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Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis (ACT-IP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01981356
First received: November 4, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Psychotic Disorders
Behavioral: Acceptance and Commitment Therapy
Other: Treatment as Usual (TAU)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale (Overall & Gorham, 1962) [ Time Frame: Length of stay on inpatient unit for individual participants (expected 9 to 20 days) ] [ Designated as safety issue: No ]
    Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions).


Secondary Outcome Measures:
  • Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006) [ Time Frame: Length of stay on inpatient unit for individual participants (expected 9 to 20 days) ] [ Designated as safety issue: No ]
    Assesses changes in the frequency, believability, and associated distress of psychosis symptoms.

  • Acceptance and Action Questionnaire - II (Bond et al.., 2011) [ Time Frame: Length of stay on inpatient unit for individual participants (expected 9 to 20 days) ] [ Designated as safety issue: No ]
    Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance.

  • Positive and Negative Affect Scale (Watson et al., 1988) [ Time Frame: Length of stay on inpatient unit for individual participants (expected 9 to 20 days) ] [ Designated as safety issue: No ]
    Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty).

  • Cost of Stay [ Time Frame: Length of stay on inpatient unit for individual participants (expected 9 to 20 days) ] [ Designated as safety issue: No ]
    Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.

  • Barriers and Facilitators to implementation [ Time Frame: 12-month study period ] [ Designated as safety issue: No ]
    We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.

  • Experimental Treatment Feasibility [ Time Frame: 12-month study period ] [ Designated as safety issue: No ]
    Assessed by: (a) our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU; and (b) patient attendance at ACT sessions, which, corresponding to the minimum treatment dose, will be 3 out of 4 sessions, on average.

  • Experimental Treatment Acceptability [ Time Frame: 12-month study period ] [ Designated as safety issue: No ]
    Assessed by: (a) patient attendance of at least 3 out of 4 sessions on average; and (b) patient and ACT Facilitator reported treatment satisfaction and alliance. Measures used to assess treatment satisfaction (Client Satisfaction Questionnaire - 8 [CSQ-8]; Attkisson & Zwick, 1982) and alliance (Working Alliance Inventory [WAI]; Horvath & Greenberg, 1989) are psychometrically well-validated and recommended for use with patients with psychosis and/or in clinical trials.

  • Experimental Treatment Safety [ Time Frame: 12-month study period ] [ Designated as safety issue: No ]
    Assessed by the occurrence of zero adverse events attributable to ACT.


Estimated Enrollment: 92
Study Start Date: September 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acceptance and Commitment Therapy (ACT)
Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient�s admission to the inpatient unit. 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. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
Behavioral: Acceptance and Commitment Therapy

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.

Other Name: ACT
Active Comparator: Treatment as Usual (TAU)
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)
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981356

Contacts
Contact: Matthew T Boden, PhD (650) 493-5000 ext 27529 Matthew.Boden@va.gov
Contact: Marcel O Bonn-Miller, PhD (650) 493-5000 ext 27908 Marcel.Bonn-Miller@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: William Faustman, PhD    (650) 493-5000 ext 64950    William.Faustman@va.gov   
Contact: Sarah Yasmin, MD    (650) 493-5000 ext 68823    Sarah.Yasmin@va.gov   
Principal Investigator: Matthew Tyler Boden, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew Tyler Boden, PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01981356     History of Changes
Other Study ID Numbers: PPO 13-132, PPO 13-132-2
Study First Received: November 4, 2013
Last Updated: September 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Psychotic Disorders
Acceptance and Commitment Therapy
Inpatient psychiatry
Schizophrenia
Acute psychiatric disorder

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014