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The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPYFLEC cognitive remediation training | Experimental | REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training. |
|
| Leisure group | Active Comparator | Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repyflec cognitive remediation training | Behavioral | Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform. |
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function | 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. | Change from baseline in executive function at 16 weeks (post-treatment) |
| Executive Function | 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. | Change from baseline in executive functioning at 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial Functioning | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aida Farreny, PhD Psycho. | Fundació Sant Joan de Déu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc Sanitari Sant Joan de Déu | Sant Boi de Llobregat | Barcelona | 08930 | Spain |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Leisure Group | Leisure group has got same number of sessions and timing than experimental group |
| BG001 | Repyflec Training | Cognitive remediation treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Executive Function | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in executive function at 16 weeks (post-treatment) |
|
At baseline (week 0), post-treatment (week 16) and follow-up assessments (week 40). Two times per week during 16 weeks of intervention groups.
There are not expected risks for the testing,interviews or REPYFLEC and control groups.However,there is the possibility that patients could get tired or feel a bit uncomfortable after completing groups or assessments.At interviews and cognitive testing there will be the option of taking short breaks to avoid fatigue and potential discomfort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leisure Group | Stimulating activities without specific goals and focused on leisure |
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It would be useful to widen the assessment of cognitive measures and negative symptoms. Metacognition has not been appropriately studied.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aida Farreny | Parc Sanitari Sant Joan de Déu | +34 936406350 | 2373 | afarreny@pssjd.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Change from baseline in social functioning scales at 16 weeks |
| Psychosocial Functioning | 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. | Change from baseline in social functioning scales at 40 weeks |
| Psychiatric Symptoms | The 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. | Change from baseline in psychiatric symptoms scales at 16 weeks |
| Psychiatric Symptoms | The 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. | Change from baseline in psychiatric symptoms scales at 40 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| REPYFLEC Cognitive Remediation Group Training |
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. |
| OG001 | Leisure & Socialization Group | 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. |
|
|
|
| Primary | Executive Function | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in executive functioning at 40 weeks |
|
|
|
|
| Secondary | Psychosocial Functioning | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in social functioning scales at 16 weeks |
|
|
|
|
| Secondary | Psychosocial Functioning | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in social functioning scales at 40 weeks |
|
|
|
|
| Secondary | Psychiatric Symptoms | The 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in psychiatric symptoms scales at 16 weeks |
|
|
|
|
| Secondary | Psychiatric Symptoms | The 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. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline in psychiatric symptoms scales at 40 weeks |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Repyflec Training | Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility | 0 | 29 | 0 | 29 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| General Psychopathology (from 16 to 112) |
|
| PANSS Total score (min. 30-max. 210) |
|
| No |
| Superiority or Other |
| General Psychopathology (from 16 to 112) |
|
| PANSS Total score (min. 30- max. 210) |
|
| No |
| Superiority or Other |