Schizophrenia
Conditions
Keywords
schizophrenia, social cognition, cognition, treatment, outcome
Brief summary
The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy. Objectives: This is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia. Research Design and Methodology: Approximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.
Interventions
BEHAVIORALSocial Cognition Interaction Training
manualized group therapy
BEHAVIORALWLC
wait-list control for 6 months, followed by the experimental group therapy
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of schizophrenia or schizoaffective disorder * Age between 18 and 65 * minimum of 30 days since discharge from last hospitalization * minimum of 30 days since last change in psychiatric medications * no housing changes in the past 30 days
Exclusion criteria
* current diagnosis of alcohol or substance abuse/dependence * history of brain trauma or neurological disease * mental retardation or developmental disability * auditory or visual impairment that would interfere with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Cognitive Measures | 6 months - baseline | change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Basic Cognitive Measures | 6 months - baseline | change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score |
Countries
United States
Participant flow
Pre-assignment details
Our initial plan had been to recruit and enroll 48 participants. 67 volunteers were assessed for eligibility. Of those, 9 did not meet inclusion criteria and 7 declined to participate after learning more about the study. Our initial plan had been to randomized 48 volunteers however due to concerns about potential drop-out, we recruited and randomized 51 participants.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 20-26 sessions of a manualized group treatment called social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual. | 25 |
| Waitlist Control 6 months of treatment as usual followed by Social Cognition Interaction Training | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | Waitlist Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 51 Participants |
| Age, Continuous | 49.96 years STANDARD_DEVIATION 9.15 | 45.56 years STANDARD_DEVIATION 10.97 | 47.80 years STANDARD_DEVIATION 10.23 |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 2 / 25 | 0 / 25 | 1 / 26 | 0 / 26 |
Outcome results
Primary
Social Cognitive Measures
change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement
Time frame: 6 months - baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Cognition Interaction Training | Social Cognitive Measures | 0.11 score on a scale | Standard Deviation 2 |
| Waitlist Control | Social Cognitive Measures | -1.68 score on a scale | Standard Deviation 2.57 |
Secondary
Basic Cognitive Measures
change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score
Time frame: 6 months - baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Cognition Interaction Training | Basic Cognitive Measures | 1.61 score on a scale | Standard Deviation 7.42 |
| Waitlist Control | Basic Cognitive Measures | 0.81 score on a scale | Standard Deviation 5.3 |