ASCI: Social Cognition Intervention

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01267019
• Collaborator: (none)
• Enrollment: 153
• Location: 1
• Arms: 3
• Duration (Months): 58
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Veterans with schizophrenia and schizoaffective disorder experience high levels of disability and poor community outcome, and these poor functional outcomes constitute a major public health concern. The treatment of schizophrenia spectrum disorders has shifted fundamentally from a focus on symptom reduction to a focus on recovery and improving aspects of functioning. Needed improvements in community outcome for patients with these disorders will not occur simply through better control of clinical symptoms. Instead, it is necessary to find new treatments that address the key determinants of poor functional outcome, including social cognition. Both basic (non-social) cognition and social cognition are considered key determinants of functional outcome for schizophrenia and schizoaffective disorder. Basic cognition includes the domains of: learning and memory, vigilance / attention, speed of processing, reasoning and problem solving, and working memory. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors of others. As part of the investigators' previous Merit grant, they have developed a training program for social cognition and are in the process of validating it. Initial results suggest that the program improves performance on measures of social cognition and functional capacity.

In this study, the investigators will evaluate whether adding an in vivo component (training activities that occur in the community) to the current social cognition intervention facilitates generalization of training effects to community outcome and subjective satisfaction. Outcome measures of social cognition and functional capacity will be examined during the 12 week training program, and durability of benefits will be assessed at a 3-month follow up. Generalization to community functioning and subjective satisfaction will be assessed at the end of training and at the 3-month follow up. The investigators will enroll 105 patients across the 5 years of the study with random assignment to training group (social cognition intervention with in vivo exercises, social cognition intervention without in vivo exercises and control). Subjects will receive assessments at baseline, 6 weeks (mid-point), completion of training (12 weeks), and the 3-month follow up.

Condition or Disease	Intervention/Treatment	Phase
Psychosis	Behavioral: social cognitive training with in vivo augmentation; Behavioral: social cognitive training; Behavioral: non-social skills training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Augmenting Social Cognitive Intervention for Veterans With Schizophrenia
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: vivo augmentation social cognitive training with in vivo augmentation	Behavioral: social cognitive training with in vivo augmentation; 24 sessions of social cognitive training plus 6 sessions of in vivo exercises
Active Comparator: Arm 2: social cognitive social cognitive training	Behavioral: social cognitive training; 30 sessions of social cognitive training without in vivo exercises
Active Comparator: Arm 3: non-social skills non-social skills training	Behavioral: non-social skills training; 30 sessions of skills training that has no specific social content

Outcome Measures

Primary Outcome Measures

1. Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [baseline, 6 weeks, 12 weeks, and 3 months.]

   A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

Secondary Outcome Measures

1. The Awareness of Social Inference Test (TASIT) [baseline, 6 weeks, 12 weeks, and 3 months.]

   A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

2. Profile of Nonverbal Sensitivity (PONS) [baseline, 6 weeks, 12 weeks, and 3 months.]

   A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All patients must be diagnosed with Schizophrenia, Schizoaffective Disorder, or Psychosis not otherwise specified (NOS) according to Diagnosis and Statistical Manual (DSM-IV) criteria. In addition, the subjects will meet the following criteria:

• Between 18 and 60 years of age

• Estimated premorbid intelligence quota > 70 (based on reading ability)

• Understand spoken English sufficiently to comprehend testing procedures

• Clinically stable (e.g., no inpatient hospitalization in the 8 weeks prior to enrollment, no significant changes in medication in the 4 weeks prior to enrollment, and none anticipated for the 3 months of participation)

• In sufficient health to be able to walk outdoors unaided for at least 15 minutes.

Exclusion Criteria:

• No clinically significant neurological disease as determined by medical history

• No history of serious head injury (e.g., loss of consciousness longer than 1 hour)

• No physical, cognitive, or language impairment of such severity as to adversely affect the validity of data

• No evidence of drug or alcohol dependence in the past six months, and not intoxicated at time of testing based on urine toxicology screen and saliva alcohol test strip. Subjects who test positive will not be disqualified but instead will be asked to return for testing on a different day. However, subjects who test positive on 3 consecutive occasions will be disqualified from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01267019
• Other Study ID Numbers: MHBB-004-10S
• First Posted: Dec 24, 2010
• Last Update Posted: Mar 15, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by VA Office of Research and Development: social cognition; training intervention
• Additional relevant MeSH terms: Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Arm 1: Vivo Augmentation	Arm 2: Social Cognitive	Arm 3: Non-social Skills
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises	social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises	non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content
Period Title: Overall Study
STARTED	47	53	53
COMPLETED	41	47	47
NOT COMPLETED	6	6	6

