Early Phase 1
N=18
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01981356 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Brief Psychiatric Rating Scale (Overall & Gorham, 1962) — -8.0; -11.6 percentage of total possible change
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Acceptance and Commitment Therapy (Behavioral); Treatment as Usual (TAU) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Psychiatric Rating Scale (Overall & Gorham, 1962) |
-8.0; -11.6 | — |
| SECONDARY Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006) |
-14.6; -22.2; -15.3; -35.2; -12.5; -34.7 | — |
| SECONDARY Acceptance and Action Questionnaire - II (Bond et al.., 2011) |
14.5; 19.8 | — |
| SECONDARY Positive and Negative Affect Scale (Watson et al., 1988) |
16.5; 18.1; -15.5; -27.5 | — |
| SECONDARY Cost of Stay |
43,728.75; 25,415.00 | — |
| SECONDARY Barriers and Facilitators to Implementation |
4 | — |
| SECONDARY Experimental Treatment Feasibility |
10; 6 | — |
| SECONDARY Experimental Treatment Acceptability |
4.7; 5.3 | — |
| SECONDARY Experimental Treatment Safety |
0; 0 | — |
| SECONDARY Experimental Treatment Acceptability |
4.7; 5.3 | — |
| SECONDARY Experimental Treatment Acceptability |
4.7; 5.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01981356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.