Trial Outcomes & Findings for RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness (NCT NCT02380885)
NCT ID: NCT02380885
Last Updated: 2025-03-06
Results Overview
A widely used measure of emotion perception and is indexed by the total number of correctly identified emotions out of nineteen pictured faces (higher number indicates better emotion identification).
COMPLETED
NA
158 participants
This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
2025-03-06
Participant Flow
A total of 158 participants participated in the study (158 participants were randomized into three groups). Data were collected between the years 2014 and 2018 from four psychiatric rehabilitation agencies.
Participant milestones
| Measure |
SCIT
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
Treatment as Usual
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
58
|
38
|
|
Overall Study
COMPLETED
|
23
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
39
|
38
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
Baseline characteristics by cohort
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
38.9 years
STANDARD_DEVIATION 11 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
39.94 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex/Gender, Customized
male
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Sex/Gender, Customized
female
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
The Face Emotion Identification Task (FEIT)
|
12.83 units on a scale
n=5 Participants
|
12.42 units on a scale
n=7 Participants
|
11.55 units on a scale
n=5 Participants
|
12.29 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)
A widely used measure of emotion perception and is indexed by the total number of correctly identified emotions out of nineteen pictured faces (higher number indicates better emotion identification).
Outcome measures
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
|---|---|---|---|
|
The Face Emotion Identification Task (FEIT)
PRE group intervention
|
12.83 score on a scale
Standard Deviation 2.86
|
12.47 score on a scale
Standard Deviation 3.71
|
11.55 score on a scale
Standard Deviation 3.20
|
|
The Face Emotion Identification Task (FEIT)
POST group intervention
|
13.65 score on a scale
Standard Deviation 2.71
|
13.65 score on a scale
Standard Deviation 3.45
|
12.00 score on a scale
Standard Deviation 3.73
|
PRIMARY outcome
Timeframe: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)
The Faux Pas Task is a social cognition assessment tool that measures the ability to detect and understand social faux pas - situations where someone says something they shouldn't have said because they didn't know or realize certain information. Faux-Pas task in its Hebrew version (Shamay-Tsoory, Tomer, Berger, Goldsher, \& Aharon-Peretz, 2005) was used to assess TOM. It consist of 10 stories in which a faux pas has occurred and 10 control stories. It assesses emotional and cognitive attributions and the score for each story ranged between 0 to 7. After each story the participants are asked six questions regarding the recognition of faux-pas (understanding the mental state of speaker and listener, understanding the emotional state of the listener). The total score ranges from 0 to 70, when higher scores indicate better ability to detect social mistakes.
Outcome measures
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
|---|---|---|---|
|
Faux-Pas Task
PRE group intervention
|
30.79 score on a scale
Standard Deviation 8.19
|
30.11 score on a scale
Standard Deviation 6.84
|
27.95 score on a scale
Standard Deviation 8.11
|
|
Faux-Pas Task
POST group intervention
|
34.41 score on a scale
Standard Deviation 5.51
|
31.89 score on a scale
Standard Deviation 7.98
|
29.20 score on a scale
Standard Deviation 8.51
|
PRIMARY outcome
Timeframe: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)
The AIHQ is a measure of attributional style for situations with negative outcomes and ambiguous causality. Participants are asked to read each of five vignettes, to imagine that the scenario is happening to her or him, and to write down the reason why the other person acted the way he did toward the participant. Two independent raters subsequently code this written response for the purpose of computing a "hostility bias." The participant then rates the degree to which he or she thinks the other person performed the action on purpose, how angry this action would make the participant feel, and how much the participant would blame the other person. Four scales that are calculated: Hostility Bias, Blame Score, Aggression Bias, Intentionality Bias (each is a 5-point Likert scale) . In the total scores, each scale can be range from 0 (min) to 25 (max), with higher scores indicating greater attribution of hostile intent, blame, or aggressive response tendencies.
