Major Depression, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Mental Illness, Schizophrenia, Education, Family member treatment, Active psychoses
Brief summary
The purpose of this study is to learn how to help veterans play a stronger role in shaping their mental health care. Specifically we want to see if we can help veterans improve their mental health treatment by helping them decide if they want to involve family in their mental health treatment, and if so, how. The study will compare a family member provider program to an enhanced treatment as usual approach in achieving these goals.
Detailed description
Previous research demonstrates that when families are active participants in the clinical care of persons with SMI, veterans experience improved outcomes, including treatment retention, vocational services participation, and empowerment. Numerous controlled trials show that when family involvement achieves the level of intensity and family psychoeducation (FPE), relapse rates are cut in half, and treatment adherence, clinical symptoms, and patient functioning are improved. However, despite these demonstrated benefits, rates of family involvement in the VA are unacceptably low. Even minimal family-clinician contact occurs for only one third of VA SMI patients, a lower rate than in non-VA systems of care. Therefore, it is not surprising that FPE, an intensive form of family-clinician contact, is almost never offered in the VA. In fact, a national VA survey conducted within the last three years indicated that 0% of VAs offer FPE programs conforming to EBP guidelines. Our previous experience further suggests that these deficits in care are due to combinations of provider, patient, and family factors, and that the VA presents specific challenges to implementing existing model programs, including FPE. We therefore believe it is necessary to approach the challenge of increasing family involvement in a step-wise fashion, first by engaging families in the processes of care, before trying to enlist them in more intensive programs such as FPE. Further, family engagement would likely be most effective if it builds on a foundation that empowers consumers to make informed choices regarding the involvement of relatives in care. Our group has developed and piloted a new, family-engagement approach that is gradual, patient-centered, recovery-based, and can address various barriers to improving care. It is manualized and thus replicable. The proposed study will implement and further evaluate this intervention, the brief Family Member Provider Outreach (FMPO).
Interventions
BEHAVIORALFamily Member Provider Outreach
Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
BEHAVIORALEnhanced treatment as usual (e-TAU)
Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Sponsors
University of Maryland, Baltimore County
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years * Diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC){{646}} (schizophrenic disorders (295.0-295.9), affective psychoses (296.1, 296.4-296.8) and other psychotic diagnoses (297.0-298.9)) or diagnosis of Major Depression with psychotic features (296.xx) * Decisional capacity to provide informed consent * At least two outpatient visits within last six months * At least monthly face-to-face contact for one hour or more with a patient-identified family member or caregiver * Assessment by the treating therapist or psychiatrist that the patient is clinically stable enough to participate in the program. Family Member/Caregiver Inclusion Criteria * Age 18-80 years * Decisional capacity to provide informed consent * Permission from veteran to be contacted
Exclusion criteria
* Patients whose families have attended the FPE group within the last six months * Patients whose families have had at least monthly clinician contact in the last six months * Patients who are currently homeless * Patients who participated in the FMPO pilot. Family Member/Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family-Clinician Contact (Including Contact With FMPO Clinician) | Within 6 months of intervention | Chart review looking at the any clinician contact with veteran's family members |
| Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Within 6 months of intervention | Chart review looking at the any clinician contact with veteran's family members |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumer's Recovery Rating - MHRM Total Score | Within 6 months of intervention | We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery. |
| Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score | Within 6 month of the intervention | We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery. |
Countries
United States
Participant flow
Pre-assignment details
We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
Participants by arm
| Arm | Count |
|---|---|
| FMPO Condition Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.
Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission. | 117 |
| Enhanced Treatment as Usual (e-TAU) Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.
Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team. | 115 |
| Total | 232 |
Baseline characteristics
| Characteristic | FMPO Condition | Enhanced Treatment as Usual (e-TAU) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 114 Participants | 109 Participants | 223 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.4 | 51.2 years STANDARD_DEVIATION 8.7 | 51.5 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 117 participants | 115 participants | 232 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 97 Participants | 98 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 115 |
| serious Total, serious adverse events | 2 / 117 | 1 / 115 |
Outcome results
Primary
Family-Clinician Contact (Including Contact With FMPO Clinician)
Chart review looking at the any clinician contact with veteran's family members
Time frame: Within 6 months of intervention
Population: We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMPO Condition | Family-Clinician Contact (Including Contact With FMPO Clinician) | Pre Test (Baseline) | .4 Number of Interactions | Standard Deviation 2 |
| FMPO Condition | Family-Clinician Contact (Including Contact With FMPO Clinician) | Post Test (Within 6 months of the intervention) | 1.6 Number of Interactions | Standard Deviation 2.3 |
| Enhanced Treatment as Usual (e-TAU) | Family-Clinician Contact (Including Contact With FMPO Clinician) | Pre Test (Baseline) | .3 Number of Interactions | Standard Deviation 0.9 |
| Enhanced Treatment as Usual (e-TAU) | Family-Clinician Contact (Including Contact With FMPO Clinician) | Post Test (Within 6 months of the intervention) | .3 Number of Interactions | Standard Deviation 1 |
Primary
Family-Clinician Contact (Not Including Notes From FMPO Clinicians)
Chart review looking at the any clinician contact with veteran's family members
Time frame: Within 6 months of intervention
Population: We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMPO Condition | Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Pre Test (Baseline) | .4 Number of Interactions | Standard Deviation 2 |
| FMPO Condition | Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Post Test (Within 6 months of the intervention) | .5 Number of Interactions | Standard Deviation 2 |
| Enhanced Treatment as Usual (e-TAU) | Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Pre Test (Baseline) | .3 Number of Interactions | Standard Deviation 0.9 |
| Enhanced Treatment as Usual (e-TAU) | Family-Clinician Contact (Not Including Notes From FMPO Clinicians) | Post Test (Within 6 months of the intervention) | .3 Number of Interactions | Standard Deviation 1 |
Secondary
Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score
We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.
Time frame: Within 6 month of the intervention
Population: We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMPO Condition | Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score | Pre Test (Baseline) | 10.6 units on a scale | Standard Deviation 2.5 |
| FMPO Condition | Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score | Post Test (Within 6 months of the intervention) | 11.4 units on a scale | Standard Deviation 2.6 |
| Enhanced Treatment as Usual (e-TAU) | Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score | Pre Test (Baseline) | 11.4 units on a scale | Standard Deviation 2.5 |
| Enhanced Treatment as Usual (e-TAU) | Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score | Post Test (Within 6 months of the intervention) | 11.3 units on a scale | Standard Deviation 2.3 |
Secondary
Consumer's Recovery Rating - MHRM Total Score
We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.
Time frame: Within 6 months of intervention
Population: We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMPO Condition | Consumer's Recovery Rating - MHRM Total Score | Pre Test (Baseline) | 75.6 Units on a Scale | Standard Deviation 17.3 |
| FMPO Condition | Consumer's Recovery Rating - MHRM Total Score | Post Test (Within 6 months of the intervention) | 80.2 Units on a Scale | Standard Deviation 18.7 |
| Enhanced Treatment as Usual (e-TAU) | Consumer's Recovery Rating - MHRM Total Score | Pre Test (Baseline) | 77.0 Units on a Scale | Standard Deviation 19.1 |
| Enhanced Treatment as Usual (e-TAU) | Consumer's Recovery Rating - MHRM Total Score | Post Test (Within 6 months of the intervention) | 79.9 Units on a Scale | Standard Deviation 20.4 |