR, Lisha NE, Leslie HH, Estrada I, Libby MK, Lippman SA, Lightfoot MA (2024)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC public health7 citations Housing instability patterns among low-income, urban Black young adults in California and associations with mental health outcomes: baseline data from a randomized waitlist-controlled trial.
Background: Deep-rooted racial residential segregation and housing discrimination have given rise to housing disparities among low-income Black young adults in the US. Most studies have focused on single dimensions of housing instability, and thus provide a partial view of how Black young adults experience multiple, and perhaps overlapping, experiences of housing instability including homelessness, frequent moves, unaffordability, or evictions. We aimed to illuminate the multiple forms of housing instability that Black young adults contend with and examine relationships between housing instability and mental health outcomes.
Methods: Using baseline data from the Black Economic Equity Movement (BEEM) guaranteed income trial with 300 urban low-income Black young adults (aged 18-24), we conducted a three-stage latent class analysis using nine housing instability indicators. We identified di…
matched on Mental Health (mesh), Mental Health (keyword), well-being (text)
The co-benefits of biodiversity citizen science for well-being and nature relatedness.
Human well-being is dependent on the health of our planet. Biodiversity-related citizen science supports conservation research, and there is increasing interest in its potential as a health co-benefits intervention. This randomized controlled study investigates the health co-benefits of biodiversity citizen science participation. Seventy participants were randomly assigned to a citizen science project or control group for an 8-month period. Both groups completed pre- and post-intervention surveys, evaluating nature relatedness, self-efficacy related to biodiversity loss, subjective well-being, and climate change anxiety. A subset (N = 13) of participants engaged in the citizen science project also took part in focus group discussions. The intervention group reported a significant increase in nature relatedness and self-efficacy to help address issues of biodiversity loss. Although no sig…
matched on Personal Satisfaction (mesh), well-being (text)
Effects of remote coaching following supervised exercise oncology rehabilitation on physical activity levels, physical fitness, and patient-reported outcomes: a randomised controlled trial.
Background: Studies have shown that cancer survivors experience difficulties maintaining physical activity levels after participation in a supervised exercise rehabilitation program. This study aimed to assess the effectiveness of a six-month remote coaching intervention, following a supervised exercise oncology rehabilitation program on maintenance of PA levels; and improvement of aerobic capacity, muscle strength and patient-reported outcomes in cancer survivors.
Methods: Ninety-seven participants from a Dutch University Hospital's exercise rehabilitation program were randomised to the COACH group (n = 46), receiving 6 months of remote coaching after completing the exercise program, or the CONTROL group (n = 50), receiving no additional intervention. Assessment of PA levels; sedentary time; aerobic capacity; muscle strength; fatigue; health-related quality of life (HRQoL); level of anx…
matched on Quality of Life (mesh), quality of life (text)
Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia.
Stroke is frequently accompanied by long-term sleep disruption. We therefore aimed to assess the efficacy of digital cognitive behavioural therapy for insomnia to improve sleep after stroke. A parallel group randomised controlled trial was conducted remotely in participant's homes/online. Randomisation was online with minimisation of between-group differences in age and baseline Sleep Condition Indicator-8 score. In total, 86 community-dwelling stroke survivors consented, of whom 84 completed baseline assessments (39 female, mean 5.5 years post-stroke, mean 59 years old), and were randomised to digital cognitive behavioural therapy or control (sleep hygiene information). Follow-up was at post-intervention (mean 75 days after baseline) and 8 weeks later. The primary outcome was self-reported insomnia symptoms, as per the Sleep Condition Indicator-8 (range 0-32, lower numbers indicate more…
matched on Quality of Life (mesh), quality of life (text)
Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH (2024)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe Lancet. Digital health48 citations Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK.
Background: Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life.
Methods: In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randoml…
matched on Quality of Life (mesh), quality of life (text)
Meditation and Yoga for Irritable Bowel Syndrome: A Randomized Clinical Trial.
Introduction: Delivered in person, yoga is effective in managing irritable bowel syndrome (IBS) symptoms. The evidence for efficacy, feasibility, and safety of virtually delivered yoga for patients with IBS is unknown.
Methods: Adults diagnosed with IBS were randomized to either Hatha yoga intervention of 8 weekly online classes delivered virtually or an advice-only control group and assessed at baseline and postintervention. We used an unadjusted ANOVA to determine differences between and within groups on the primary outcome (decrease of ≥50 points in IBS Symptom Severity Scale [IBS-SSS]) and secondary outcomes (quality of life, anxiety and depression, fatigue, somatic symptoms, perceived stress, COVID-19 stress, and self-compassion). We assessed feasibility through recruitment and attrition rates, adherence, participant satisfaction, and safety (i.e., adverse events).
