scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

A Tablet ‐ Based Intervention for Activating Nursing Home Residents with Dementia: Results from a Cluster-Randomised Controlled Trial

2020 ◽  
Author(s):  
Julie Lorraine O'Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Nursing Homes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Cluster Randomised Controlled Trial ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background: Non-pharmacological interventions (NPI) can improve cognitive and non-cognitive symptoms in nursing home residents living with dementia. However, delivery of suitable NPI can be challenging in everyday nursing home settings. Internet and communication technologies (ICT) may be promising tools for supporting NPI delivery in nursing homes. Methods: A two-arm cluster-randomised controlled trial was conducted to investigate global and momentary effects of a novel ICT-based NPI for nursing home residents with dementia. Ten nursing homes were randomly allocated to the tablet-based intervention (TBI) or conventional activity sessions (CAS) group (each with five nursing homes) between April 2016 and May 2017. A total of N = 162 participants received either regular TBI (n = 80) or CAS (n = 82) over a period of eight weeks. Linear mixed models were used to analyse group differences regarding the primary outcome apathy (AES-I), and secondary outcomes quality of life (QOL-AD, QUALIDEM), neuropsychiatric (NPI-NH, psychotropic medication) and depressive symptoms (GDS). Ecological Momentary Assessments (EMA) of quality of life were also conducted in both groups before and after each activity session.Results: No significant group difference in the change of apathy (AES-I score, primary outcome) was found post intervention (mean group difference: B = .19; 95% CI: -3.90 to 4.28, p = .93). Regarding secondary outcomes, a reduction of psychotropic medication was found for TBI compared to CAS (B = .42; 95% CI: .15 to .69, p < .01). Further analyses revealed a post-intervention improvement of informant-rated quality of life across both groups (B = 3.69; 95% CI: .68 to 6.69, p = .02). Analysis of EMA also rendered short-term post-session improvements of quality of life in the CAS group (B = .43; 95% CI: .30 to .57, p < .001). Conclusions: These findings suggest that NPI involving individually tailored activities have a beneficial impact on quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, ICT have the potential to support NPI delivery and facilitate regular assessments of fluctuating momentary states in nursing home residents with dementia. Trial registration: The trial was retrospectively registered with the ISRCTN registry (Trial registration number: ISRCTN98947160) on 01/09/2016 http://www.isrctn.com/ISRCTN98947160.

scholarly journals Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e021531 ◽  
Author(s):  
Bethan Dalton ◽  
Savani Bartholdy ◽  
Jessica McClelland ◽  
Maria Kekic ◽  
Samantha J Rennalls ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Anorexia Nervosa ◽  
Eating Disorder ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Eating Disorder Symptoms ◽  
Randomised Controlled

ObjectiveTreatment options for severe, enduring anorexia nervosa (SE-AN) are limited. Non-invasive neuromodulation is a promising emerging intervention. Our study is a feasibility randomised controlled trial of repetitive transcranial magnetic stimulation (rTMS) in individuals with SE-AN, which aims to inform the design of a future large-scale trial.DesignDouble-blind, parallel group, two-arm, sham-controlled trial.SettingSpecialist eating disorders centre.ParticipantsCommunity-dwelling people with anorexia nervosa, an illness duration of ≥3 years and at least one previous completed treatment.InterventionsParticipants received 20 sessions (administered over 4 weeks) of MRI-guided real or sham high-frequency rTMS to the left dorsolateral prefrontal cortex in addition to treatment-as-usual.OutcomesPrimary outcomes were recruitment, attendance and retention rates. Secondary outcomes included body mass index (BMI), eating disorder symptoms, mood, quality of life and rTMS safety and tolerability. Assessments were conducted at baseline, post-treatment and follow-up (ie, at 0 month, 1 month and 4 months post-randomisation).ResultsThirty-four participants (17 per group) were randomly allocated to real or sham rTMS. One participant per group was withdrawn prior to the intervention due to safety concerns. Two participants (both receiving sham) did not complete the treatment. rTMS was safe and well tolerated. Between-group effect sizes of change scores (baseline to follow-up) were small for BMI (d=0.2, 95% CI −0.49 to 0.90) and eating disorder symptoms (d=0.1, 95% CI −0.60 to 0.79), medium for quality of life and moderate to large (d=0.61 to 1.0) for mood outcomes, all favouring rTMS over sham.ConclusionsThe treatment protocol is feasible and acceptable to participants. Outcomes provide preliminary evidence for the therapeutic potential of rTMS in SE-AN. Largest effects were observed on variables assessing mood. This study supports the need for a larger confirmatory trial to evaluate the effectiveness of multi-session rTMS in SE-AN. Future studies should include a longer follow-up period and an assessment of cost-effectiveness.Trial registration numberISRCTN14329415; Pre-results.