Baseline Characteristics

Arm/Group Title	Arm 1: Vivo Augmentation	Arm 2: Social Cognitive	Arm 3: Non-social Skills	Total
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises	social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises	non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content	Total of all reporting groups
Overall Participants	41	47	47	135
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (11.3)	48.8 (9.1)	46.7 (10.2)	47.3 (10.2)
Sex: Female, Male (Count of Participants)
Female	9 22%	21 44.7%	11 23.4%	41 30.4%
Male	32 78%	26 55.3%	36 76.6%	94 69.6%

Outcome Measures

1. Primary Outcome

Title	Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Description	A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Time Frame	baseline, 6 weeks, 12 weeks, and 3 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Vivo Augmentation	Arm 2: Social Cognitive	Arm 3: Non-social Skills
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises	social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises	non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content
Measure Participants	41	47	47
Baseline	87.30 (1.12)	87.30 (1.12)	88.46 (1.58)
6 weeks	89.23 (1.16)	89.23 (1.16)	87.61 (1.62)
12 weeks	87.84 (1.76)	89.78 (1.36)	87.68 (1.62)
3 months	86.78 (1.87)	90.42 (1.46)	86.51 (1.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Vivo Augmentation, Arm 2: Social Cognitive, Arm 3: Non-social Skills
	Comments	This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< .05
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	The Awareness of Social Inference Test (TASIT)
Description	A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Time Frame	baseline, 6 weeks, 12 weeks, and 3 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Vivo Augmentation	Arm 2: Social Cognitive	Arm 3: Non-social Skills
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises	social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises	non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content
Measure Participants	41	47	47
Baseline	44.67 (.82)	44.67 (.82)	46.79 (.93)
6 weeks	45.45 (.77)	45.45 (.77)	46.22 (1.04)
12 weeks	46.00 (1.24)	46.91 (1.05)	46.81 (1.02)
3 months	45.83 (1.4)	46.91 (1.05)	46.73 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Vivo Augmentation, Arm 2: Social Cognitive, Arm 3: Non-social Skills
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Profile of Nonverbal Sensitivity (PONS)
Description	A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110. Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study.
Time Frame	baseline, 6 weeks, 12 weeks, and 3 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Vivo Augmentation	Arm 2: Social Cognitive	Arm 3: Non-social Skills
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises	social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises	non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content
Measure Participants	41	47	47
baseline	75.76 (.91)	75.76 (.91)	77.41 (1.16)
6 weeks	78.90 (.79)	78.90 (.79)	79.24 (1.11)
12 weeks	76.83 (1.52)	78.60 (1.04)	79.89 (1.16)
3 months	76.72 (1.94)	79.28 (1.28)	80.56 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Vivo Augmentation, Arm 2: Social Cognitive, Arm 3: Non-social Skills
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Arm/Group Title	Arm 1: Vivo Augmentation		Arm 2: Social Cognitive		Arm 3: Non-social Skills
Arm/Group Description	social cognitive training with in vivo augmentation social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises		social cognitive training social cognitive training: 30 sessions of social cognitive training without in vivo exercises		non-social skills training non-social skills training: 30 sessions of skills training that has no specific social content
All Cause Mortality
	Arm 1: Vivo Augmentation		Arm 2: Social Cognitive		Arm 3: Non-social Skills
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Vivo Augmentation		Arm 2: Social Cognitive		Arm 3: Non-social Skills
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/47 (10.6%)		4/53 (7.5%)		3/53 (5.7%)
Cardiac disorders
cardiac arrest	0/47 (0%)	0	1/53 (1.9%)	1	0/53 (0%)	0
Metabolism and nutrition disorders
diabetic incident	0/47 (0%)	0	0/53 (0%)	0	1/53 (1.9%)	1
Psychiatric disorders
acute exacerbation of symptoms	5/47 (10.6%)	5	3/53 (5.7%)	3	2/53 (3.8%)	2
Other (Not Including Serious) Adverse Events
	Arm 1: Vivo Augmentation		Arm 2: Social Cognitive		Arm 3: Non-social Skills
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/53 (0%)		0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.