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BMC Primary Care
Published in: BMC Primary Care 1/2015

Open Access 01-12-2015 | Study protocol

Effectiveness of a PLISSIT model intervention in patients with type 2 diabetes mellitus in primary care: design of a cluster-randomised controlled trial

Authors: Anne Rutte, Patricia van Oppen, Giel Nijpels, Frank J. Snoek, Paul Enzlin, Peter Leusink, Petra J. M. Elders

Published in: BMC Primary Care | Issue 1/2015

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Abstract

Background

Sexual dysfunction is prevalent in patients with type 2 diabetes mellitus, but remains one of the most frequently neglected complications in diabetes care. Both patients and care providers appear to have difficulty with discussing sexual problems in diabetes care. A sexual counselling model for care providers, such as the PLISSIT model, might be a useful tool to improve the discussion of sexual issues in patients with type 2 diabetes mellitus. PLISSIT stands for Permission, Limited Information, Specific Suggestions, and Intensive Therapy. Even though the use of the PLISSIT model has often been recommended in diabetes care, no evidence with regards to its effectiveness in patients with type 2 diabetes mellitus exists. This study describes the design of a cluster-randomised controlled trial evaluating the effectiveness of a PLISSIT-model intervention in men and women with type 2 diabetes mellitus in primary care.

Methods/Design

Patients with type 2 diabetes mellitus, aged 40–75 years, who indicate to be dissatisfied about their sexual functioning and that they would like to talk about their sexual problem(s) with their general practitioner are recruited. All participants receive an information leaflet from the practice nurse. In the intervention group, each participant will also receive sexual counselling based on the PLISSIT model from their general practitioner. In the control group, usual care will be provided to those participants requesting an appointment with their general practitioner when the information leaflet was not deemed sufficient. Primary outcomes include sexual functioning, satisfaction about sexual function, and quality of life. Secondary outcomes are depressive symptoms, sexual distress, emotional well-being, and treatment satisfaction. Outcomes will be measured by means of self-report questionnaires at baseline, and after 3 and 12 months post-baseline. Treatment satisfaction will be assessed in telephone interviews.

Discussion

This paper describes the design of a cluster-randomised controlled trial that will investigate the effectiveness of a PLISSIT-model intervention in patients with type 2 diabetes mellitus in primary care. Our study will add important and currently missing insight into the effectiveness of PLISSIT on important patient-reported outcomes of men and women with type 2 diabetes mellitus.

