The Expressive Writing in Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— EWinBSP  

Official title:

The "Expressive Writing" as Psychological Intervention in Bariatric Population. Prospective Longitudinal Multi Centric Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035512
• Other study ID #: 267116L
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2019
• Source: University of Roma La Sapienza
• Contact: Gianfranco Silecchia
• Phone: 003907736513349
• Email: gianfranco.silecchia[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• presence of a psychiatric disorder or drug/ alcohol abuse

• cognitive impairment

• level of education less than primary school

• revisional surgery.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Other:
• Expressive writing
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	University College London Hospitals

References & Publications (17)

Altamura 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. — View Citation

Calia 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. — View Citation

Capoccia D, Coccia F, Guarisco G, Testa M, Rendina R, Abbatini F, Silecchia G, Leonetti F. Long-term Metabolic Effects of Laparoscopic Sleeve Gastrectomy. Obes Surg. 2018 Aug;28(8):2289-2296. doi: 10.1007/s11695-018-3153-8. — View Citation

Figura 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. — View Citation

Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Frühbeck G. [Interdisciplinary European guidelines on metabolic and bariatric surgery]. Rozhl Chir. 2014 Jul;93(7):366-78. Czech. — View Citation

Gallo 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. Review. Italian. — View Citation

Karlsson J, Taft C, Rydén A, Sjöström 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. Epub 2007 Mar 13. — View Citation

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. — View Citation

Livhits 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. Review. — View Citation

Lodhia 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. — View Citation

Norman 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. — View Citation

Palmisano 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. Review. — View Citation

Paone 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. — View Citation

Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. — View Citation

Semanscin-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. — View Citation

Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. Review. — View Citation

Zakowski SG, Ramati A, Morton C, Johnson P, Flanigan R. Written emotional disclosure buffers the effects of social constraints on distress among cancer patients. Health Psychol. 2004 Nov;23(6):555-63. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess Weight Loss (%EWL)	Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%)	3 month
Primary	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.	3 month
Primary	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).	3 month