Telecare CBT for Morbid Obesity
Results at the moment: - pre-study (feasibility study) complete - written research protocol - study approved by REC Status of the project: The study proposed in this project was initially to be conducted at UNN in the department of Gastroenteritis and Nutrition. The project manager, Artur Serrano was a researcher at the NST and the execution of the clinical procedures was to be performed by Dr. Samira Lekhal, under the clinical responsibility of the leader of the department, Prof. Jon Floreholmen. However, in 2012 Dr. Samira Lekhal quit her job at UNN and after several attempts, it was impossible to find a suitable replacement at UNN. For that reason it was decided to establish a collaboration with the Evjeklinniken, located in Evje, Aust-Agder. The clinic had an agreement with Helse Nord for the treatment of obesity patients. During 2013 collaboration agreement was established between UNN and the Evjeklinniken to execute the project and coordinate a RCT study with patients from UNN. At this time the nurse Konstantinos Antypas was appointed as the link between UNN and Evjeklinniken. A new ethics protocol was subsequently submitted and approved by REC. However, in 2014, the agreement between UNN and Evjeklinniken was interrupted with the consequence that no patients were sent to treatment. This stopped the study and the project. Also, the main link between UNN and the Evjeklinninken, Konstantinos Antypas left NST. During 2015, because of the reorganization of NST into the new centre, it was not possible to hire a replacement for the execution of the project. At the moment, the situation at the new Centre for E-Health Research is not yet stable in terms of human resources and it is unclear how to proceed, so it was decided together with the leadership, namely the department leader Siri Bjørvig and the Centre leader Line Linstad, to close the project. As the idea is still of research relevance and politically meaningful, and since there is already ethical approval and a research protocol, we intend to apply for a new edition of the project in September.
The produced research protocol which got ethical approval, can be used by other projects to conduct a RCT. The growing prevalence of morbid obesity in Norway, with great impact in Northern Norway, with consequent high societal costs, has placed obesity treatments as a high priority in the Norwegian health services. Bariatric surgery is progressively becoming a widespread treatment for obesity. In Northern Norway the capacity to provide this intervention is lower than the demands and the waiting lists are growing. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking [PMCID: PMC4687869]. Due to the risks it entails and the high cost of this intervention, the prescription of this bariatric surgery is usually considered carefully and looked at with some precautions. The project proposes a secondary prevention strategy that may be considered as alternative to bariatric surgery. The use of Cognitive-Behavioural Therapy (CBT) is studied in the preventive, non-invasive, non-pharmacological, and ambulatory (outpatient based) treatment of morbid obesity. Primary outcomes are 1) Better clinical outcomes with no increase of cost; 2) An improvement of weight reduction success rates. If a positive result is found, the employment of an expensive and risky procedure such is bariatric surgery, could eventually be reduced. Due to a reduced involvement of medical resources, waiting lists could be reduced or eliminated. Both direct costs (treatment) of CBT when compared to surgery and indirect costs (waiting lists and unemployment benefits, recovery time, rehabilitation procedures, traveling) are substantially lower. In addition, CBT has less impact to the patient than surgery.
Telecare CBT for Morbid Obesity
The NST together with the rehabilitation clinic Evjeklinikken, in Evje, will conduct a RCT where telecare is used to deliver CBT (Cognitive Behavioural Therapy) based on tablets with video calling for obesity treatment.
For reference a summary of the study is given below. The full study protocol can be delivered if requested. Under the coordination of NST (Norwegian Centre for Integrated Care and Telemedicine), a RCT will be conducted at the Evjeklinikken premises where telecare will be used to deliver CBT based on tablets with video calling for obesity treatment. The study which aims at finding if it is possible to achieve: 1) Better clinical outcomes with no increase of cost; 2) An improvement of weight reduction success rates. Due to the increase in the communication between the patients and healthcare staff introduced by the project, the new intervention will improve care and is foreseen to create a context of extra safety for the patients. As mentioned in last year's report, the study is ready for starting with recruitment of patients. A total of 120 patients, randomly distributed into an intervention arm and a control arm, will be recruited. During 2014 the main collaborator in this Project, Konstaninos Antypas, was not able to work in the Project. During the first months he was finalizing his doctoral thesis and after defending he quit his position at NST. For this reason the Project has been in a pause. At the moment there are no available Resources at NST to replace Konstantinos. A solution is being searched by involving external resources specially in the collection and treatment of data. Whatever the solution will be, the Research protocol will not be changed. An extension of the Project duration will have to be approved by REK.
Telecare CBT for Morbid Obesity
Complete title: Telecare CBT for Morbid Obesity: A clinical trial of a solution for telecare enhanced Cognitive Behavioural Therapy for the treatment of obesity.
The NST together with the Evjeklinikken will conduct a RCT where telecare is used to deliver CBT (Cognitive Behavioural Therapy) based on tablets with video calling for obesity treatment.
Video-conference technology has been used successfully in several studies concerning different pathologies. In the proposed project, morbidly obese patients will participate in a RCT where a telecare approach will provide intensified delivery of CBT to the patient at home using video-call on tablets.
The study aims at finding if it is possible to achieve:
1) Better clinical outcomes with no increase of cost;
2) An improvement of weight reduction success rates.
Due to the increase in the communication between the patients and healthcare staff introduced by the project, the new intervention will improve care and is foreseen to create a context of extra safety for the patients.
The main milestones achieved during this reporting period (2013) are listed below:
1. The definition of the study protocol in collaboration with the Evjeklinikken
The patients for the trial will be followed at the Evjeklinikken as there no funding at the initial site (Centre for the Morbid Obesity SSO (Senter for sykelig overvekt) at UNN) to conduct the study. The patients are still referred to Evjeklinikken by Helse Nord, but the health personnel conducting the study will be located at the Evjeklinikken. A copy of the study protocol can be provided.
2. The integration between the system proposed by NST with the one in operation at the Evjeklinikken
The web-based platform developed at the Evjeklinikken for patient-clinic staff interaction will be used in parallel to the RCT study. However the information collected in the study wil conform to the protocol submitted and approved by REC.
3. The creation of a web-version of the patient questionnaire
A patient questionnaire has been developed for the web. This questionnaire is based on a weight-loss behaviour scale (WLBS) - see below. The technical platform used was Google spreadsheets.
4. Elaboration of a CBT strategy
CBT (Cognitive Behavioural Therapy) approaches to treatment of morbid obesity has proven effective at changing related behaviours. However, official guidelines for treatment of obesity from the Sosial- og helsedirektoratet indicate that CBT should not be performed in the absence of other significant treatment approaches, including lifestyle changes. CBT procedures have been successfully implemented by use of ICT for a range of health problems, including increasing physical activity, mental health, etc. Interventions related to weight loss have also been implemented through ICT. There is little reason to believe that the CBT procedure cannot be implemented by ICT.
Tablet based CBT (tablet-CBT)
The tablet-based procedure requires a structured pre-consultation. Structuring will be based on patients’ responses to a weight-loss behaviour scale (WLBS) completed between sessions. The WLBS translated and currently used by SSO will be used. WLBS measures attitudes and experiences on four sub-scales:
A) weight loss and dieting, B) physical activity, C) emotional eating, D) overeating
The patient scores each question in the sub-scale and then the highest scored sub-scales will be given priority during the CBT sessions.
Plan for 2014:
The study is now ready for starting with recruitment of patients. The patients, having a BMI over 40 kg/m2, will be randomly distributed into an intervention arm (60 patients) and a control arm. 120 in total considering the control arm. Between 50 and 70 are expected to enrol during 2014.
Telecare CBT for Morbid Obesity : A clinical trial
NST (Norwegian Centre for Integrated Care and Telemedicine) and the Evjeklinniken will coordinate a RCT with patients from UNN, where a telecare approach using video communication on tablet units will be used to deliver CBT (Cognitive Behavioural Therapy) for the treatment of morbidly obese patients.
Obesity and overweight is a major risk for serious diet-related chronic diseases, including type II diabetes, cardiovascular disease, hypertension and stroke, and certain forms of cancer. It is at the moment the third leading risk for global deaths in high-income countries and the fifth worldwide (WHO 2009). According to WHO in 2012 “more than 1,4 billion adults are overweight – and around 500 million of them are clinically obese”. WHO further projects that by 2015, approximately 2.3 billion adults will be overweight and more than 700 million will be obese. The prevalence of overweight and obesity is commonly assessed by using body mass index (BMI), defined as the weight in kilograms divided by the square of the height in metres. A BMI over 25 kg/m2 is defined as overweight, a BMI of over 30 kg/m2 as obese, and a BMI over 40 kg/m2 as morbidly obese. Northern Norway has a higher obesity (11.3%) and overweight (38.4%) prevalence than the general population of Norway (10% and 35%, respectively).
