Bariatric Surgery CandidateEWinBSPNCT04035512
The Expressive Writing in Bariatric Surgery
A study testing Expressive writing in people with Bariatric Surgery Candidate, run by University of Roma La Sapienza.
Trial summary
The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Expressive writing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria will follow the European Guidelines on Metabolic and Bariatric Surgery (Fried et al., 2014):
- With BMI ≥ 40 kg/m2, with BMI 35-40 kg/m2 with co-morbidities in which surgically induced weight loss is expected to improve the disorder
- declared eligible for pre-operative psychological assessment.
Who cannot join
- presence of a psychiatric disorder or drug/ alcohol abuse
- cognitive impairment
- level of education less than primary school
- revisional surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The "Expressive Writing" as Psychological Intervention in Bariatric Population. Prospective Longitudinal Multi Centric Study
The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively.
All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed.
The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.
Read the detailed description
Obesity is a multifactorial disease characterized by genetic, social, cultural and psychological factors. Its complex nature requires a multidisciplinary intervention in order to guarantee an optimal outcome. Currently, laparoscopic bariatric surgery represents the gold standard intervention to treat morbid obesity and related comorbidities, as well as to improve quality of life. The expected Excess Weight Loss (%EWL) after the most popular bariatric procedures ranges between 60% and 70%, respectively at 1 and 2 years after surgery. However, literature shows that more than 30% of bariatric patients do not reach the expected weight loss and up to one third regain substantial weight in the long term period. Several studies showed correlation between post-surgery weight loss or %EWL and personality disorders, eating disorders, mood disorders and anxiety disorder. Also childhood traumatic experiences, that could be associated to the development of obesity, had a role in weight loss after surgery and in affecting emotional regulation. Recent studies also showed the role of emotional regulation and in particular as the difficulty in identifying and describing emotions, known as "alexithymia", was associated respectively to lower %Total Weight Loss at 3 and 6 months after gastric bypass and at 12 months after laparoscopic sleeve gastrectomy.
Considering the influence of alexithymia on people living with obesity seeking a weight loss program, it is conceivable that an intervention focused on emotional state could improve outcome after surgery in term of weight loss.
The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and difficult experience for 15-20 min for 3-5 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. It is conceivable that the externalization and the processing of the traumatic events linked to the disease, can favor an improvement of the ability of express emotions and the reduction of the negative thoughts associated.
Recruitment: all patients, considered eligible after a multidisciplinary assessment, will be contacted to request participation in the study. Those who accepted the participation, will be randomized in two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. Then all the participants of both groups will complete the informed consent and the questionnaires 3 days before surgery (T0).
According to the randomized recruitment all patients of the expressive writing group will be scheduled for 3 consecutive days (20 minutes each day) on which they will complete the writing task. The procedure for the writing group will be as follow:
on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.
The above method was previously tested by Zakowski et al., 2004. The control group (no expressive writing) will just complete the above mentioned questionnaires.
Both groups will fill the same questionnaires also at 3 months follow up (T1). In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected according to the blood analysis provided for the hospital protocol of bariatric surgery.
Moreover, the adherence to follow up visits (surgical and nutritional) at 1 and 3 months will be assessed.
The weight measures at T0, and T1 will be collected in order to test the EWL% reached in both groups.
The present study has been approved by the Ethics Committee of the Department of Dynamic and Clinical Psychology "Sapienza" University of Rome on April 3rd, 2019.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Expressive writing
- Keywords
- Bariatric surgery, Expressive writing, Obesity, Alexithymia, Adherence
- Medical subject headings
- Obesity, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingOther
The procedure for the writing group will be as follow:
on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.
The above method was previously tested by Zakowski et al., 2004.
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing | Experimental | The expressive writing group will perform the writing task, for 3 consecutive days, 20 minutes each day Receives: Other: Expressive writing |
| Control group | No intervention | Any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess Weight Loss (%EWL)
Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%)
Measured: 3 month
Emotional Regulation (Toronto Alexithymia Scale)
The TAS-20 is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (> 60), not alexithymic (< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (<51) compared to control group patients.
