Clinical trial NCT01981356: Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
Official title: Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Psychotic Disorders
Keywords: Psychotic Disorders
Acceptance and Commitment Therapy
Inpatient psychiatry
Schizophrenia
Acute psychiatric disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-11-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health Administration (VHA) inpatient services for psychosis and tailoring them to support recovery. The proposed pilot study will explore whether Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable, safe, and effective adjunct for the inpatient treatment of Veterans with psychosis at a single VHA site. Additionally, an evaluation of barriers and facilitators to future implementation will be conducted. If promising, the data gained from the proposed study will support future evaluation, implementation and dissemination efforts that have the potential to improve inpatient treatment for psychosis and recovery, and thus, the lives of Veterans, while reducing costs for VHA.

Detailed description: Within the Veterans Health Administration (VHA) in fiscal year 2011, patients with psychotic disorders represented approximately 4% of the total population, and received approximately 14% of VHA's total expenditures (Blow et al., 2011). Patients with psychosis receive substantial, repeated, and costly inpatient treatment, and this is often the only chance to provide treatment due to gaps in mental health service utilization (Blow et al., 2011; McCarthy et al., 2007). Thus, there is an urgent need for enhancing the efficacy and effectiveness of VHA inpatient services and tailoring them to better support recovery.

Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based adjunct to inpatient treatment for psychosis, is an excellent candidate for investigations within VHA inpatient settings. ACT for psychosis is considered an empirically supported treatment by the American Psychological Association (APA, 2012; Chambless et al., 1998). A consistent body of research has demonstrated the clinical effectiveness of ACT for treatment of psychosis, including well-designed randomized clinical trials of ACT on inpatient settings (Bach \& Hayes, 2000; Gaudiano \& Herbert, 2006). ACT is effective when provided in a flexible format of three to four sessions, and for patients with a range of chronic and severe psychotic and comorbid mental disorders.

This proposed pilot study aims to explore ACT as an adjunct to inpatient treatment as usual (TAU) for psychosis among VHA patients at one VHA inpatient psychiatry unit. The project will use an effectiveness/ implementation Hybrid Type 1 design that incorporates a pilot RCT and semi-formative evaluation of barriers and facilitators to future implementation. Participants will be 80 VHA patients with current psychotic symptoms (hallucinations and/or delusions) related to a psychotic or mood disorder who are admitted to an inpatient psychiatry unit VA Palo Alto Health Care System (VAPAHCS). Participants will be randomly assigned to receive either TAU (n = 40), or TAU with plus 4-sessions of ACT (n = 40) individually provided during their stay on the inpatient unit. Aim 1 is to investigate the feasibility, acceptability, and safety of the treatment for VHA patients, as indexed by: (a) the ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in the study and be randomized to ACT + TAU or TAU; (b) patient attendance of 3 ACT individual sessions (out of 4 possible) on average; (c) patient and ACT Facilitator (provider of the intervention), reported ACT treatment satisfaction and alliance; and (d) the occurrence of zero serious adverse events attributable to the ACT treatment. Aim 2 is to investigate treatment effects of ACT on patient functioning (i.e., acceptance), symptomatology, distress, and affect. Aim 3 is to obtain data from participating patients and unit staff regarding system-, clinician- and patient-level barriers and facilitators to implementing staff-delivered ACT services for psychosis at the participating VHA inpatient setting, including: (a) barriers that limit patients, staff, and site participation in ACT and how to address them; (b) provider and patient perceptions about why ACT is successful at achieving better outcomes; (c) site specific and general barriers to implementation of ACT and how to address them; and (d) perceived value of and how to sustain ACT in the absence of a funded project.

This project is the first step in exploring a potentially sustainable and effective intervention that will improve inpatient psychosis treatment and recovery, and hence, the lives of VHA patients with psychosis, while reducing costs for VHA. If promising, study findings will support a HSR\&D Investigator Initiated Research (IIR) Merit grant application that will propose to assess the effectiveness and cost of implementing the ACT intervention, and potential barriers and facilitators for implementation efforts at multiple VHA inpatient psychiatric units. The aims of this project align with the HSR\&D research priority area of improving mental and behavioral interventions for individuals with serious mental illness by refining recovery-oriented treatment approaches related to evidence-based programs.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the patient sample, used to establish feasibility, acceptability, safety, and efficacy of the experimental treatment, will be:

* hospitalized with current psychosis symptoms (hallucinations and/or delusions);
* DSM-IV-TR (APA, 2000) diagnosis of a psychotic disorder (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified) or a mood disorder with psychotic features (major depression, bipolar I disorder) that requires hospitalization;
* ability to provide informed consent ;
* conversational in English; and
* patient stay on the unit estimated in advance to be greater than one week.

Inclusion criteria for the staff sample, used to identify barriers and facilitators to the implementation of the experimental treatment, will be

* ability to provide informed consent and
* conversational in English.

Exclusion Criteria:

None.

Primary outcomes:
measure: Brief Psychiatric Rating Scale (Overall & Gorham, 1962)
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Secondary outcomes:
measure: Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
measure: Acceptance and Action Questionnaire - II (Bond et al.., 2011)
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
measure: Positive and Negative Affect Scale (Watson et al., 1988)
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
measure: Cost of Stay
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
measure: Barriers and Facilitators to Implementation
timeFrame: 8-month study period
measure: Experimental Treatment Feasibility
timeFrame: 8-month study period
measure: Experimental Treatment Acceptability
timeFrame: 8-month study period
measure: Experimental Treatment Safety
timeFrame: 8-month study period
measure: Experimental Treatment Acceptability
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
measure: Experimental Treatment Acceptability
timeFrame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Matthew T Boden, PhD
role: PRINCIPAL_INVESTIGATOR
References: