The Expressive Writing in Bariatric Surgery

NCT04035512 | Unknown DMC

• 1 other identifier: 267116L
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Expressive writing; Obesity; Alexithymia; Adherence

Outcome Measures

Primary Outcomes (3)

• Excess Weight Loss (%EWL)

  Those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%)

  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.

  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).

  3 month

Study Arms (2)

Expressive writing

EXPERIMENTAL

The expressive writing group will perform the writing task, for 3 consecutive days, 20 minutes each day

Other: Expressive writing

Control group

NO INTERVENTION

Any intervention

Interventions

Expressive writing OTHER

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.

Expressive writing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• presence of a psychiatric disorder or drug/ alcohol abuse
• cognitive impairment
• level of education less than primary school
• revisional surgery.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University College London Hospitals: collaborator

Related Publications (17)

• 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.

  PMID: 27852888 BACKGROUND

• 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.

  PMID: 28353096 BACKGROUND

• 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.

  PMID: 30564177 BACKGROUND

• 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.

  PMID: 25680476 BACKGROUND

• Pennebaker 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.

  PMID: 3745650 BACKGROUND

• 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. doi: 10.1097/01.psy.0000116979.77753.74.

  PMID: 15039501 BACKGROUND

• 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. Italian.

  PMID: 25837613 BACKGROUND

• Fried 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.

  PMID: 25263472 BACKGROUND

• 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.

  PMID: 26649192 BACKGROUND

• Taylor GJ. Alexithymia: concept, measurement, and implications for treatment. Am J Psychiatry. 1984 Jun;141(6):725-32. doi: 10.1176/ajp.141.6.725.

  PMID: 6375397 BACKGROUND

• 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.

  PMID: 25832488 BACKGROUND

• 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.

  PMID: 28092189 BACKGROUND

• 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.

  PMID: 20189470 BACKGROUND

• 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.

  PMID: 21833817 BACKGROUND

• Karlsson 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.

  PMID: 17356530 BACKGROUND

• 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.

  PMID: 29497961 BACKGROUND

• 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. doi: 10.1037/0278-6133.23.6.555.

  PMID: 15546223 BACKGROUND

MeSH Terms

Conditions

Obesity; Affective Symptoms

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Gianfranco Silecchia

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianfranco Silecchia

CONTACT

003907736513349; gianfranco.silecchia@uniroma1.it

Laura Pierro

CONTACT

00393299712654; laura.pierro@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Model Details: 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)

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From the recruitment till 4 years after it ends.
• Access Criteria: The data will be managed by the two PhD students involved in the study. All data will be inserted in a an excel database of a University laptop protected from a password. Then, the PhD students will analyze all the data whit an Univariate analysis of variance (ANOVA) on repeated measures in order to test both the difference between the expressive writing group vs control group and the Italian sample vs English sample to verify the hypothesized differences between the groups. Furthermore, correlational models (Pearson r) and predictive models (multivariate regression models) will be performed to verify the associations between the psychological variables, the levels of adherence to treatment and the EWL% reached. To each participant will be assigned a numerical code, in order to guarantee the anonymity.