Trial Outcomes & Findings for Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia (NCT NCT01279070)
NCT ID: NCT01279070
Last Updated: 2013-08-23
Results Overview
Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.
COMPLETED
PHASE4
62 participants
Change from baseline in executive function at 16 weeks (post-treatment)
2013-08-23
Participant Flow
Recruitment started on January 2007 and finished on May 2010. We have worked in different outpatient Rehabilitation Centers and we incorporated experimental and control group as a part of their rehabilitation planning. We have worked in 6 different centers.
Participant milestones
| Measure |
Experimental Group (Repyflec Cognitive Remediation)
Cognitive remediation (CR) group training (Repyflec)
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF).
|
Leisure Group (Control Group)
Leisure group
Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, "coffee \& talk", etc.) over 4 months twice a week and lasting 1 h.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
28
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Experimental Group (Repyflec Cognitive Remediation)
Cognitive remediation (CR) group training (Repyflec)
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF).
|
Leisure Group (Control Group)
Leisure group
Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, "coffee \& talk", etc.) over 4 months twice a week and lasting 1 h.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Acute exacerbation
|
3
|
1
|
Baseline Characteristics
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Baseline characteristics by cohort
| Measure |
Leisure Group
n=28 Participants
Leisure group has got same number of sessions and timing than experimental group
|
Repyflec Training
n=34 Participants
Cognitive remediation treatment
|
Total
n=62 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
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 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
|
41.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
28 participants
n=5 Participants
|
34 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in executive function at 16 weeks (post-treatment)Population: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.
Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=29 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=24 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Executive Function
BADS total standardized score (from 12 to 129)
|
99.5 units on a scale
Standard Deviation 14.5
|
95.7 units on a scale
Standard Deviation 13.5
|
|
Executive Function
BADS Key search subscale (from 0 to 4)
|
2.7 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Change from baseline in executive functioning at 40 weeksPopulation: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.
Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=28 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=19 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Executive Function
BADS standardized total score (min.12-max.129)
|
101.8 units on a scale
Standard Deviation 10.1
|
94.5 units on a scale
Standard Deviation 14.7
|
|
Executive Function
BADS Key search subscale (from 0 to 4)
|
3 units on a scale
Standard Deviation 1.1
|
1.7 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Change from baseline in social functioning scales at 16 weeksPopulation: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.
The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result. The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=29 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=24 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Psychosocial Functioning
LSP Total Score (min. 39-max. 156)
|
137.4 units on a scale
Standard Deviation 6.9
|
133.6 units on a scale
Standard Deviation 11.4
|
|
Psychosocial Functioning
SFS Total Score (min. 0-max. 223)
|
108.8 units on a scale
Standard Deviation 17.6
|
105.9 units on a scale
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Change from baseline in social functioning scales at 40 weeksPopulation: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.
The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result. The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=28 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=19 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Psychosocial Functioning
LSP Total Score (min. 39-max. 156)
|
135.7 units on a scale
Standard Deviation 7.7
|
132.9 units on a scale
Standard Deviation 12
|
|
Psychosocial Functioning
SFS Total Score (min. 0-max. 223)
|
107 units on a scale
Standard Deviation 16.6
|
107.2 units on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Change from baseline in psychiatric symptoms scales at 16 weeksThe Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=29 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=24 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Psychiatric Symptoms
Positive (from 7 to 49)
|
11.5 units on a scale
Standard Deviation 2.9
|
12.8 units on a scale
Standard Deviation 3.5
|
|
Psychiatric Symptoms
Negative (from 7 to 49)
|
16.6 units on a scale
Standard Deviation 4.1
|
17.5 units on a scale
Standard Deviation 5.2
|
|
Psychiatric Symptoms
General Psychopathology (from 16 to 112)
|
27.5 units on a scale
Standard Deviation 6
|
30.1 units on a scale
Standard Deviation 6.1
|
|
Psychiatric Symptoms
PANSS Total score (min. 30-max. 210)
|
55.6 units on a scale
Standard Deviation 10.6
|
60.4 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Change from baseline in psychiatric symptoms scales at 40 weeksThe Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.
Outcome measures
| Measure |
REPYFLEC Cognitive Remediation Group Training
n=28 Participants
REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
|
Leisure & Socialization Group
n=19 Participants
The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, "coffee \& talk", geography review, etc.)without specific goals.
|
|---|---|---|
|
Psychiatric Symptoms
Positive (from 7 to 49)
|
12.9 units on a scale
Standard Deviation 3.3
|
14 units on a scale
Standard Deviation 4.8
|
|
Psychiatric Symptoms
Negative (from 7 to 49)
|
17.6 units on a scale
Standard Deviation 3.7
|
16.9 units on a scale
Standard Deviation 3.8
|
|
Psychiatric Symptoms
General Psychopathology (from 16 to 112)
|
30.8 units on a scale
Standard Deviation 5.7
|
30.8 units on a scale
Standard Deviation 5
|
|
Psychiatric Symptoms
PANSS Total score (min. 30- max. 210)
|
61.4 units on a scale
Standard Deviation 9.5
|
61.8 units on a scale
Standard Deviation 10.5
|
Adverse Events
Leisure Group
Repyflec Training
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