Bipolar Disorder, Psychotic Disorders, Schizophrenia, Substance-Related Disorders
Conditions
Keywords
Schizophrenia / disorders w psychotic features, Substance-related disorders, Community Mental Health Services, Case Management, Health Education
Brief summary
Surveys suggest that up to 80% of veterans with a persistent mental illness have a co-occurring substance use disorder. Substance abuse among this population is problematic and often results in poor engagement in treatment and thus, frequent hospitalizations and an unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to outpatient care did not attend their initial screening appointment and another 30% dropped out within six weeks. To assist with the transition from inpatient to outpatient care, we previously developed an eight-week augmentation intervention entitled, Time-Limited Case Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2) Critical Time Intervention Case Management along with 3) Peer Support with the goal of assisting individuals with the transition from inpatient to outpatient care.
Detailed description
This study involved a randomized attention controlled trial of 102 individuals recruited on the inpatient psychiatry service at the New Jersey VA with a substance abuse disorder and a severe and persistent mental illness. Subjects were randomly assigned to one of two conditions: 1) treatment-as-usual in inpatient and outpatient services plus 8 weeks of Time Limited Care-Coordination (TLC), a brief linkage augmentation intervention or 2) treatment-as-usual along with 8 weeks of matched attention in the form of health education sessions (TAU+A). The data analytic plan included descriptive and advanced statistical analysis. Objective # 1: To determine whether those in TLC have better attendance in inpatient sessions compared to those receiving Treatment-As-Usual Plus Attention (TAU+A). Objective # 2: To determine whether those in TLC have better attendance in outpatient sessions compared to those receiving Treatment-As-Usual Plus Attention (TAU+A). Objective # 3: To determine whether TLC, compared to Treatment-As-Usual Plus Attention (TAU+A) reduces rehospitalizations and has an effect on the use of the Emergency Room use. Objective # 4: To determine whether TLC achieves a reduction in drug usage and related problems as compared to those receiving TAU+A. A total of 102 veterans were randomly assigned to one of two conditions: (1) Time Limited Care-Coordination (TLC), an eight-week co-occurring disorders intervention or (2) Treatment As Usual + Matched Attention (TAU+A) control condition in the form of health education sessions. However, both groups also received treatment as usual in inpatient and outpatient settings.
Interventions
BEHAVIORALTime limited case management
This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
BEHAVIORALHealth Education
This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients over 18 years old. 2. Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder. 3. Patients seeking outpatient treatment for the above disorders from the VA. 4. Physically mobile 5. Agree to take public transportation if they do not have other private sources.
Exclusion criteria
1. Patients who only have either a mental health problem, or a substance abuse problem, but not both. 2. Patients who do not have a residence where they can stay upon discharge from the hospital. 3. Patients who are not sufficiently medically or psychiatrically stable to participate in residential or outpatient treatment. Those patients could be re-evaluated for the study once stabilized. 4. Patients exclusively engaged in methadone maintenance programs. 5. Patients who represent a serious suicide risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement | 8 weeks | Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Engaged | 8 weeks | Number of days veteran was involved with the program, from initial consent to last day of contact |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Time Limited Case Management (TLC) This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.
Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition. | 40 |
| Arm 2 - Health Education This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.
Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging. | 26 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 21 |
Baseline characteristics
| Characteristic | Arm 1 - Time Limited Case Management (TLC) | Total | Arm 2 - Health Education |
|---|---|---|---|
| Age, Customized 40 - 49 years | 17 participants | 25 participants | 8 participants |
| Age, Customized 50 and older | 19 participants | 33 participants | 14 participants |
| Age, Customized less than 40 years | 4 participants | 8 participants | 4 participants |
| Region of Enrollment United States | 40 participants | 66 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 38 Participants | 64 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 26 |
| serious Total, serious adverse events | 0 / 40 | 0 / 26 |
Outcome results
Primary
Treatment Engagement
Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Treatment Engagement | Inpatient treatment sessions | 4.2 number of treatment sessions attended | Standard Deviation 3.7 |
| Arm 1 | Treatment Engagement | Outpatient treatment sessions | 7.2 number of treatment sessions attended | Standard Deviation 7.4 |
| Arm 2 | Treatment Engagement | Inpatient treatment sessions | 1.4 number of treatment sessions attended | Standard Deviation 2.2 |
| Arm 2 | Treatment Engagement | Outpatient treatment sessions | 1.5 number of treatment sessions attended | Standard Deviation 5.2 |
p-value: <0.001Chi-squared
Secondary
Number of Days Engaged
Number of days veteran was involved with the program, from initial consent to last day of contact
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Number of Days Engaged | 37.3 Days engaged in program | Standard Deviation 21.3 |
| Arm 2 | Number of Days Engaged | 28.9 Days engaged in program | Standard Deviation 25.1 |
p-value: 0.152Chi-squared