title: A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia.
abstract: OBJECTIVE
  Epidemiological evidence suggests an association between psychological factors and functional dyspepsia (FD). Yet few randomized controlled trials (RCTs) of psychological interventions have been conducted for FD. We conducted an RCT to evaluate the efficacy of psychotherapy among chronic FD.
  
  
  METHODS
  One hundred fifty-eight consecutive patients with FD were randomized to medical therapy plus psychotherapy consisted in 8 group and 2 individual sessions focused on teaching techniques for coping with FD (intensive treatment (IT); n=76) or medical therapy alone (conventional treatment (CT); n=82). Patients completed validated self-reported questionnaires before and after the 10-week treatment and 6 months later. Linear mixed-effects models were used, in intention-to-treat analysis.
  
  
  RESULTS
  At the end of treatment period, statistically significant improvements were observed for IT compared with CT for dyspepsia-related quality of life (DRQoL). DRQoL mean changes of 6.09 and 3.54 were obtained in IT and CT patients, respectively (p=<0.0001); and SS mean changes of 11.55 and 4.57 were obtained in IT and CT patients, respectively (p=0.0013). Those improvements, measured by minimum clinically important difference (MCID), were clinically significant (DRQoL: 77% of the IT patients exceeded the MCID vs. the 45% of the CT; SS: 75% vs. 48%). Six months after treatment, those statistically significant improvements persisted for DRQoL (p=0.0067) and for SS (p=0.0405). Clinical improvements persisted for SS (63% vs. 41%).
  
  
  CONCLUSIONS
  These findings suggest that adding psychotherapy to standard medical therapy improves short-term outcomes in patients with FD and may have long-term effects as well. The cost-effectiveness of intensive therapy needs to be evaluated. Registration number and name of trial registry: NCT01802710.
authors: Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: miren.orivecalzada@osakidetza.net.
authors: M
authors: M
authors: Orive
authors: Department of Applied Mathematics, Statistics and Operational Research, University of the Basque Country UPV/EHU, Leioa, Spain. Electronic address: irantzu.barrio@ehu.es.
authors: I
authors: I
authors: Barrio
authors: Digestive Service, Basurto University Hospital, Bilbao, Bizkaia, Spain. Electronic address: victormanuel.orivecura@osakidetza.net.
authors: V M
authors: VM
authors: Orive
authors: Psychology Department of Personality, Assessment and Treatment, University of Deusto, Bilbao, Bizkaia, Spain. Electronic address: b.matella@fice.deusto.es.
authors: B
authors: B
authors: Matellanes
authors: Department of Psychiatry, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain. Electronic address: jesusangel.padiernaacero@osakidetza.net.
authors: J A
authors: JA
authors: Padierna
authors: Digestive Service, Galdakao-Usansolo Hospital, Bilbao, Bizkaia, Spain. Electronic address: joseluis.cabriadanuno@osakidetza.net.
authors: J
authors: J
authors: Cabriada
authors: Digestive Service, Galdakao-Usansolo Hospital, Bilbao, Bizkaia, Spain. Electronic address: aitor.orivecalzada@osakidetza.net.
authors: A
authors: A
authors: Orive
authors: Research Unit, Basurto University Hospital, Bilbao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: antonio.escobarmartinez@osakidetza.net.
authors: A
authors: A
authors: Escobar
authors: Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: josemaria.quintanalopez@osakidetza.net.
authors: J M
authors: JM
authors: Quintana
mesh_terms: D000223:Adaptation, Psychological; D003131:Combined Modality Therapy / Q000379:methods; D004415:Dyspepsia / Q000503:physiopathology / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011613:Psychotherapy / Q000379:methods; D011615:Psychotherapy, Group; D011788:Quality of Life; D057566:Self Report; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Dyspepsia related quality of life; Functional dyspepsia; Psychotherapy; Randomized clinical trial; Responsiveness