Trial registration

Dutch Trial Registry NTR4807.
Literature
1.
Giraldi A, Kristensen E. Sexual dysfunction in women with diabetes mellitus. J Sex Res. 2010;47:199–211.CrossRefPubMed
2.
3.
Bargiota A, Dimitropoulos K, Tzortzis V, Koukoulis GN. Sexual dysfunction in diabetic women. Hormones (Athens). 2011;10:196–206.CrossRefPubMed
4.
Fedele D, Coscelli C, Santeusanio F, Bortolotti A, Chatenoud L, Colli E, et al. Erectile dysfunction in diabetic subjects in Italy. Gruppo Italiano Studio Deficit Erettile nei Diabetici. Diabetes Care. 1998;21:1973–7.CrossRefPubMed
5.
Fedele D, Bortolotti A, Coscelli C, Santeusanio F, Chatenoud L, Colli E, et al. Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici. Int J Epidemiol. 2000;29:524–31.CrossRefPubMed
6.
Grover SA, Lowensteyn I, Kaouache M, Marchand S, Coupal L, DeCarolis E, et al. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006;166:213–9.CrossRefPubMed
7.
Malavige LS, Jayaratne SD, Kathriarachchi ST, Sivayogan S, Fernando DJ, Levy JC. Erectile dysfunction among men with diabetes is strongly associated with premature ejaculation and reduced libido. J Sex Med. 2008;5:2125–34.CrossRefPubMed
8.
Lu CC, Jiann BP, Sun CC, Lam HC, Chu CH, Lee JK. Association of glycemic control with risk of erectile dysfunction in men with type 2 diabetes. J Sex Med. 2009;6:1719–28.CrossRefPubMed
9.
Rutte A, van Splunter M, van der Heijden A, Welschen L, Elders P, Dekker J, et al. Prevalence and correlates of sexual dysfunction in Men and women with type 2 diabetes. J Sex Marital Ther. 2014;1–10.
10.
El-Sakka AI. Premature ejaculation in non-insulin-dependent diabetic patients. Int J Androl. 2003;26:329–34.CrossRefPubMed
11.
Corona G, Giorda CB, Cucinotta D, Guida P, Nada E. Sexual dysfunction at the onset of type 2 diabetes: the interplay of depression, hormonal and cardiovascular factors. J Sex Med. 2014;11:2065–73.CrossRefPubMed
12.
Doruk H, Akbay E, Cayan S, Akbay E, Bozlu M, Acar D. Effect of diabetes mellitus on female sexual function and risk factors. Syst Biol Reprod Med. 2005;51:1–6.
13.
Erol B, Tefekli A, Ozbey I, Salman F, Dincag N, Kadioglu A, et al. Sexual dysfunction in type II diabetic females: a comparative study. J Sex Marital Ther. 2002;28 Suppl 1:55–62.CrossRefPubMed
14.
Fatemi SS, Taghavi SM. Evaluation of sexual function in women with type 2 diabetes mellitus. Diab Vasc Dis Res. 2009;6:38–9.CrossRefPubMed
15.
Meeking DR, Fosbury JA, Cummings MH. Sexual dysfunction and sexual health concerns in women with diabetes. Practical Diabetes. 2013;30:327-31a.
16.
Bovée B, Lagro-Janssen T, Vergeer M. Seksuele problemen en hulpvraaggedrag bij diabetici, hypertensieven en patiënten met chronische obstructieve longziekten in een huisartspraktijk. T Seksuologie. 2004;28:134–9.
17.
De Berardis G, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, et al. Erectile dysfunction and quality of life in type 2 diabetic patients: a serious problem too often overlooked. Diabetes Care. 2002;25:284–91.CrossRefPubMed
18.
De Berardis G, Pellegrini F, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, et al. Longitudinal assessment of quality of life in patients with type 2 diabetes and self-reported erectile dysfunction. Diabetes Care. 2005;28:2637–43.CrossRefPubMed
19.
Penson DF, Latini DM, Lubeck DP, Wallace KL, Henning JM, Lue TF. Do impotent men with diabetes have more severe erectile dysfunction and worse quality of life than the general population of impotent patients? Results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction (ExCEED) database. Diabetes Care. 2003;26:1093–9.CrossRefPubMed
20.
Enzlin P, Mathieu C, Van den Bruel A, Bosteels J, Vanderschueren D, Demyttenaere K. Sexual dysfunction in women with type 1 diabetes: a controlled study. Diabetes Care. 2002;25:672–7.CrossRefPubMed
21.
Rutten GEHM, De Grauw WJC, Nijpels G, Houweling ST, Van de Laar FA, Bilo HJ, et al. NHG-Standaard Diabetes mellitus type 2 (derde herziening). Huisarts Wet. 2013;56:512–25.
22.