Measured: 3 month
Adherence (Visual Analogue Scale)
The VAS asks individuals to mark a line at the point along a continuum showing how much of each drug they have taken in the past 6 months from 0% to 100% where 0% means you have taken no drug/s in the past 6 months, 50% means you have taken half of your drug/s in the past 6 months and 100% means you have taken all of your drug/s in the past 6 months. After surgery it will be used also to assess the adherence to nutritional supplements provided by the bariatric protocol. We expect that those patients undergoing expressive writing would have a higher level of adherence to treatment on VAS score (>90).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The sample will be divided into two group, in a randomized way. The expressive writing group that will perform the writing task and the control group that will not perform the writing task. The study includes two measurements, pre-operatively (T0) and 3 months after surgery (T1)
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Principal investigator, Gianfranco Silecchia, University of Roma La Sapienza
- Investigators
- Gianfranco Silecchia, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035512
- Sponsor's protocol ID
- 267116L
- Acronym
- EWinBSP
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The personal data will be managed only by the two PhD students involved in this research.
Publications
Lai C, Aceto P, Petrucci I, Castelnuovo G, Callari C, Giustacchini P, Sollazzi L, Mingrone G, Bellantone R, Raffaelli M. The influence of preoperative psychological factors on weight loss after bariatric surgery: A preliminary report. J Health Psychol. 2019 Mar;24(4):518-525. doi: 10.1177/1359105316677750. Epub 2016 Nov 16.
PubMed 27852888Paone E, Pierro L, Damico A, Aceto P, Campanile FC, Silecchia G, Lai C. Alexithymia and weight loss in obese patients underwent laparoscopic sleeve gastrectomy. Eat Weight Disord. 2019 Feb;24(1):129-134. doi: 10.1007/s40519-017-0381-1. Epub 2017 Mar 28.
PubMed 28353096Altamura M, Porcelli P, Fairfield B, Malerba S, Carnevale R, Balzotti A, Rossi G, Vendemiale G, Bellomo A. Alexithymia Predicts Attrition and Outcome in Weight-Loss Obesity Treatment. Front Psychol. 2018 Dec 4;9:2432. doi: 10.3389/fpsyg.2018.02432. eCollection 2018.
PubMed 30564177Calia R, Lai C, Aceto P, Luciani M, Camardese G, Lai S, Fantozzi C, Pietroni V, Salerno MP, Spagnoletti G, Pedroso JA, Romagnoli J, Citterio F. Emotional self-efficacy and alexithymia may affect compliance, renal function and quality of life in kidney transplant recipients: results from a preliminary cross-sectional study. Physiol Behav. 2015 Apr 1;142:152-4. doi: 10.1016/j.physbeh.2015.02.018. Epub 2015 Feb 11.
PubMed 25680476Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available.
PubMed 3745650Norman SA, Lumley MA, Dooley JA, Diamond MP. For whom does it work? Moderators of the effects of written emotional disclosure in a randomized trial among women with chronic pelvic pain. Psychosom Med. 2004 Mar-Apr;66(2):174-83. doi: 10.1097/01.psy.0000116979.77753.74.
PubMed 15039501Gallo I, Garrino L, Di Monte V. [The use of expressive writing in the course of care for cancer patients to reduce emotional distress: analysis of the literature]. Prof Inferm. 2015 Jan-Mar;68(1):29-36. doi: 10.7429/pi.2015.681029. Italian.
PubMed 25837613Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Fruhbeck G. [Interdisciplinary European guidelines on metabolic and bariatric surgery]. Rozhl Chir. 2014 Jul;93(7):366-78. Czech.
PubMed 25263472Figura A, Ahnis A, Stengel A, Hofmann T, Elbelt U, Ordemann J, Rose M. Determinants of Weight Loss following Laparoscopic Sleeve Gastrectomy: The Role of Psychological Burden, Coping Style, and Motivation to Undergo Surgery. J Obes. 2015;2015:626010. doi: 10.1155/2015/626010. Epub 2015 Nov 15.
PubMed 26649192Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. doi: 10.1176/ajp.141.6.725.
PubMed 6375397Lodhia NA, Rosas US, Moore M, Glaseroff A, Azagury D, Rivas H, Morton JM. Do adverse childhood experiences affect surgical weight loss outcomes? J Gastrointest Surg. 2015 Jun;19(6):993-8. doi: 10.1007/s11605-015-2810-7. Epub 2015 Apr 2.
PubMed 25832488Palmisano GL, Innamorati M, Vanderlinden J. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review. J Behav Addict. 2016 Mar;5(1):11-31. doi: 10.1556/2006.5.2016.018.
PubMed 28092189Semanscin-Doerr DA, Windover A, Ashton K, Heinberg LJ. Mood disorders in laparoscopic sleeve gastrectomy patients: does it affect early weight loss? Surg Obes Relat Dis. 2010 Mar 4;6(2):191-6. doi: 10.1016/j.soard.2009.11.017. Epub 2010 Jan 1.
