scholarly journals Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e046477
Author(s):  
Cintia Tur ◽  
Daniel Campos ◽  
Rocio Herrero ◽  
Sonia Mor ◽  
Alba López-Montoyo ◽  
...  

IntroductionGrief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive–behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT—called GROw—for PGD. As a secondary objective, the potential effectiveness of GROw will be explored.Methods and analysisThis study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8–10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion).Ethics and disseminationThe Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences.Trial registration numberNCT04462146.

2020 ◽  
Vol 24 (56) ◽  
pp. 1-44
Author(s):  
Judith Stephenson ◽  
Julia V Bailey ◽  
Ann Blandford ◽  
Nataliya Brima ◽  
Andrew Copas ◽  
...  

Background Effective use of contraception can reduce numbers of unintended pregnancies, but misunderstandings and concerns about contraception abound. Increasingly, women seek health-care information online. Objectives To develop an interactive website to aid informed choice of contraceptive method, including long-acting reversible contraception (Phase I), and test its effectiveness in a parallel, single-blind randomised trial (Phase II). Approval came from London – Camden & King’s Cross Research Ethics Committee (reference 17/LO/0112). Setting and participants For both phases, women aged 15–30 years were recruited from general practice, sexual health services, maternity services, community pharmacies and an abortion service. Design In Phase I, we conducted three systematic literature reviews, a review of YouTube (YouTube, LLC, San Bruno, CA, USA) videos about contraception, and focus groups and interviews with young women to explore barriers to and concerns and misperceptions about contraception. We then iteratively co-designed an interactive website, Contraception Choices [URL: www.contraceptionchoices.org (accessed June 2020)], with young women and a software company. In Phase II, we evaluated the website through a randomised trial that began as a feasibility trial. Early demand for Contraception Choices stimulated a design change from a feasibility to an efficacy trial, with follow-up for clinical outcomes at 3 and 6 months. A randomisation list was incorporated into the trial software program to allocate participants to the intervention (website) or control group (standard care). Intervention Contraception Choices is a co-designed, evidence-based, interactive website to aid informed choice of contraception. It provides information about different methods, addresses common concerns and offers tailored contraceptive options in response to individual preferences. Main outcome measures Qualitative – participant views and experience of the intervention, assessed through qualitative interviews. Quantitative primary outcomes – follow-up rate at 6 months in the initial feasibility trial, using a long-acting reversible contraception method, and satisfaction with contraceptive method at 6 months in the efficacy trial. Results A total of 927 women were randomised online to the website (n = 464) or control group (n = 463), of whom 739 (80%) provided follow-up data at 6 months [786 women (85%) provided data at 3 and/or 6 months that were included in the analysis of primary outcomes]. There was little difference between groups in the proportion using long-acting reversible contraception at 6 months [30.4% intervention vs. 31.0% control, adjusted odds ratio after imputation 0.87 (95% confidence interval 0.60 to 1.27)] or in satisfaction with contraceptive method [proportion being ‘satisfied’ or ‘very satisfied’, 82.6% intervention vs. 82.1% control, adjusted odds ratio 0.93 (95% confidence interval 0.69 to 1.25)]. Qualitative evaluation indicated highly positive views about the website and increased knowledge of contraceptive methods that could dispel misperceptions. Women appreciated having information tailored to their specific needs and felt better prepared before consultations. Limitations We did not include intermediate measures, such as knowledge of contraceptive methods, intention to change method or confidence in discussing contraception with a health-care professional, which may have indicated other benefits of using the website. In future, the website should be studied in different settings (e.g. schools and in routine practice) to see whether or not it improves the quality or efficiency of contraceptive consultations. Conclusions Our systematic review indicated wide-ranging influences on women’s use of contraception globally. The website, Contraception Choices, was very popular with young women and contraception service providers. It was not associated with statistically significant differences in use of long-acting reversible contraception or satisfaction with contraceptive method at 6 months. Trial registration Current Controlled Trials ISRCTN13247829. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 56. See the NIHR Journals Library website for further project information.