Verschuren JEA, Enzlin P, Dijkstra PU, Geertzen JHB, Dekker R. Chronic disease and sexuality: a generic conceptual framework. J Sex Res. 2010;47:153–70.CrossRefPubMed
23.
Rutte A, Welschen L, van Splunter M, Schalkwijk A, De Vries L, Snoek F, et al. Type 2 diabetes patients' needs and preferences for care concerning sexual problems: a cross-sectional survey and qualitative interviews. J Sex Marital Ther. 2015.
24.
Jiann BP, Lu CC, Lam HC, Chu CH, Sun CC, Lee JK. Patterns and their correlates of seeking treatment for erectile dysfunction in type 2 diabetic patients. J Sex Med. 2009;6:2008–16.CrossRefPubMed
25.
Gott M, Galena E, Hinchliff S, Elford H. "Opening a can of worms": GP and practice nurse barriers to talking about sexual health in primary care. Fam Pract. 2004;21:528–36.CrossRefPubMed
26.
Humphery S, Nazareth I. GPs' views on their management of sexual dysfunction. Fam Pract. 2001;18:516–8.CrossRefPubMed
27.
Muniyappa R, Norton M, Dunn ME, Banerji MA. Diabetes and female sexual dysfunction: moving beyond "benign neglect". Curr Diab Rep. 2005;5:230–6.CrossRefPubMed
28.
Andersen BL. How cancer affects sexual functioning. Oncology (Williston Park, NY). 1990;4:81–8.
29.
Mick J, Hughes M, Cohen MZ. Using the BETTER model to assess sexuality. Clin J Oncol Nurs. 2004;8:84–6.CrossRefPubMed
30.
Annon JS. The PLISSIT model: a proposed conceptual scheme for the behavioral treatment of sexual problems. J Sex Educ Ther. 1976;2:1–15.
31.
Rostamkhani F, Ozgoli G, Khoei EM, Jafari F, Majd HA. Effectiveness of the PLISSIT-based Counseling on sexual function of women. J Nurs Midwifery. 2012;22:76.
32.
Farnam F, Janghorbani M, Raisi F, Merghati-Khoei E. Compare the effectiveness of PLISSIT and sexual health models on Women's sexual problems in Tehran, Iran: a randomized controlled trial. J Sex Med. 2014;11:2679–89.CrossRefPubMed
33.
Rostamkhani F, Jafari F, Ozgoli G, Shakeri M. Addressing the sexual problems of Iranian women in a primary health care setting: a quasi-experimental study. Iran J Nurs Midwifery Res. 2015;20:139–46.PubMedPubMedCentral
34.
Ayaz S, Kubilay G. Effectiveness of the PLISSIT model for solving the sexual problems of patients with stoma. J Clin Nurs. 2009;18:89–98.CrossRefPubMed
35.
Chun N. [Effectiveness of PLISSIT model sexual program on female sexual function for women with gynecologic cancer]. J Korean Acad Nurs. 2011;41:471–80.
36.
Nho JH. [Effect of PLISSIT model sexual health enhancement program for women with gynecologic cancer and their husbands]. J Korean Acad Nurs. 2013;43:681–9.
37.
Alteneder RR, Hartzell D. Addressing couples' sexuality concerns during the childbearing period: Use of the PLISSIT model. J Obstet Gynecol Neonatal Nurs. 1997;26:651–8.CrossRefPubMed
38.
Cooley ME, Yeomans AC, Cobb SC. Sexual and reproductive issues for women with Hodgkin's disease II. Application of PLISSIT model. Canc Nurs. 1986;9:248–55.
39.
Seidl A, Bullough B, Haughey B, Scherer Y, Rhodes M, Brown G. Understanding the effects of a myocardial infarction on sexual functioning: a basis for sexual counseling. Rehabil Nurs. 1991;16:255–64.CrossRefPubMed
40.
41.
Harland R, Huws R. Sexual problems in diabetes and the role of psychological intervention. Sexual and Marital Therapy. 1997;12:147–57.CrossRef
42.
Whitehouse CR. Sexuality in the older female with diabetes mellitus–a review of the literature. Urol Nurs. 2009;29:11–8.PubMed
43.
Hatzichristou D, Rosen RC, Broderick G, Clayton A, Cuzin B, Derogatis L, et al. Clinical evaluation and management strategy for sexual dysfunction in men and women. J Sex Med. 2004;1:49–57.CrossRefPubMed
44.
Davis S, Taylor B. From PLISSIT to ex-PLISSIT. In Davis S (Ed) Rehabilitation: The use of theories and models in practice. Edinburgh: Elsevier; 2006;101-29.
45.
Annon JS. PLISSIT therapy. In Corsini RJ (Ed) Handbook of innovative psychotherapies. New York: Wiley & Sons; 1981;626-39.
46.
Van Weel-Baumgarten EM, Van Gelderen MG, Grundmeijer HGLM, Licht-Strunk E, Van Marwijk HWJ, Van Rijswijk HCAM, et al. NHG-Standaard Depressie (tweede herziening). Huisarts Wet. 2012;55:252–9.
47.