The intervention planned for this study will have a telecare solution based on mobile phones (or tablets) with video calling capabilities, to deliver Cognitive Behavioural Therapy (CBT). A methodology was developed to prepare a RCT. A nurse at UNN was trained to perform the CBT sessions. Before the RCT, a feasibility of the methodology was tested in a small study performed under real clinical context. A research team from the NST (Norwegian Centre for Integrated Care and Telemedicine) of the University Hospital of North Norway, coordinated by Prof. Artur Serrano, conducted the study. The study was performed under the supervision of the director of the department of Gastroenterology and Nutrition of the same hospital, Prof. Jon Floreholmen.
During the feasibility study the patients were provided with a tablet phone (Samsung Galaxy tab) for the video calls. For the feasibility study, two patients, one male and one female, satisfying the inclusion criteria and involved in the current care at the hospital, a nurse and a doctor were asked to test the approach. The procedure included a weekly CBT session performed on a video call. The patients were asked to fill in a web based WLBS accessible by a browser on the same tablet phone. This scale should be revisited previously to each of the CBT sessions. The scale is targeting the patient’s attitude during that week regarding his or her nutrition and exercise. The provided WLBS was then used by the nurse as a support during the CBT session in the video call with the patient. The study had 3 months duration. The study was mainly qualitative with focus on the clinical, economical, technological aspects. This study demonstrates the feasibility of the approach and gives evidence to support a large RCT. The planned RCT will include a total of 120 patients recruited during this year (60 in the intervention arm and 60 in the control arm). Clinical outcomes will be measured at baseline, 6 and 12 months after recruitment. The patients are recruited from UNN. The study will have a follow-up period of 12 months and initial scientific results are expected to be obtained and published just after the Summer 2013.
Telecare kognitiv ardferdsterapi for sykelig fedme
Formålet med prosjektet er å undersøke om CBT (Cognitive Behavioural Therapy) - samtaler via bildetelefon en gang per uke, er mer effektivt enn bare vanlig behandling for pasienter med en BMI over 40. CBT er en kombinasjon av kognitive og atferdsmessige teknikker for å behandle psykiske lidelser. Det skal inkluderes totalt 100 deltakere i studien.
En undersøkelse gjennomført i Nord-Norge for en befolkning i aldersgruppen over 16 år har vist at forekomsten av overvektig og ekstreme overvektig (eller sykelig fedme) folk er lik 49,0 og 11,3%, henholdsvis. CBT (Cognitive Behavioural Therapy eller kognitiv atferdsforskning terapi, på norsk) er en sammenslåing av kognitive og atferdsmessige teknikker for å behandle psykiske lidelser. Det er fokusert på å endre uhensiktsmessig atferd og de tanker som bidrar til å opprettholde denne atferden. Denne studien er en RCT som skal utføres ved UNN Gastroenterologi avdelingen. Et minimum av 100 pasienter med en BMI høyere enn 40 vil være involvert, og hver pasient vil bli engasjert for en periode av 12 måneder. Gjeldende behandling består av ansikt til ansikt CBT økter med en utdannet sykepleier ved UNN. I studien vil 50 pasienter bli plassert i en kontrollgruppe der de vil få den gjeldende behandling og 50 pasienter vil være i intervensjonsgruppen og vil motta den samme behandling og i tillegg vil få ekstra CBT økter fra en sykepleier gjennom en personlig bildetelefon hver uke. Inklusjonskriterier som per dagens behandling er: alder mellom 18 og 65 år, fedme ifølge WHO kriterier (BMI = 40), informertsamtykke til å delta. Disse pasientene er de som blir henvist til UNN Gastroenterologi avdelingen CBT behandling.
CBT vil bli levert gjennom bildetelefon, og utført i samsvar med norske nasjonale retningslinjer for behandling av sykelig fedme. CBT økter vil fokusere spesielt på sentrale områder som identifiseres ved Weight Loss Behavior Scale (WLBS) som oversettes og i dag brukes av UNN (se nedenfor). WLBS dataverdier vil bli innspill av pasienten før CBT økten til en online anonymt spørreskjema og dette vil nås av sykepleieren og diskutert under CBT økten med pasienten. WLBS gjelder holdninger og erfaringer på fire sub-skalaer:
• Holdning til egen vekt og diett.
• Holdning til fysisk aktivitet.
• Holdning til emosjonelt inntak av mat.
• Holdning til overspising.
Både positive og negative høyeste scoret sub-skalaer vil bli prioritert under CBT økter, .
For spesielt positive score, vil vellykkede mestringsstrategier styrkes og fremmes hvis aktuelt. For negativ score, vil generelle prinsipper om CBT opprettholdes, herunder adressering negative tankemønstre.
Studien målet er å undersøke om levering av økt CBT via bildetelefon vil forbedre behandlingen resultater sammenlignet med dagens utfall.