Outcome measures
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
|---|---|---|---|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Hostility bias - pre group intervention
|
10.93 score on a scale
Standard Deviation 3.50
|
12.63 score on a scale
Standard Deviation 4.20
|
11.64 score on a scale
Standard Deviation 3.70
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Hostility bias - post group intervention
|
10.19 score on a scale
Standard Deviation 2.34
|
11.64 score on a scale
Standard Deviation 4.50
|
12.06 score on a scale
Standard Deviation 3.61
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Intentionality score - pre
|
12.49 score on a scale
Standard Deviation 3.31
|
12.58 score on a scale
Standard Deviation 4.66
|
12.42 score on a scale
Standard Deviation 3.76
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Intentionality score - post
|
11.69 score on a scale
Standard Deviation 2.09
|
11.05 score on a scale
Standard Deviation 4.78
|
12.30 score on a scale
Standard Deviation 2.96
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Anger score - pre
|
14.9 score on a scale
Standard Deviation 4.21
|
14.68 score on a scale
Standard Deviation 5.52
|
12.66 score on a scale
Standard Deviation 4.50
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Anger score - post
|
13.53 score on a scale
Standard Deviation 3.39
|
12.47 score on a scale
Standard Deviation 5.64
|
13.47 score on a scale
Standard Deviation 5.26
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Blame score - pre
|
14.29 score on a scale
Standard Deviation 4.09
|
14.16 score on a scale
Standard Deviation 5.92
|
13.05 score on a scale
Standard Deviation 4.50
|
|
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Blame score - post
|
13 score on a scale
Standard Deviation 3.61
|
13 score on a scale
Standard Deviation 5.73
|
13.63 score on a scale
Standard Deviation 4.42
|
PRIMARY outcome
Timeframe: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)
The SSPA is a verbal role-play assessment in which the subject participates in two 3-minute role-play conversations ("scenes") with the assessor on pre-determined topics (e.g. "Your landlord has not fixed a leak that you told him about last week, and now you are calling him on the phone to follow-up."). Role-plays are tape-recorded and rated by independent coders. Each one of the 17 domains is rated on a 5-point Likert-type scale. Thus, the total score for the task can be ranged from 0 (min) to 85 (max), with higher scores signifying greater social skills. The SSPA has good face validity as a social skill measure and among individuals with schizophrenia it shown excellent inter-rater reliability, good test-retest reliability, and good convergent validity with a measure of activities of daily living. It is a 5-point Likert-type scale with higher scores signifying greater social skill.
Outcome measures
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
|---|---|---|---|
|
Social Skill Performance Assessment
PRE group intervention
|
47.13 score on a scale
Standard Deviation 13.3
|
48.90 score on a scale
Standard Deviation 13.4
|
54 score on a scale
Standard Deviation 16
|
|
Social Skill Performance Assessment
POST group intervention
|
52.39 score on a scale
Standard Deviation 16.6
|
50.20 score on a scale
Standard Deviation 12.7
|
49.70 score on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)
The Wisconsin Quality of Life Scale (W-QLI) is a multidimensional assessment tool designed to measure quality of life, particularly for individuals with mental illness. The scores range from 0 to 7, with the higher score indicating higher social QoL.
Outcome measures
| Measure |
SCIT
n=23 Participants
Social Cognition and Interaction Training: psychosocial group intervention
SCIT: psychosocial group intervention
|
TAFT
n=20 Participants
Therapeutic Alliance Focused Therapy
TAFT: psychosocial group intervention
|
TAU Group
n=20 Participants
Treatment as Usual
|
|---|---|---|---|
|
Wisconsin Social Quality of Life Scale.
PRE group intervention
|
4.48 score on a scale
Standard Deviation 1.22
|
5.22 score on a scale
Standard Deviation 1.35
|
4.78 score on a scale
Standard Deviation 1.40
|
|
Wisconsin Social Quality of Life Scale.
POST group intervention
|
4.61 score on a scale
Standard Deviation 1.31
|
5.23 score on a scale
Standard Deviation 1.53
|
4.77 score on a scale
Standard Deviation 1.32
|
Adverse Events
SCIT
TAFT
TAU - Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place