title: Effectiveness of a PLISSIT model intervention in patients with type 2 diabetes mellitus in primary care: design of a cluster-randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch Trial Registry NTR4807 .
authors.affiliation: Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. a.rutte@vumc.nl.|VU University Medical Centre, Department of General Practice and Elderly Care Medicine, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. a.rutte@vumc.nl.
authors.forename: Anne
authors.initials: A
authors.lastname: Rutte
authors.affiliation: Department of Psychiatry, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. p.vanoppen@ggzingeest.nl.
authors.forename: Patricia
authors.initials: P
authors.lastname: van Oppen
authors.affiliation: Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. g.nijpels@vumc.nl.
authors.forename: Giel
authors.initials: G
authors.lastname: Nijpels
authors.affiliation: Department of Medical Psychology, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. fj.snoek@vumc.nl.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Snoek
authors.affiliation: Department of Neurosciences, Institute for Family and Sexuality Studies, KU Leuven, Leuven, Belgium. paul.enzlin@uzleuven.be.|Centre for Clinical Sexology and Sex Therapy, UPC KU Leuven, Leuven, Belgium. paul.enzlin@uzleuven.be.
authors.forename: Paul
authors.initials: P
authors.lastname: Enzlin
authors.affiliation: Department of Sexology, Groene Hart Hospital, Gouda, The Netherlands. leusinkp@knmg.nl.
authors.forename: Peter
authors.initials: P
authors.lastname: Leusink
authors.affiliation: Department of General Practice and Elderly Care Medicine, EMGO Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. p.elders@vumc.nl.
authors.forename: Petra J M
authors.initials: PJ
authors.lastname: Elders
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011580:Psychological Techniques; D011788:Quality of Life; D012731:Sex Counseling / Q000379:methods*; D012735:Sexual Dysfunction, Physiological / Q000209:etiology / Q000523:psychology / Q000628:therapy; D020018:Sexual Dysfunctions, Psychological / Q000209:etiology / Q000503:physiopathology / Q000628:therapy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome