Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills, Social, Training
Brief summary
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.
Detailed description
This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.
Interventions
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
BEHAVIORALGoal Focused Supportive Contact (GFSC)
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 45 years of age and older * DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder * Fluent in speaking, reading, and writing English * Physically and psychiatrically stable enough to undergo various assessments in this study
Exclusion criteria
Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent Living Skills Survey (ILSS) | baseline, mid-treatment, end of treatment, mid-follow up, and follow up | The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | baseline, mid-treatment, end of treatment, mid follow-up, and followup | The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms. |
| Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | baseline, mid treatment, end of treatment, mid follow-up, and follow up | The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13). |
| Comprehensive Module Test (CMT) | baseline, mid-treatment, end of treatment, mid-follow up, and follow up | The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition. |
| Beck Depression Inventory-II (BDI-II) | baseline, mid-treatment, end of treatment, mid follow-up, and follow-up | The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression. |
| Beck Anxiety Inventory (BAI) | baseline, mid-treatment, end of treatment, mid follow-up, and follow up | The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety. |
| The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | baseline, mid-treatment, end of treatment, mid follow-up, and follow-up | The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22). |
Countries
United States
Participant flow
Recruitment details
Participants included 79 middle age and older community dwelling Veteran and non-veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, and fluency in English. Exclusion criteria: prior exposure to CBT during the previous five years.
Pre-assignment details
Baseline data were collected before randomization. N=116 participants enrolled in the study and N=79 started. Total of 37 excluded for reasons: n=20 lost interest; n=6 wrong diagnosis, n=3 not psychiatrically stable; n=3 not medically stable, and n=5 lost contact/moved.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Social Skills Training (CBSST) Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months. | 31 |
| Goal Focused Supportive Contact (GFSC) Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months. | 33 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Baseline and one other ILSS required | 10 | 5 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Social Skills Training (CBSST) | Goal Focused Supportive Contact (GFSC) | Total |
|---|---|---|---|
| Age, Customized Between ages 45 to 78 | 31 participants | 33 participants | 64 participants |
| Region of Enrollment United States | 31 participants | 33 participants | 64 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 38 |
| serious Total, serious adverse events | 4 / 41 | 11 / 38 |
Outcome results
Primary
Independent Living Skills Survey (ILSS)
The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.
Time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Independent Living Skills Survey (ILSS) | Baseline | 0.66 units on a scale | Standard Deviation 0.09 |
| Cognitive Behavioral Social Skills Training | Independent Living Skills Survey (ILSS) | Mid-Followup (13.5 months) | 0.68 units on a scale | Standard Deviation 0.07 |
| Cognitive Behavioral Social Skills Training | Independent Living Skills Survey (ILSS) | End of treatment (9 months) | 0.68 units on a scale | Standard Deviation 0.07 |
| Cognitive Behavioral Social Skills Training | Independent Living Skills Survey (ILSS) | Follow Up (9 months) | 0.71 units on a scale | Standard Deviation 0.07 |
| Cognitive Behavioral Social Skills Training | Independent Living Skills Survey (ILSS) | Mid-treatment (4.5 months) | 0.68 units on a scale | Standard Deviation 0.1 |
| Goal Focused Supportive Contact | Independent Living Skills Survey (ILSS) | Follow Up (9 months) | 0.68 units on a scale | Standard Deviation 0.13 |
| Goal Focused Supportive Contact | Independent Living Skills Survey (ILSS) | Mid-treatment (4.5 months) | 0.71 units on a scale | Standard Deviation 0.1 |
| Goal Focused Supportive Contact | Independent Living Skills Survey (ILSS) | Baseline | 0.70 units on a scale | Standard Deviation 0.11 |
| Goal Focused Supportive Contact | Independent Living Skills Survey (ILSS) | End of treatment (9 months) | 0.71 units on a scale | Standard Deviation 0.12 |
| Goal Focused Supportive Contact | Independent Living Skills Survey (ILSS) | Mid-Followup (13.5 months) | 0.72 units on a scale | Standard Deviation 0.12 |
Secondary
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Beck Anxiety Inventory (BAI) | Mid-treatment (4.5 months) | 14.2 units on a scale | Standard Deviation 12.3 |
| Cognitive Behavioral Social Skills Training | Beck Anxiety Inventory (BAI) | Mid-Followup (13.5 months) | 12.3 units on a scale | Standard Deviation 12.2 |
| Cognitive Behavioral Social Skills Training | Beck Anxiety Inventory (BAI) | End of treatment (9 months) | 15.7 units on a scale | Standard Deviation 14.2 |
| Cognitive Behavioral Social Skills Training | Beck Anxiety Inventory (BAI) | Follow Up (9 months) | 11.5 units on a scale | Standard Deviation 10.1 |
| Cognitive Behavioral Social Skills Training | Beck Anxiety Inventory (BAI) | Baseline | 16.4 units on a scale | Standard Deviation 12.7 |
| Goal Focused Supportive Contact | Beck Anxiety Inventory (BAI) | Follow Up (9 months) | 10.4 units on a scale | Standard Deviation 11 |
| Goal Focused Supportive Contact | Beck Anxiety Inventory (BAI) | Baseline | 14.5 units on a scale | Standard Deviation 12.1 |
| Goal Focused Supportive Contact | Beck Anxiety Inventory (BAI) | Mid-treatment (4.5 months) | 12.4 units on a scale | Standard Deviation 12.1 |
| Goal Focused Supportive Contact | Beck Anxiety Inventory (BAI) | End of treatment (9 months) | 10.6 units on a scale | Standard Deviation 10.1 |
| Goal Focused Supportive Contact | Beck Anxiety Inventory (BAI) | Mid-Followup (13.5 months) | 10.5 units on a scale | Standard Deviation 11.4 |
Secondary
Beck Depression Inventory-II (BDI-II)
The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Beck Depression Inventory-II (BDI-II) | Baseline | 16.3 units on a scale | Standard Deviation 9.8 |
| Cognitive Behavioral Social Skills Training | Beck Depression Inventory-II (BDI-II) | Mid-treatment (4.5 months) | 17.2 units on a scale | Standard Deviation 12.3 |
| Cognitive Behavioral Social Skills Training | Beck Depression Inventory-II (BDI-II) | End of treatment (9 months) | 15.0 units on a scale | Standard Deviation 12.6 |
| Cognitive Behavioral Social Skills Training | Beck Depression Inventory-II (BDI-II) | Mid-Followup (13.5 months) | 9.1 units on a scale | Standard Deviation 7.9 |
| Goal Focused Supportive Contact | Beck Depression Inventory-II (BDI-II) | Mid-Followup (13.5 months) | 12.9 units on a scale | Standard Deviation 12.7 |
| Goal Focused Supportive Contact | Beck Depression Inventory-II (BDI-II) | Baseline | 16.4 units on a scale | Standard Deviation 13.5 |
| Goal Focused Supportive Contact | Beck Depression Inventory-II (BDI-II) | End of treatment (9 months) | 14.3 units on a scale | Standard Deviation 14 |
| Goal Focused Supportive Contact | Beck Depression Inventory-II (BDI-II) | Mid-treatment (4.5 months) | 13.8 units on a scale | Standard Deviation 11.2 |
Secondary
Comprehensive Module Test (CMT)
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Comprehensive Module Test (CMT) | End of treatment (9 months) | 12.0 units on a scale | Standard Deviation 7.1 |
| Cognitive Behavioral Social Skills Training | Comprehensive Module Test (CMT) | Follow Up (9 months) | 11.2 units on a scale | Standard Deviation 7.2 |
| Cognitive Behavioral Social Skills Training | Comprehensive Module Test (CMT) | Baseline | 6.2 units on a scale | Standard Deviation 3.6 |
| Cognitive Behavioral Social Skills Training | Comprehensive Module Test (CMT) | Mid-treatment (4.5 months) | 8.6 units on a scale | Standard Deviation 5.6 |
| Cognitive Behavioral Social Skills Training | Comprehensive Module Test (CMT) | Mid-Followup (13.5 months) | 10.5 units on a scale | Standard Deviation 4.8 |
| Goal Focused Supportive Contact | Comprehensive Module Test (CMT) | Mid-Followup (13.5 months) | 6.3 units on a scale | Standard Deviation 4.3 |
| Goal Focused Supportive Contact | Comprehensive Module Test (CMT) | End of treatment (9 months) | 5.5 units on a scale | Standard Deviation 4.1 |
| Goal Focused Supportive Contact | Comprehensive Module Test (CMT) | Mid-treatment (4.5 months) | 6.2 units on a scale | Standard Deviation 5.1 |
| Goal Focused Supportive Contact | Comprehensive Module Test (CMT) | Follow Up (9 months) | 5.8 units on a scale | Standard Deviation 3.8 |
| Goal Focused Supportive Contact | Comprehensive Module Test (CMT) | Baseline | 4.8 units on a scale | Standard Deviation 3.3 |
Secondary
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and followup
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Follow Up (9 months) | 15.7 units on a scale | Standard Deviation 5.5 |
| Cognitive Behavioral Social Skills Training | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Mid-treatment (4.5 months) | 17.4 units on a scale | Standard Deviation 6.4 |
