title: Feasibility and challenges of inpatient psychotherapy for psychosis: lessons learned from a veterans health administration pilot randomized controlled trial.
abstract: BACKGROUND
  In large health care systems, decision regarding broad implementation of psychotherapies for inpatients with psychosis require substantial evidence regarding effectiveness and feasibility for implementation. It is important to recognize challenges in conducting research to inform such decisions, including difficulties in obtaining consent from and engaging inpatients with psychosis in research. We set out to conduct a feasibility and effectiveness Hybrid Type I pilot randomized controlled trial of acceptance and commitment therapy (ACT) and a semi-formative evaluation of barriers and facilitators to implementation.
  
  
  RESULTS
  We developed a training protocol and refined an ACT treatment manual for inpatient treatment of psychosis for use at the Veterans Health Administration. While our findings on feasibility were mixed, we obtained supportive evidence of the acceptability and safety of ACT. Identified strengths of ACT included a focus on achievement of valued goals rather than symptoms. Weaknesses included that symptoms may limit patient's understanding of ACT. Facilitators included building trust and multi-stage informed consent processes. Barriers included restrictive eligibility criteria, rigid use of a manualized protocol, and individual therapy format. Conclusions are limited by our randomization of only 18 patient participants (with nine completing all aspects of the study) out of 80 planned.
  
  
  CONCLUSIONS
  Future studies should include (1) multi-stage informed consent processes to build trust and alleviate patient fears, (2) relaxation of restrictions associated with obtaining efficacy/effectiveness data, and (3) use of Hybrid Type II and III designs.
authors.affiliation: Center for Innovation to Implementation, VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA, 94025, USA. Matthew.Boden@va.gov.
authors.forename: Matthew Tyler
authors.initials: MT
authors.lastname: Boden
authors.affiliation: Department of Psychiatry and Human Behavior, Brown Medical School, Providence, RI, USA.|Psychosocial Research Program, Butler Hospital, Providence, RI, USA.
authors.forename: Brandon A
authors.initials: BA
authors.lastname: Gaudiano
authors.affiliation: National Center for PTSD, VA Palo Alto Healthcare System, Palo Alto, CA, USA.|University of California, Berkeley, CA, USA.
authors.forename: Robyn D
authors.initials: RD
authors.lastname: Walser
authors.affiliation: Center for Innovation to Implementation, VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA, 94025, USA.|Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Timko
authors.affiliation: Palo Alto Division, VA Palo Alto Healthcare System, Palo Alto, CA, USA.|Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Faustman
authors.affiliation: Palo Alto Division, VA Palo Alto Healthcare System, Palo Alto, CA, USA.|Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Yasmin
authors.affiliation: Center for Innovation to Implementation, VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA, 94025, USA.|Department of Sociology, Stanford University, Stanford, CA, USA.|Center for Primary Care and Outcomes Research, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Ruth C
authors.initials: RC
authors.lastname: Cronkite
authors.affiliation: Center for Innovation to Implementation, VA Palo Alto Health Care System, 795 Willow Road (152-MPD), Menlo Park, CA, 94025, USA.|National Center for PTSD, VA Palo Alto Healthcare System, Palo Alto, CA, USA.|Center of Excellence in Substance Abuse Treatment and Education, Philadelphia VA Medical Center, Philadelphia, PA, USA.
authors.forename: Marcel O
authors.initials: MO
authors.lastname: Bonn-Miller
authors.affiliation: Serious Mental Illness Treatment Resource and Evaluation Center, VA Office of Mental Health Operations, Ann Arbor, MI, USA.|Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: McCarthy
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D007297:Inpatients / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology* / Q000706:statistics & numerical data; D010865:Pilot Projects; D011613:Psychotherapy / Q000941:ethics / Q000458:organization & administration*; D011618:Psychotic Disorders / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D014481:United States; D014493:United States Department of Veterans Affairs; D014728:Veterans; D058014:Veterans Health / Q000941:ethics
keywords: Acceptance and commitment therapy; Feasibility; Hybrid type I; Psychosis; Randomized controlled trial