2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
M Perez Serrano ◽  
CNP Carlos Nicolas Perez Garcia ◽  
DEV Daniel Enriquez Vazquez ◽  
MFE Marcos Ferrandez Escarabajal ◽  
JDD Jesus Diz Diaz ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction patients with heart failure (HF) are especially vulnerable to SAR-CoV-2 infection especially due to their worse prognosis for this disease. Purpose to demonstrate that patients with HF will present similar health outcomes if their education and pharmacological treatment is optimised remotely by a nurse rather than through conventional care. Methods  A single-centre, observational, prospective, non-randomized study was carried out in which two groups were compared. The experimental group had most of their care provided virtually by a nurse who could optimise their medication according to the clinical guides whilst the control group received conventional face-to-face care. During a follow-up period of 6 months, patients included in the study have an initial face-to-face consultation with a cardiologist and an evaluation of the patient where the treatment objectives are established. The rest of the follow-ups were done through videoconsultation with the nurse every 15 days for 6 months where the neurohormonal treatment was optimized and an educational program was carried out with different cardiovascular educational topics. Results   Thirty-seven patients have been included. Sex: 30 men (81.0%) and 7 women (19.0%) Mean age: 67.9 years (12.8). Range 42-87 years. Etiology: 61.2% ischemic and 38.8% non-ischemic mean LVEF at inclusion = 30.2%. A total of 17 patients have completed the study: a 13% average improvement of FEVI, a reduction of NT-proBNP of and improvement in functional heart failure class. The primary objective was to compare the proportion of neurohormonal drugs prescribed, as well as the mean of the maximum doses reached in each after 6 months of follow-up, as well as mean ejection fraction, NYHA class and mean NT-proBNP (Table 1) Conclusions Telemedicine offers us valuable tools that allow us to take care of chronic patients, reducing exposure to the virus as much as possible. Efficient use of virtual tools and human resources makes close monitoring possible. Specialized nursing is a key element in the education, pharmacological optimization and monitoring of these patients. Parámetros analíticos Valores iniciales Valores finales NT-proBNP ( pg/mL) 3469,7 (± 4057,3) 1446,4 (± 1305,2) Creatinina (mg/dL) 1,10 (± 0,24) 1,12 (± 0,39) TFG (mL/min/1,73m2 ) 65,4 (± 21,2) 62,7 (± 23, 6) Potasio (meq /L) 4,5 (± 0,5) 4,6 (± 0,4) Fevi 29,4 % (± 7,2) FEVI 42,7 % (± 9,6)


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
K. Sorsdahl ◽  
D. J. Stein ◽  
S. Pasche ◽  
Y. Jacobs ◽  
R. Kader ◽  
...  

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)


2021 ◽  
Author(s):  
Rajesh Kumar ◽  
Ravi Kant ◽  
Poonam Yadav ◽  
Tamar Rodney ◽  
Mukesh Bairwa

Abstract BackgroundThe burden of tobacco-associated disorders is prevalent worldwide. Over the years, many innovative internet-based approaches have been utilized with variable success to quit tobacco. Though the effectiveness of internet-based and face-to-face interventions on quitting smoking are very well reported in the literature, due to limitation in methodology and limited sample size, it is required to integrate and analyze these studies' findings to reach a single conclusion. The study evaluated the effectiveness of the internet as an intervention approach versus face-to-face interaction on reducing tobacco use as control among adults.MethodsA systematic search was performed through various electronic databases such as Medline, PsychInfo, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), ResearchGate, Google Scholar, and Academia. Reference lists of the eligible articles were also screened. Full-text articles were included as per eligibility criteria (PICO framework). No ethnicity restriction was applied.ResultsA total of 13 studies were selected for meta-analysis, with 3852 and 3908 participants in intervention and control groups respectively. Forest plot favours the intervention group at one month follow up for tobacco quitting (OR: 2.37, CI: 1.86-3.02, P-0.00001, I2 =0%), at three months (OR: 1.88, CI: 1.48-2.40, P-0.00001, I2 =42%) at six months (OR: 2.02, CI: 1.64-2.50, P-0.00001, I2 =38%) and at 1 year of follow-up (OR: 1.43, CI: 1.18-1.74, P-0.00001, I2 = 36%) comparing to control group. ConclusionInternet and web-based interventions are highly useful in tobacco quitting at one month, three months, six months, and one year of follow-up compared to face-to-face interaction or no intervention, although the level of evidence was moderate. Additionally, limited availability of trials in developing countries, arising need for research of internet use in developing countries to quit tobacco. Prospero Registration number- PROSPERO 2020 CRD42020214306


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Salazar ◽  
V Vilchez-Barboza ◽  
K Saez ◽  
T Paravic

