Trial Outcomes & Findings for Efficacy of Social Cognition Training in Schizophrenia (NCT NCT00587561)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

6 months - baseline

Results posted on

2025-10-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Intervention Social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual.	Waitlist Control Treatment as usual (0 - 6 months), then crossed-over to social cognition interaction training.
Overall Study STARTED	25	26
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual.	Waitlist Control Treatment as usual (0 - 6 months), then crossed-over to social cognition interaction training.
Overall Study Lost to Follow-up	6	4

Baseline Characteristics

Efficacy of Social Cognition Training in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=25 Participants 20-26 sessions of a manualized group treatment called social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual.	Waitlist Control n=26 Participants 6 months of treatment as usual followed by Social Cognition Interaction Training	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.56 years STANDARD_DEVIATION 10.97 • n=5 Participants	49.96 years STANDARD_DEVIATION 9.15 • n=7 Participants	47.80 years STANDARD_DEVIATION 10.23 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	26 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Social Cognition Interaction Training n=19 Participants social cognition training	Waitlist Control n=22 Participants wait list control
Social Cognitive Measures	0.11 score on a scale Standard Deviation 2.00	-1.68 score on a scale Standard Deviation 2.57

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Social Cognition Interaction Training n=18 Participants social cognition training	Waitlist Control n=22 Participants wait list control
Basic Cognitive Measures	1.61 score on a scale Standard Deviation 7.42	0.81 score on a scale Standard Deviation 5.30

Adverse Events

Intervention Group: Social Cognition Interaction Training

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group: Treatment As Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group, Treatment As Usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group, Social Cognition Interaction Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention Group: Social Cognition Interaction Training n=25 participants at risk First period of Intervention Group, social cognition interaction training from 0 -6 months.	Intervention Group: Treatment As Usual n=25 participants at risk Second period of Intervention Group, treatment as usual after 6 months.	Waitlist Control Group, Treatment As Usual n=26 participants at risk First period of Waitlist Control Group, treatment as usual from 0 - 6 months.	Waitlist Control Group, Social Cognition Interaction Training n=26 participants at risk Second period of Waitlist Control Group, social cognition interaction training after 6 months.
Psychiatric disorders hospitalization	4.0% 1/25 • Number of events 1	0.00% 0/25	0.00% 0/26	0.00% 0/26
Psychiatric disorders hospitalization for suicidal ideation	4.0% 1/25 • Number of events 1	0.00% 0/25	3.8% 1/26 • Number of events 2	0.00% 0/26

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanna Fiszdon

VA Connecticut Healthcare System

Phone: 2039325711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place