An Early Phase 1 interventional study of Acceptance and Commitment Therapy and Treatment as Usual (TAU) in Psychotic Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by VA Office of Research and Development · Early Phase 1, Interventional, and Treatment
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.
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.
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Inclusion criteria for the patient sample, used to establish feasibility, acceptability, safety, and efficacy of the experimental treatment, will be:
Inclusion criteria for the staff sample, used to identify barriers and facilitators to the implementation of the experimental treatment, will be
Exclusion Criteria:
None.
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
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)
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
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.
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).
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)
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).
Time frame: 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)
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).
Time frame: 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)
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.
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Cost of Stay
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.
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Barriers and Facilitators to Implementation
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.
Time frame: 8-month study period
Experimental Treatment Feasibility
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.
Time frame: 8-month study period
Experimental Treatment Acceptability
Assessed by patient attendance of at least 3 out of 4 sessions on average.
Time frame: 8-month study period
Experimental Treatment Safety
Assessed by the occurrence of zero adverse events attributable to ACT.
Time frame: 8-month study period
Experimental Treatment Acceptability
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).
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Experimental Treatment Acceptability
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).
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
We reviewed charts for 429 admissions over 8 months; 67 patients were approached because they potentially met study criteria
| Milestone | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Started | 12 | 6 |
| Completed | 5 | 4 |
| Not completed | 7 | 2 |
| Withdrew: Lost to follow-up | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Protocol violation | 2 | 0 |
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).
| percentage of total possible change | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Brief Psychiatric Rating Scale (Overall & Gorham, 1962) | -8.0 ± 13.8 | -11.6 ± 5.8 |
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).
| percentage of total possible change | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Frequency | -14.6 ± 17.2 | -22.2 ± 25.5 |
| Believability | -15.3 ± 15.3 | -35.2 ± 61.4 |
| Distress | -12.5 ± 14.6 | -34.7 ± 48.5 |
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).
| percentage of total possible change | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Acceptance and Action Questionnaire - II (Bond et al.., 2011) | 14.5 ± 29.6 | 19.8 ± 33.9 |
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.
| percentage of total possible change | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Positive Affect | 16.5 ± 37.0 | 18.1 ± 32.5 |
| Negative Affect | -15.5 ± 30.9 | -27.5 ± 40.6 |
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.
| Dollars | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Cost of Stay | 43,728.75 ± 26,190.96 | 25,415.00 ± 19,086.88 |
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.
| Participants providing data | Inpatient Psychiatry Unit Staff Members |
|---|---|
| Barriers and Facilitators to Implementation | 4 |
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.
| participants | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Experimental Treatment Feasibility | 10 | 6 |
Assessed by patient attendance of at least 3 out of 4 sessions on average.
| sessions | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Experimental Treatment Acceptability | 4.0 ± 0.0 | 3.5 ± 1.0 |
Assessed by the occurrence of zero adverse events attributable to ACT.
| adverse events | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Experimental Treatment Safety | 0 | 0 |
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).
| units on a scale | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Experimental Treatment Acceptability | 2.9 ± 0.3 | 3.3 ± 0.4 |
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).
| units on a scale | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) |
|---|---|---|
| Experimental Treatment Acceptability | 4.7 ± 1.0 | 5.3 ± 1.1 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | — | 0/12 (0%) | 0/12 (0%) |
| Treatment as Usual (TAU) | — | 0/6 (0%) | 0/6 (0%) |
Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.
| Age, Continuous(years) | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mean | 52.4 ± 16.2 | 55.8 ± 17.7 | 53.7 ± 16.3 |
| Sex: Female, Male(Participants) | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 10 | 6 | 16 |
| Race/Ethnicity, Customized(participants) | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| White/Caucasian | 4 | 2 | 6 |
| Hispanic or Latino/a | 2 | 2 | 4 |
| Black or African American | 2 | 2 | 4 |
| Asian or Asian American | 1 | 0 | 1 |
| Not reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Acceptance and Commitment Therapy (ACT) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| United States | 10 | 6 | 16 |
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