Abstract Objective To establish the effect after 24 months of a face-to-face and telephone nursing counseling intervention, aimed at controlling cardiovascular risk factors (hypertension, dyslipidemia and overweight) and improving health-related quality of life (HRQoL) in patients of the cardiovascular health program of family health centers of Concepciόn, Chile. Methods Randomized controlled clinical trial with a 24 months post-intervention follow-up. 120 patients with cardiovascular risk factors under the cardiovascular health program were recruited from 6 family health centers and randomized into a control group (60) and an intervention group (60). The intervention group received the regular care in addition to face-to-face and telephone nursing counseling. Baseline measurements were taken and also at the end of the intervention (7 months). Participants returned then after 12 and 24 months for follow-up evaluations. A total of 109 subjects completed the intervention at 7 months and 45 returned at 24 months. During follow-up evaluations both groups continued to receive regular care given in the health centers. The measurements consisted of HRQoL (physical and mental health), systolic blood pressure (SBP) and diastolic blood pressure (DBP), body mass index (BMI), abdominal circumference (AC), total cholesterol (TC), low density lipoproteins (LDL-Chol), high density lipoprotein (HDL-Chol), atherogenicity index (LDL/HDL), cardiovascular risk factor (TC/HDL), 10-year coronary risk. Ethical requirements were considered and statistical analysis was carried out using MANCOVA and d-Cohen repeated measurements. Results The analysis of the effects of the intervention in the 24-month follow-up showed that subjects in the intervention group only maintained significant improvement of AC over time (F=3.18; p=0.03), compared to the control group. Conclusion Although participants in the intervention group only maintained the AC improvement over time, this can be regarded as an indirect indicator of the presence of intra-abdominal fat that makes it possible to predict and classify the risk of cardiovascular disease. Long-term follow-up studies are required to investigate behaviors and mechanisms that contribute to maintaining improvements in this indicator. Additionally, future research should include reinforcement activities, either face-to-face or by telephone, to help maintain the positive results of interventions. Acknowledgement/Funding Universidad de Concepciόn 214.082.049-1.0


Gut ◽  
2020 ◽  
pp. gutjnl-2020-322026
Author(s):  
Vincent Huberty ◽  
Ivo Boskoski ◽  
Vincenzo Bove ◽  
Pauline Van Ouytsel ◽  
Guido Costamagna ◽  
...  

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.


Psymedica ◽  
2010 ◽  
Vol 1 (1-2) ◽  
Author(s):  
Milan Stojaković ◽  
S. Medenlica ◽  
Bogdan Stojakovic

GOALS: The authors' objective is to analyze Quality of Life (QoL) and depression in the Enduring personality change after catastrophic expirience (F62.0)SUBJECTS AND METHODS: In study we include 120 adult men, 60 subjects with diagnosis F62.0. according to ICD-10 (experimental group) and 60 adult men veterans without the diagnosis of F62.0 (control group). The subjects were assessed with the standardized psychometric instruments.RESULTS: In subjects with Enduring personality change (F62.0) assessment of QoL shows differences in some segments that are important for further monitoring and analysis. The results of the depression in experimental and control group show statistically significance on level (p< 0.05) for baseline visit and follow-up visit.CONCLUSIONS: The statistical relationship between level of combat exposure and war-related F62.0. depression symptoms and QoL, suggests that it may take time for the consequences of traumatic exposure to become apparent. Moreover, degree of exposure may be important in predicting the eventual development of symptoms and precipitation of F62.0. Continued follow-up will address the evolution of PTSD symptoms in war related PTSD. The results indicate the importance of further monitoring and analysis symptoms of depression in F62.0 and QoL.


2017 ◽  
Vol 21 (4) ◽  
pp. 1-62 ◽  
Author(s):  
Paul Little ◽  
Beth Stuart ◽  
FD Richard Hobbs ◽  
Jo Kelly ◽  
Emily R Smith ◽  
...  

BackgroundBehavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed.ObjectivesTo estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice.DesignIndividually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews.SettingPrimary care general practices in the UK.ParticipantsPatients with a body mass index of ≥ 30 kg/m2(or ≥ 28 kg/m2with risk factors) identified from general practice records, recruited by postal invitation.InterventionsPositive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls).Main outcome measuresThe primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months.ResultsA total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81%; control,n = 227; POWeR+F,n = 221; POWeR+R,n = 218). The control group maintained nearly 3 kg of weight loss per person (mean weight per person: baseline, 104.4 kg; 6 months, 101.9 kg; 12 months, 101.7 kg). Compared with the control group, the estimated additional weight reduction with POWeR+F was 1.5 kg [95% confidence interval (CI) 0.6 to 2.4 kg;p = 0.001] and with POWeR+R was 1.3 kg (95% CI 0.34 to 2.2 kg;p = 0.007). By 12 months the mean weight loss was not statistically significantly different between groups, but 20.8% of control participants, 29.2% of POWeR+F participants (risk ratio 1.56, 95% CI 0.96 to 2.51;p = 0.070) and 32.4% of POWeR+R participants (risk ratio 1.82, 95% CI 1.31 to 2.74;p = 0.004) maintained a clinically significant 5% weight reduction. The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [control, 47.1% (64/136); POWeR+F, 37.2% (51/137); POWeR+R, 26.7% (40/150)]. The incremental cost to the health service per kilogram weight lost, compared with the control group, was £18 (95% CI –£129 to £195) for POWeR+F and –£25 (95% CI –£268 to £157) for POWeR+R. The probability of being cost-effective at a threshold of £100 per kilogram was 88% and 98% for POWeR+F and POWeR+R, respectively. POWeR+R was dominant compared with the control group. No harms were reported and participants using POWeR+ felt more enabled in managing their weight. The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+.Study limitationsMaintenance of weight loss after 1 year is unknown.Future workIdentifying strategies for longer-term engagement, impact in community settings and increasing physical activity.ConclusionClinically valuable weight loss (> 5%) is maintained in 20% of individuals using novel written materials with brief follow-up. A web-based behavioural programme and brief support results in greater mean weight loss and 10% more participants maintain valuable weight loss; it achieves greater enablement and fewer participants undertaking other weight-loss activities; and it is likely to be cost-effective.Trial registrationCurrent Controlled Trials ISRCTN21244703.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 4. See the NIHR Journals Library website for further project information.


2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Ana Aguiar ◽  
Marta Pinto ◽  
Raquel Duarte

Abstract Background During these unprecedented times, individuals who experience the sudden death of a family member or friend, already miss the anticipatory grief and are now also prevented from a proper farewell. This study aimed to address prolonged grief disorder since the beginning of the COVID-19 pandemic Methods A virtual snowball sampling survey was disseminated through social networking channels. The study enrolled participants from general resident population in Portugal with ≥18 years. Characteristics of the sample were summarized using descriptive statistics. Anxiety and depression symptoms are described by absolute and relative frequencies and compared through the Chi-square test. Results A total of 929 participants completed the survey; 17.9% (n = 166) have lost someone since the beginning of the pandemic, making our final sample. Most were female (66.9%); median age of 35 years and 70.5% had a high education degree. Participants who had lost a grandparent consisted of 28.3% of the sample, father and/or mother 9.0%, and a friend 22.3%. We found a prevalence of 30.7% of anxiety symptoms and 10.2% of depression symptoms (p = 0.030). Also, 16.8% have had a high score on the PG13, which show that these people can mourned for longer periods. Conclusions Paying the last tribute to a loved one is a mental health gesture that allows individuals to make amends and reconcile with life. Key messages The need arises to give timely attention to the psychological consequences due to the COVID-19 pandemic concerning grief


2020 ◽  
Author(s):  
Abhimanyu Kumar ◽  
Govind Prasad ◽  
Sanjay Srivastav ◽  
Vinod Kumar Gautam ◽  
Neha Sharma

Background: Guduchi Ghan Vati (aqueous extract of Tinospora cordifolia) is an essential herbal plant in Indian traditional medicine (Ayurveda) that is well documented as an immunomodulator and antimicrobial agent. A recent in silico study found the therapeutic efficacy of Guduchi against SARS-CoV-2. Based on available evidence, we conducted a feasibility study of the safety and efficacy of Guduchi Ghan Vati in asymptomatic patients with covid-19. Patients and methods: An open label, feasibility trial was conducted on 46 patients in the hospital setting. A single-arm study with no control group and blinding was executed in Jodhpur, Rajasthan, India. All patients orally received 2 tablets (1000 mg) twice daily for 2 weeks. Clinical parameters were collected at baseline, day 3, day 7 and day 14. Patients were continuously monitored for side effects and adverse reactions during the study period. . Results: Out of 46 asymptomatic patients included in the study, 40 completed the 14-day follow-up period. None developed any Covid-19 symptoms after admission to the hospital. On day 3 post-treatment, viral clearance was reported in 16 (32.5%) patients. By the end of D-7, 38 (95%) patients had viral load disappearance. Follow-up at D-14 showed that all participants tested negative. Conclusion: In adult patients with asymptomatic Covid-19, Gudhuchi Ghan Vati could be effective. Randomized controlled trials with larger sample sizes in patients with Covid-19 are urgently needed to confirm the definite benefit with Ayurveda.


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