Psychotic Disorders, Veterans
Conditions
Keywords
Psychosis, Serious Mental Illness, Veterans, Hearing Voices
Brief summary
Veterans with Serious Mental Illness (SMI) struggle with social integration - participation in work, housing, and citizenship - due to symptoms, stigma, and psychosocial challenges. Despite considerable VA efforts to provide mental health care to Veterans with SMI, programs that promote social integration are lacking. Veterans with SMI are at especially high risk for poor social integration and suicidal ideation during the COVID-19 pandemic. This project addresses this need with a group-based, peer specialist (PS) co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV targets Veterans with SMI who experience psychosis, a group particularly in need of support with social integration. Virtual VVV groups are co-led by VA mental health clinicians (MHCs) and PSs via online video conference. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of SMI: hallucinations, delusions, and social isolation. This intervention has the potential to create and foster a supportive community that improves the social integration of participants by reducing their distress and self-stigma, and increasing self-efficacy.
Detailed description
This is a single arm study of feasibility and acceptability of the adapted manual and protocol we have developed in preparation for a larger efficacy trial.
Interventions
BEHAVIORALVeteran Voices and Visions
Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single arm trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* DSM 5 diagnoses of: * schizophrenia * schizoaffective disorder * bipolar with psychosis * depression with psychosis * PTSD with psychosis * unspecified psychosis
Exclusion criteria
* Substance-induced psychosis, * clinically significant neurological disease, * history of serious head injury with loss of consciousness \> 1 hour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Psychotic Symptoms Rating Scale (PSYRATS-AH) | 12 weeks after the initiation of the intervention | PSYRATS-AH is an 11-item scale which assesses the frequency, duration, severity, loudness, location, negative content, and controllability of voices, intensity of distress, and beliefs about origin of voices and disruptiveness. Minimum score is 0, maximum 44. Any decrease in overall score is indicative of decreased distress. |
| Role Functioning Scale Total Score | 12 weeks after the initiation of the intervention | The Role Functioning Scale (RFS) is a broad global integration index across the 4 domains: work, independent living, and family relationships and immediate social network relationships. Each domain ranges from 1 (worst) to 7 (best), for a total score range of minimum 4, maximum 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beliefs About Voices Questionnaire-R Omnipotence Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The omnipotence subscale measures the amount of omnipotence the subjects attributes to their voice. Minimum score is 0, maximum is 18, higher score indicates greater omnipotence. |
| Beliefs About Voices Questionnaire-R Malevolence Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The malevolence subscale measures the amount of malevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater malevolence. |
| Beliefs About Voices Questionnaire-R Benevolence Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The benevolence subscale measures the amount of benevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater benevolence. |
| Beliefs About Voices Questionnaire-R Resistance Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The resistance subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum is 18, higher score indicates greater resistance and less engagement. |
| Beliefs About Voices Questionnaire-R Emotional Resistance Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional resistance subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 12, higher score indicates greater resistance and less engagement. |
| Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral resistance subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 15, higher score indicates greater resistance and less engagement. |
| Beliefs About Voices Questionnaire-R Engagement Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The engagement subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum 27, higher score indicates greater engagement. |
| Beliefs About Voices Questionnaire - R Emotional Engagement Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional engagement subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 15, higher score indicates greater engagement. |
| Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale | 12 weeks | The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral engagement subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 12, Higher score indicates greater engagement. |