PubMed 20189470Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, Ko CY, Gibbons MM. Preoperative predictors of weight loss following bariatric surgery: systematic review. Obes Surg. 2012 Jan;22(1):70-89. doi: 10.1007/s11695-011-0472-4.
PubMed 21833817Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13.
PubMed 17356530
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Expressive Writing" as Psychological Intervention in Bariatric Population. Prospective Longitudinal Multi Centric Study
- ClinicalTrials.gov ID
- NCT04035512
- Acronym / sponsor ID
- EWinBSP / 267116L
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric surgery, Expressive writing, Obesity, Alexithymia, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively.
All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed.
The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.
Detailed description
Obesity is a multifactorial disease characterized by genetic, social, cultural and psychological factors. Its complex nature requires a multidisciplinary intervention in order to guarantee an optimal outcome. Currently, laparoscopic bariatric surgery represents the gold standard intervention to treat morbid obesity and related comorbidities, as well as to improve quality of life. The expected Excess Weight Loss (%EWL) after the most popular bariatric procedures ranges between 60% and 70%, respectively at 1 and 2 years after surgery. However, literature shows that more than 30% of bariatric patients do not reach the expected weight loss and up to one third regain substantial weight in the long term period. Several studies showed correlation between post-surgery weight loss or %EWL and personality disorders, eating disorders, mood disorders and anxiety disorder. Also childhood traumatic experiences, that could be associated to the development of obesity, had a role in weight loss after surgery and in affecting emotional regulation. Recent studies also showed the role of emotional regulation and in particular as the difficulty in identifying and describing emotions, known as "alexithymia", was associated respectively to lower %Total Weight Loss at 3 and 6 months after gastric bypass and at 12 months after laparoscopic sleeve gastrectomy.
Considering the influence of alexithymia on people living with obesity seeking a weight loss program, it is conceivable that an intervention focused on emotional state could improve outcome after surgery in term of weight loss.
The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and difficult experience for 15-20 min for 3-5 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. It is conceivable that the externalization and the processing of the traumatic events linked to the disease, can favor an improvement of the ability of express emotions and the reduction of the negative thoughts associated.
Recruitment: all patients, considered eligible after a multidisciplinary assessment, will be contacted to request participation in the study. Those who accepted the participation, will be randomized in two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively. Then all the participants of both groups will complete the informed consent and the questionnaires 3 days before surgery (T0).
According to the randomized recruitment all patients of the expressive writing group will be scheduled for 3 consecutive days (20 minutes each day) on which they will complete the writing task. The procedure for the writing group will be as follow:
on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.
The above method was previously tested by Zakowski et al., 2004. The control group (no expressive writing) will just complete the above mentioned questionnaires.
Both groups will fill the same questionnaires also at 3 months follow up (T1). In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected according to the blood analysis provided for the hospital protocol of bariatric surgery.
Moreover, the adherence to follow up visits (surgical and nutritional) at 1 and 3 months will be assessed.
The weight measures at T0, and T1 will be collected in order to test the EWL% reached in both groups.
The present study has been approved by the Ethics Committee of the Department of Dynamic and Clinical Psychology "Sapienza" University of Rome on April 3rd, 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample will be divided into two group, in a randomized way. The expressive writing group that will perform the writing task and the control group that will not perform the writing task. The study includes two measurements, pre-operatively (T0) and 3 months after surgery (T1)
| Arm | Type | Receives |
|---|---|---|
| Expressive writing | Experimental | Other: Expressive writingThe expressive writing group will perform the writing task, for 3 consecutive days, 20 minutes each day |
| Control group | No intervention | –Any intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The inclusion criteria will follow the European Guidelines on Metabolic and Bariatric Surgery (Fried et al., 2014):
Key exclusion criteria (4 listed)
- presence of a psychiatric disorder or drug/ alcohol abuse
- cognitive impairment
- level of education less than primary school
- revisional surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingThe procedure for the writing group will be as follow: on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical. The above method was previously tested by Zakowski et al., 2004. | Other | Expressive writing |
Primary outcome
Excess Weight Loss (%EWL)
Time frame: 3 month
Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%)
Emotional Regulation (Toronto Alexithymia Scale)
Time frame: 3 month
The TAS-20 is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (> 60), not alexithymic (< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (<51) compared to control group patients.