Results: Seventy-…
matched on Quality of Life (mesh), quality of life (text)
Garcia A, Yáñez AM, Bennasar-Veny M, Navarro C, Salva J, Ibarra O, Gomez-Juanes R, Serrano-Ripoll MJ, Oliván B, Gili M, Roca M, Riera-Serra P, Aguilar-Latorre A, Montero-Marin J, Garcia-Toro M (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usPsychiatry research17 citations Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.
Background: The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD.
Methods: This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, …
matched on Quality of Life (mesh), quality of life (text)
McGorry PD, Mei C, Amminger GP, Yuen HP, Kerr M, Spark J, Wallis N, Polari A, Baird S, Buccilli K, Dempsey SA, Ferguson N, Formica M, Krcmar M, Quinn AL, Mebrahtu Y, Ruslins A, Street R, Wannan C, Dixon L, Carter C, Loewy R, Niendam TA, Shumway M, Nelson B (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA psychiatry31 citations A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis: The Staged Treatment in Early Psychosis (STEP) Sequential Multiple Assignment Randomized Trial.
Importance: Clinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis.
Objective: To determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis.
Design, setting, and participants: The Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited.
Interventions: Step 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (C…
matched on Quality of Life (mesh), quality of life (text)
Cohen S, van Dyck CH, Gee M, Doherty T, Kanekiyo M, Dhadda S, Li D, Hersch S, Irizarry M, Kramer LD (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe journal of prevention of Alzheimer's disease71 citations Lecanemab Clarity AD: Quality-of-Life Results from a Randomized, Double-Blind Phase 3 Trial in Early Alzheimer's Disease.
Background: Lecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to amyloid-beta protein protofibrils. In phase 3 development, lecanemab has been shown to reduce markers of amyloid in early Alzheimer's disease and reduce decline on clinical endpoints of cognition and function at 18 months.
Objectives: To describe the health-related quality-of-life (HRQoL) results from Clarity AD which were exploratory outcomes in this trial.
Design: Clarity AD was an 18-month, multi-center, double-blind, phase 3 trial.
Setting: Early Alzheimer's disease.
Participants: Individuals 50-90 years of age with a diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease and positron emission tomography or cerebrospinal fluid evidence of cerebral amyloid accumulation.
Intervention: Placebo or lecanemab 10-mg/kg IV biweekly.
Measurements: HRQoL was measured at basel…
matched on Quality of Life (mesh), quality of life (text)
Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care.
Objective: To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS).
Methods: We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6-12 sessions delivered by specialised exercise- and physiotherapists.
Primary outcome measure: patient's level of functioning.
Secondary outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts.
Results: Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference - 0.50 [95% CI -1.10 to 0.10]; p = .10), and imp…
matched on Quality of Life (mesh), quality of life (text)
Mension E, Alonso I, Anglès-Acedo S, Ros C, Otero J, Villarino Á, Farré R, Saco A, Vega N, Castrejón N, Ordi J, Rakislova N, Tortajada M, Matas I, Gómez S, Ribera L, Castelo-Branco C (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA network open62 citations Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial.
Importance: Survivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce.
Objective: To assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors.
Design, setting, and participants: This prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were anal…
matched on Quality of Life (mesh), quality of life (text)
IMPACT: Evaluation of a Controlled Organizational Intervention Using Influential Peers to Promote Professional Fulfillment.
Objective: To determine the effects of a popular opinion leader (POL)-led organizational intervention targeting all physicians and advanced practice providers (APPs) working within clinic groups on professional fulfillment (primary outcome), gratitude, burnout, self-valuation, and turnover intent.
Patients and methods: All 20 Stanford University HealthCare Alliance clinics with ≥5 physicians-APPs were matched by size and baseline gratitude scores and randomly assigned to immediate or delayed intervention (control). Between July 10, 2018, and March 15, 2019, trained POLs and a physician-PhD study investigator facilitated 4 interactive breakfast or lunch workshops at intervention clinics, where colleagues were invited to discuss and experience one evidence-based practice (gratitude, mindfulness, cognitive, and behavioral strategies). Participants in both groups completed incentivized annua…
matched on Personal Satisfaction (mesh), well-being (text)
Kyle SD, Siriwardena AN, Espie CA, Yang Y, Petrou S, Ogburn E, Begum N, Maurer LF, Robinson B, Gardner C, Lee V, Armstrong S, Pattinson J, Mort S, Temple E, Harris V, Yu LM, Bower P, Aveyard P (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usLancet (London, England)59 citations Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.
Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented.
Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severi…
matched on Quality of Life (mesh), quality of life (text)
Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial.
Background: Comprehensive Geriatric Assessment (CGA)is a widely accepted intervention for frailty and can be cost-effective within a primary care setting.
Objective: To explore the feasibility of identifying older adults with frailty and assess the subsequent implementation of a tailored CGA with care and support plan by Advanced Nursing Practitioners (ANPs).
Methods: A mixed-method parallel randomised controlled trial was conducted. Participants were recruited from two General Practice (GP) centres between January and June 2019. Older adults with confirmed frailty, as assessed by practice nurses, were randomised, using a web service, to the intervention or treatment-as-usual (TAU) groups for six months with an interim and a final review. Data were collected on feasibility, health service usage, function, quality of life, loneliness, and participants' experience and perception of the int…
matched on Quality of Life (mesh), quality of life (text)
Kishimoto S, Watanabe N, Yamamoto Y, Imai T, Aida R, Germer C, Tamagawa-Mineoka R, Shimizu R, Hickman S, Nakayama Y, Etoh T, Sahker E, Carnie MB, Furukawa TA (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA dermatology24 citations Efficacy of Integrated Online Mindfulness and Self-compassion Training for Adults With Atopic Dermatitis: A Randomized Clinical Trial.
Importance: Quality of life (QOL) of patients with atopic dermatitis (AD) is reported to be the lowest among skin diseases. To our knowledge, mindfulness and self-compassion training has not been evaluated for adults with AD.
Objective: To evaluate the efficacy of mindfulness and self-compassion training in improving the QOL for adults with AD.
Design, setting, and participants: This randomized clinical trial conducted from March 2019 through October 2022 included adults with AD whose Dermatology Life Quality Index (DLQI) score, a skin disease-specific QOL measure, was greater than 6 (corresponding to moderate or greater impairment). Participants were recruited from multiple outpatient institutes in Japan and through the study's social media outlets and website.
Interventions: Participants were randomized 1:1 to receive eight 90-minute weekly group sessions of online mindfulness and self…
matched on Quality of Life (mesh), quality of life (text)
Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.
Background/hypothesis: Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems.
Study design: In an exploratory, assessor-blind randomized controlled trial, youth aged 14-25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+treatment as usual [TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary ou…
matched on Quality of Life (mesh), quality of life (text)
Khunti K, Sukumar N, Waheed G, Gillies C, Dallosso H, Brough C, Davies MJ, Fitzpatrick C, Gray LJ, Highton P, Rowlands A, Schreder S, Yates T, Saravanan P (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usDiabetic medicine : a journal of the British Diabetic Association9 citations Structured group education programme and accompanying mHealth intervention to promote physical activity in women with a history of gestational diabetes: A randomised controlled trial.
Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes.
Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self-efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups.
Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non-significant increase in physical activity at 12 months (between-group difference of 0.95 mg [95% CI: -0.46 to 2.37]), equivalent to approx…
matched on Quality of Life (mesh), quality of life (text)
Järvholm K, Janson A, Peltonen M, Neovius M, Gronowitz E, Engström M, Laurenius A, Beamish AJ, Dahlgren J, Sjögren L, Olbers T (2023)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe Lancet. Child & adolescent health45 citations Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden.
Background: Severe obesity in adolescents has a profound impact on current and future health. Metabolic and bariatric surgery (MBS) is increasingly used in adolescents internationally. However, to our knowledge, there are no randomised trials examining the currently most used surgical techniques. Our aim was to evaluate changes in BMI and secondary health and safety outcomes after MBS.
Methods: The Adolescent Morbid Obesity Surgery 2 (AMOS2) study is a randomised, open-label, multicentre trial done at three university hospitals in Sweden (located in Stockholm, Gothenburg, and Malmö). Adolescents aged 13-16 years with a BMI of at least 35 kg/m2, who had attended treatment for obesity for at least 1 year, passed assessments from a paediatric psychologist and a paediatrician, and had a Tanner pubertal stage of at least 3, were randomly assigned (1:1) to MBS or intensive non-surgical treatme…
matched on Quality of Life (mesh), quality of life (text)