- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981356
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis (ACT-IP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Acceptance and Commitment Therapy (ACT)
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.
|
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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Psychiatric Rating Scale (Overall & Gorham, 1962)
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Assesses changes in the frequency, believability, and associated distress of psychosis symptoms.
Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores.
Subscale 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 to lowest 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 to highest possible value on scale from baseline to follow-up.
Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).
|
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)
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance.
All scale items were averaged to obtain a total scale score.
Total 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.
Increases in percentage change are considered better outcomes (i.e., increased acceptance).
|
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)
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty).
Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores.
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 (5) 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 (5) possible value on scale from baseline to follow-up.
Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.
|
Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Cost of Stay
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
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.
|
Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Barriers and Facilitators to Implementation
Time Frame: 8-month study period
|
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.
|
8-month study period
|
Experimental Treatment Feasibility
Time Frame: 8-month study period
|
Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.
|
8-month study period
|
Experimental Treatment Acceptability
Time Frame: 8-month study period
|
Assessed by patient attendance of at least 3 out of 4 sessions on average.
|
8-month study period
|
Experimental Treatment Safety
Time Frame: 8-month study period
|
Assessed by the occurrence of zero adverse events attributable to ACT.
|
8-month study period
|
Experimental Treatment Acceptability
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson & Zwick, 1982; range 0 to 5, higher scores indicate better outcome).
|
Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Experimental Treatment Acceptability
Time Frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; range 1 to 7, higher score indicated better outcome).
|
Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthew T Boden, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 13-132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
VA Office of Research and DevelopmentRecruitingMI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMIHomelessness | Schizophrenia Spectrum Disorders | Psychotic Mood Disorders | Psychotic Affective Disorders | Ill-Housed PersonsUnited States
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
University Hospital, CaenRecruiting
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
University of California, San DiegoActive, not recruitingSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
Boston Medical CenterNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterCompletedPsychotic Disorders | Psychosis | Psychotic EpisodeUnited States
Clinical Trials on Acceptance and Commitment Therapy
-
Francisco Garcia TorresUniversidad de CórdobaRecruiting
-
Anne Roche, MACompletedQuality of Life | AgingUnited States
-
University of CoimbraUnknown
-
Universiti Sains MalaysiaRecruitingBreast Cancer FemaleMalaysia
-
University of CyprusNot yet recruitingDepression | Anxiety Disorders | Post Traumatic Stress Disorder
-
University of Alabama at BirminghamWithdrawn
-
Nova Scotia Health AuthorityCompleted
-
University of TromsoThe Royal Norwegian Ministry of HealthActive, not recruiting
-
VA Office of Research and DevelopmentCompletedChronic Pain | Mild Traumatic Brain Injury | Distress-based PsychopathologyUnited States
-
University of Alabama at BirminghamCompletedPsychological DistressUnited States