scholarly journals The Effect of Non-Supervised Physical Activity Before and After Breast Cancer Surgery on Quality of Life; Follow-Up Results From a Randomised Controlled Trial (Physsurg-b)

2021 ◽  
Author(s):  
Jenny Eva Maria Heiman ◽  
Aron Onerup ◽  
David Bock ◽  
Eva Haglind ◽  
Roger Olofsson Bagge
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Physical Activity ◽  
Adjuvant Chemotherapy ◽  
Controlled Trial ◽  
Breast Cancer Surgery ◽  
Before And After ◽  
Randomised Controlled

Abstract PurposeWe conducted a randomised controlled trial (PhysSURG-B) to assess the short- and long-term effects of a non-supervised physical activity intervention at the time of breast cancer surgery. Here we report a secondary outcome, quality of life (QoL).MethodsFemale patients planned for surgery were randomly assigned to either an intervention of 30 minutes of self-administered physical aerobic activity daily 2 weeks before and 4 weeks after surgery, or control. QoL was assessed with questionnaires at baseline, 4 weeks and 12 months postop using the instruments FACT-B, RAND-36 and EQ-VAS.ResultsOut of 354 included participants at 12 months follow-up after surgery, 287 were available for QoL analysis. Comparing intervention to control, the results for the FACT- B score at 4 weeks showed an odds ratio (OR) of 0.975 (95% CI 0.636-1.495) and at 12 months an OR of 0.883 (95% CI 0.581-1.342). The subgroup of patients receiving adjuvant chemotherapy had significantly lower FACT-B at 12 months compared to no chemotherapy (OR 0.475, 95% CI 0.300-0.735). EQ-VAS showed OR 1.163 (95% CI 0.760-1.779) and 0.817 (95% CI 0.536-1.244) at 4 weeks and 12 months, respectively. RAND-36 domains “role limitations due to physical health” and “pain” showed a decrease at 4 weeks in both groups, returning towards baseline at 12 months follow-up.ConclusionAn intervention of non-supervised physical activity before and after surgery for breast cancer had no effect on QoL. Patients receiving adjuvant chemotherapy had significantly lower QoL, regardless of study group.Trial registrationClinicalTrials.gov registration number: NCT 02560662. Registered 25 September, 2015.

scholarly journals Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050627
Author(s):  
Domenico Giacco ◽  
Agnes Chevalier ◽  
Megan Patterson ◽  
Thomas Hamborg ◽  
Rianna Mortimer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Social Activities ◽  
Social Contacts ◽  
Coaching Intervention ◽  
Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

scholarly journals Adherence therapy for people with schizophrenia

2006 ◽  
Vol 189 (6) ◽  
pp. 508-514 ◽  
Author(s):  
Richard Gray ◽  
Morven Leese ◽  
Jonathan Bindman ◽  
Thomas Becker ◽  
Lorenzo Burti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Education ◽  
Controlled Trial ◽  
Clinical Settings ◽  
Clinical Instability ◽  
Randomised Controlled ◽  
To Receive ◽  
Adherence Therapy

BackgroundThere is equivocal evidence of the effectiveness of adherence therapy in improving treatment adherence and clinical outcomes for people with schizophrenia.AimsTo evaluate the effectiveness of adherence therapy in improving quality of life for people with schizophrenia.MethodA 52-week, single-blind, multicentre randomised controlled trial of the effectiveness of adherence therapy. Participants were individually randomised to receive eight sessions of adherence therapy or health education. Assessments were undertaken at baseline and at 52-week follow-up.ResultsAdherence therapy was no more effective than health education in improving quality of life.ConclusionsThis effectiveness trial provides evidence for the lack of effect of adherence therapy in people with schizophrenia with recent clinical instability, treated in ordinary clinical settings.

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