| Peters Delusion Inventory Count | 12 weeks | The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 21. Higher score indicates worse outcome. |
| Peters Delusion Inventory Distress Subscale | 12 weeks | The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 60. Higher score indicates worse outcome. The distress subscale measures the amount of cumulative distress associated with all reported delusions. |
| Brief Psychiatric Rating Scale Global Score | 12 weeks | Assesses for psychiatric symptoms-specifically the positive/negative symptom assess subscale scores and suicidal ideation. Minimum score is 24, maximum is 168. Higher score indicates worse outcome. |
| Questionnaire on the Process of Recovery | 12 weeks | The Questionnaire on the Process of Recovery (QPR) is an instrument co-developed by service users and re-searchers about recovery from psychosis with 15 items measuring connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Minimum score is 0, maximum is 60. Higher score indicates better outcome. |
| Generalized Self-Efficacy Scale | 12 weeks | Generalized Self-Efficacy Scale is a 10-item measure of self-efficacy that has been shown to be valid and reliable and has been used with schizophrenia. Range, 10-40. Higher score indicates better outcome. |
| Internalized Stigma of Mental Illness | 12 weeks | The Internalized Stigma of Mental Illness scale is a 29-item measure of internalized stigma with five subscales (alienation, stereotype endorsement, discrimination, experience, social withdrawal, and stigma resistance). It has been used with schizophrenia and is reliable (a = .90) and valid. Range, 1-4, as all item scores are averaged. Higher score indicates worse outcome. |
| UCLA Loneliness Scale | 12 weeks | UCLA Loneliness Scale, a 20-item scale measuring subjective experience of loneliness, is considered the gold standard measure of perceived social isolation and is highly reliable (a = .89-.94) and valid. It has been used with SSD. Range, 20-80. Higher score indicates worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIppolytos A Kalofonos, MD PhD MPH
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Participant flow
Recruitment details
36 signed consent forms. However, 8 of these dropped out of the study before completing the per-intervention assessment either because they changed their mind (3) or because the study team was unable to contact them (5). 28 completed the pre-intervention assessment but 3 of these left the study prior to being assigned to the intervention groups. One of these was found to have been ineligible, and two of these could not be contacted by the study team. Therefore 25 participants entered the study.
Pre-assignment details
Once participants signed consent forms, they had to complete the pre-intervention assessment and then be assigned to a intervention group. Some participants left the study during this process, which could take several weeks.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 14.8 |
| Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale | 2.5 units on a scale STANDARD_DEVIATION 3 |
| Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale | 7.8 units on a scale STANDARD_DEVIATION 5.2 |
| Beliefs About Voices Questionnaire-R Benevolence Subscale | 5.6 units on a scale STANDARD_DEVIATION 6 |
| Beliefs About Voices Questionnaire - R Emotional Engagement Subscale | 3.6 units on a scale STANDARD_DEVIATION 3.9 |
| Beliefs About Voices Questionnaire-R Emotional Resistance Subscale | 5.9 units on a scale STANDARD_DEVIATION 3.8 |
| Beliefs About Voices Questionnaire-R Engagement Subscale | 6.2 units on a scale STANDARD_DEVIATION 6.5 |
| Beliefs About Voices Questionnaire-R Malevolence Subscale | 5.6 units on a scale STANDARD_DEVIATION 5.9 |
| Beliefs About Voices Questionnaire-R Omnipotence Subscale | 7.3 units on a scale STANDARD_DEVIATION 4.2 |
| Beliefs About Voices Questionnaire-R Resistance Subscale | 13.8 units on a scale STANDARD_DEVIATION 8.4 |
| Brief Psychiatric Rating Scale Global Score | 43.1 units on a scale STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Generalized Self-efficacy Scale | 31.1 units on a scale STANDARD_DEVIATION 6.4 |
| Internalized Stigma of Mental Illness | 2.2 units on a scale STANDARD_DEVIATION 0.5 |
| Peters Delusion Inventory Count | 6.5 units on a scale STANDARD_DEVIATION 4.5 |
| Peters Delusion Inventory Distress Subscale | 2.8 units on a scale STANDARD_DEVIATION 1.3 |
| Questionnaire on the Process of Recovery | 41.4 units on a scale STANDARD_DEVIATION 9.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Role Functioning Scale Total Score Change | 17.4 units on a scale STANDARD_DEVIATION 5.1 |
| Sex/Gender, Customized female | 3 Participants |
| Sex/Gender, Customized male | 21 Participants |
| Sex/Gender, Customized nonbinary | 1 Participants |
| The Psychotic Symptoms Rating Scale (PSYRATS-AH) | 21.0 units on a scale STANDARD_DEVIATION 10.7 |
| UCLA Loneliness Scale | 49 units on a scale STANDARD_DEVIATION 13.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
None listed