Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis

NCT01981356 | Completed Early Phase 1 Results

• 1 other identifier: PPO 13-132
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Keywords

Psychotic Disorders; Acceptance and Commitment Therapy; Inpatient psychiatry; Schizophrenia; Acute psychiatric disorder

Outcome Measures

Primary Outcomes (1)

• Brief Psychiatric Rating Scale (Overall & Gorham, 1962)

  Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).

  Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).

Secondary Outcomes (10)

• Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)

  Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).

• Acceptance and Action Questionnaire - II (Bond et al.., 2011)

  Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).

• Positive and Negative Affect Scale (Watson et al., 1988)

  Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).

• Cost of Stay

  Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).

• Barriers and Facilitators to Implementation

  8-month study period

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions. The treatment protocol is adapted from and virtually identical to that presented in Gaudiano and Herbert (2006). Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Participants in the ACT condition will also receive treatment as usual.

Behavioral: Acceptance and Commitment Therapy

Treatment as Usual (TAU)

ACTIVE COMPARATOR

TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.

Other: Treatment as Usual (TAU)

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

The goal of ACT is to help the patient increase psychological flexibility, a core component of mental health and well-being. ACT teaches clients to be mindfully aware but nonreactive to delusions/ hallucinations and to increase willingness to experience associated distressing emotions while simultaneously engaging in meaningful behavioral actions. Patients expand their repertoire of behaviors to live according to their values and to pursue valued goals, thereby increasing adaptive functioning and quality of life.

Also known as: ACT

Acceptance and Commitment Therapy (ACT)

Treatment as Usual (TAU) OTHER

All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Patient recruitment was hindered by patient characteristics, and inherent difficulties in conducting research with psychiatry inpatients. These issues do not address whether ACT is a beneficial inpatient treatment for psychosis.

Results Point of Contact

• Title: Matthew Boden, Ph.d.
• Organization: Center for Innovation to Implementation, VA Palo Alto HCS

Matthew.Boden@va.gov

650-493-5000

Study Officials

• Matthew T Boden, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 14, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)