| Cognitive Behavioral Social Skills Training | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Baseline | 18.3 units on a scale | Standard Deviation 8.1 |
| Cognitive Behavioral Social Skills Training | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | End of treatment (9 months) | 15.5 units on a scale | Standard Deviation 5.8 |
| Cognitive Behavioral Social Skills Training | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Mid-Followup (13.5 months) | 15.8 units on a scale | Standard Deviation 6.8 |
| Goal Focused Supportive Contact | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | End of treatment (9 months) | 16.1 units on a scale | Standard Deviation 5.3 |
| Goal Focused Supportive Contact | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Mid-Followup (13.5 months) | 18.0 units on a scale | Standard Deviation 6.7 |
| Goal Focused Supportive Contact | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Follow Up (9 months) | 18.5 units on a scale | Standard Deviation 8.1 |
| Goal Focused Supportive Contact | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Baseline | 17.8 units on a scale | Standard Deviation 6.3 |
| Goal Focused Supportive Contact | Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Mid-treatment (4.5 months) | 15.5 units on a scale | Standard Deviation 5.8 |
Secondary
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).
Time frame: baseline, mid treatment, end of treatment, mid follow-up, and follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Mid-treatment (4.5 months) | 1.72 units on a scale | Standard Deviation 1.13 |
| Cognitive Behavioral Social Skills Training | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Mid-Followup (13.5 months) | 1.71 units on a scale | Standard Deviation 1 |
| Cognitive Behavioral Social Skills Training | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | End of treatment (9 months) | 1.21 units on a scale | Standard Deviation 1.12 |
| Cognitive Behavioral Social Skills Training | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Follow Up (9 months) | 1.62 units on a scale | Standard Deviation 1.06 |
| Cognitive Behavioral Social Skills Training | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Baseline | 1.63 units on a scale | Standard Deviation 1.37 |
| Goal Focused Supportive Contact | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Follow Up (9 months) | 1.83 units on a scale | Standard Deviation 1.3 |
| Goal Focused Supportive Contact | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Baseline | 1.79 units on a scale | Standard Deviation 1.09 |
| Goal Focused Supportive Contact | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Mid-treatment (4.5 months) | 1.48 units on a scale | Standard Deviation 0.87 |
| Goal Focused Supportive Contact | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | End of treatment (9 months) | 1.38 units on a scale | Standard Deviation 1.04 |
| Goal Focused Supportive Contact | Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression | Mid-Followup (13.5 months) | 1.62 units on a scale | Standard Deviation 1.31 |
Secondary
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Social Skills Training | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Mid-treatment (4.5 months) | 2.09 units on a scale | Standard Deviation 1.35 |
| Cognitive Behavioral Social Skills Training | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Mid-Followup (13.5 months) | 1.53 units on a scale | Standard Deviation 1.03 |
| Cognitive Behavioral Social Skills Training | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | End of treatment (9 months) | 1.90 units on a scale | Standard Deviation 1.3 |
| Cognitive Behavioral Social Skills Training | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Follow Up (9 months) | 1.72 units on a scale | Standard Deviation 1.02 |
| Cognitive Behavioral Social Skills Training | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Baseline | 2.02 units on a scale | Standard Deviation 1.17 |
| Goal Focused Supportive Contact | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Follow Up (9 months) | 1.93 units on a scale | Standard Deviation 1.44 |
| Goal Focused Supportive Contact | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Baseline | 2.46 units on a scale | Standard Deviation 1.15 |
| Goal Focused Supportive Contact | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Mid-treatment (4.5 months) | 2.15 units on a scale | Standard Deviation 1.18 |
| Goal Focused Supportive Contact | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | End of treatment (9 months) | 1.83 units on a scale | Standard Deviation 1.31 |
| Goal Focused Supportive Contact | The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation | Mid-Followup (13.5 months) | 1.92 units on a scale | Standard Deviation 1.43 |