Leusink P, De Boer LJ, Vliet Vlieland CW, Rambharose VR, Sprengers AM, Mogendorff SW, et al. NHG-Standaard Erectiele disfunctie. Huisarts Wet. 2008;51:381–94.CrossRef
48.
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191–208.CrossRefPubMed
49.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–30.CrossRefPubMed
50.
Rosen RC, Cappelleri JC, Gendrano N. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002;14:226–44.CrossRefPubMed
51.
Giraldi A, Rellini A, Pfaus JG, Bitzer J, Laan E, Jannini EA, et al. Questionnaires for assessment of female sexual dysfunction: a review and proposal for a standardized screener. J Sex Med. 2011;8:2681–706.CrossRefPubMed
52.
ter Kuile MM, Brauer M, Laan E. The female sexual function index (FSFI) and the female sexual distress scale (FSDS): psychometric properties within a Dutch population. J Sex Marital Ther. 2006;32:289–304.CrossRefPubMed
53.
Johnson JA, Maddigan SL. Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes. Qual Life Res. 2004;13:449–56.CrossRefPubMed
54.
Jenkinson C, Layte R. Development and testing of the UK SF-12 (short form health survey). J Health Serv Res Policy. 1997;2:14–8.PubMed
55.
56.
57.
van Steenbergen-Weijenburg KM, de Vroege L, Ploeger RR, Brals JW, Vloedbeld MG, Veneman TF, et al. Validation of the PHQ-9 as a screening instrument for depression in diabetes patients in specialized outpatient clinics. BMC Health Serv Res. 2010;10:235.CrossRefPubMedPubMedCentral
58.
Zhang Y, Ting R, Lam M, Lam J, Nan H, Yeung R, et al. Measuring depressive symptoms using the patient health questionnaire-9 in Hong Kong Chinese subjects with type 2 diabetes. J Affect Disord. 2013;151:660–6.CrossRefPubMed
59.
Derogatis LR, Rosen R, Leiblum S, Burnett A, Heiman J. The female sexual distress scale (FSDS): initial validation of a standardized scale for assessment of sexually related personal distress in women. J Sex Marital Ther. 2002;28:317–30.CrossRefPubMed
60.
Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5:357–64.CrossRefPubMed
61.
Hajos TRS, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PHLM, Tack CJ, et al. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013;30:e63–9.CrossRefPubMed
62.
de Wit M, Pouwer F, Gemke RJBJ, Delemarre-van de Waal H, Snoek FJ. Validation of the WHO-5 Well-Being Index in adolescents with type 1 diabetes. Diabetes Care. 2007;30:2003–6.CrossRefPubMed
63.
Awata S, Bech P, Yoshida S, Hirai M, Suzuki S, Yamashita M, et al. Reliability and validity of the Japanese version of the World Health Organization-Five Well-Being Index in the context of detecting depression in diabetic patients. Psychiatry Clin Neurosci. 2007;61:112–9.CrossRefPubMed
64.
Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57:785–94.CrossRefPubMed
65.
Parker DR, Evangelou E, Eaton CB. Intraclass correlation coefficients for cluster randomized trials in primary care: the cholesterol education and research trial (CEART). Contemp Clin Trials. 2005;26:260–7.CrossRefPubMed
66.
67.
Calabro RS, De Luca R, Conti-Nibali V, Reitano S, Leo A, Bramanti P. Sexual dysfunction in male patients with multiple sclerosis: a need for counseling! Int J Neurosci. 2014;124:547–57.CrossRefPubMed
68.
de Vocht H, Hordern A, Notter J, van de Wiel H. Stepped Skills: A team approach towards communication about sexuality and intimacy in cancer and palliative care. Australas Med J. 2011;4:610–9.CrossRefPubMedPubMedCentral
69.
Fronek P, Booth S, Kendall M, Miller D, Geraghty T. The effectiveness of a sexuality training program for the interdisciplinary spinal cord injury rehabilitation team. Sex Disabil. 2005;23:51–63.CrossRef
Metadata
Title
Effectiveness of a PLISSIT model intervention in patients with type 2 diabetes mellitus in primary care: design of a cluster-randomised controlled trial
Authors
Anne Rutte
Patricia van Oppen
Giel Nijpels
Frank J. Snoek
Paul Enzlin
Peter Leusink
Petra J. M. Elders
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2015
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/s12875-015-0283-0

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