Adherence (Visual Analogue Scale)
Time frame: 3 month
The VAS asks individuals to mark a line at the point along a continuum showing how much of each drug they have taken in the past 6 months from 0% to 100% where 0% means you have taken no drug/s in the past 6 months, 50% means you have taken half of your drug/s in the past 6 months and 100% means you have taken all of your drug/s in the past 6 months. After surgery it will be used also to assess the adherence to nutritional supplements provided by the bariatric protocol. We expect that those patients undergoing expressive writing would have a higher level of adherence to treatment on VAS score (>90).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 27852888Lai C, Aceto P, Petrucci I, Castelnuovo G, Callari C, Giustacchini P, Sollazzi L, Mingrone G, Bellantone R, Raffaelli M. The influence of preoperative psychological factors on weight loss after bariatric surgery: A preliminary report. J Health Psychol. 2019 Mar;24(4):518-525. doi: 10.1177/1359105316677750. Epub 2016 Nov 16.
- Background: PubMed 28353096Paone E, Pierro L, Damico A, Aceto P, Campanile FC, Silecchia G, Lai C. Alexithymia and weight loss in obese patients underwent laparoscopic sleeve gastrectomy. Eat Weight Disord. 2019 Feb;24(1):129-134. doi: 10.1007/s40519-017-0381-1. Epub 2017 Mar 28.
- Background: PubMed 30564177Altamura M, Porcelli P, Fairfield B, Malerba S, Carnevale R, Balzotti A, Rossi G, Vendemiale G, Bellomo A. Alexithymia Predicts Attrition and Outcome in Weight-Loss Obesity Treatment. Front Psychol. 2018 Dec 4;9:2432. doi: 10.3389/fpsyg.2018.02432. eCollection 2018.
- Background: PubMed 25680476Calia R, Lai C, Aceto P, Luciani M, Camardese G, Lai S, Fantozzi C, Pietroni V, Salerno MP, Spagnoletti G, Pedroso JA, Romagnoli J, Citterio F. Emotional self-efficacy and alexithymia may affect compliance, renal function and quality of life in kidney transplant recipients: results from a preliminary cross-sectional study. Physiol Behav. 2015 Apr 1;142:152-4. doi: 10.1016/j.physbeh.2015.02.018. Epub 2015 Feb 11.
- Background: PubMed 3745650Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available.
- Background: PubMed 15039501Norman SA, Lumley MA, Dooley JA, Diamond MP. For whom does it work? Moderators of the effects of written emotional disclosure in a randomized trial among women with chronic pelvic pain. Psychosom Med. 2004 Mar-Apr;66(2):174-83. doi: 10.1097/01.psy.0000116979.77753.74.
- Background: PubMed 25837613Gallo I, Garrino L, Di Monte V. [The use of expressive writing in the course of care for cancer patients to reduce emotional distress: analysis of the literature]. Prof Inferm. 2015 Jan-Mar;68(1):29-36. doi: 10.7429/pi.2015.681029. Italian.
- Background: PubMed 25263472Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Fruhbeck G. [Interdisciplinary European guidelines on metabolic and bariatric surgery]. Rozhl Chir. 2014 Jul;93(7):366-78. Czech.
- Background: PubMed 26649192Figura A, Ahnis A, Stengel A, Hofmann T, Elbelt U, Ordemann J, Rose M. Determinants of Weight Loss following Laparoscopic Sleeve Gastrectomy: The Role of Psychological Burden, Coping Style, and Motivation to Undergo Surgery. J Obes. 2015;2015:626010. doi: 10.1155/2015/626010. Epub 2015 Nov 15.
- Background: PubMed 6375397Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. doi: 10.1176/ajp.141.6.725.
- Background: PubMed 25832488Lodhia NA, Rosas US, Moore M, Glaseroff A, Azagury D, Rivas H, Morton JM. Do adverse childhood experiences affect surgical weight loss outcomes? J Gastrointest Surg. 2015 Jun;19(6):993-8. doi: 10.1007/s11605-015-2810-7. Epub 2015 Apr 2.
- Background: PubMed 28092189Palmisano GL, Innamorati M, Vanderlinden J. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review. J Behav Addict. 2016 Mar;5(1):11-31. doi: 10.1556/2006.5.2016.018.
- Individual participant dataSharing planned: Yes. The personal data will be managed only by the two PhD students involved in this research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Silecchia principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Bariatric Surgery Candidate, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Silecchia (003907736513349, gianfranco.silecchia@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess Weight Loss (%EWL) (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035512, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.