The Effectiveness and Efficacy of the Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective for Patients With Mental Health Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The Greek verbal memory test
研究概览
简要总结
The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.
详细描述
Reintegration into society and good functional outcome by people with mental health disorders is frequently the result of the combination of pharmacotherapy and individual cognitive behavioral psychotherapy. The effectiveness and efficacy of this combination of treatments under the recovery perspective by anxiety disorders, depressive disorders, PTSD, bipolar disorders, schizophrenia and psychotic disorders, by obsessive-compulsive disorders and by personality disorders presents the main goal of this research protocol. Recovery means that people learn through the trherapy to be responsible towards their own problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65,
- •Diagnosis: anxiety disorders, depression, obsessive-compulsive disorders, PTSD, personality disorders, bipolar disorders, schizophrenia and psychotic disorders.
排除标准
- •*Substance abuse and head injury.
研究组 & 干预措施
Group E
The combination of pharmacotherapy (antipsychotics (clozapine and atypical antipsychotics)) , anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders.
20 patients
干预措施: Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders (Combination Product)
Group C
The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.
15 patients
干预措施: Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. (Combination Product)
Group F
The combination of pharmacotherapy (antidepressants (SSRI, SNRI), anxiolytics (Tavor, clonotril, lexotanil) antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by personality disorders.
20 patients (2 narcistic personality disorder, 5 borderline personality disorder, 4 obsessive-compulsive disorder, 5 avoidant personality disorder, 4 depedent personality disorder)
干预措施: Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disorders (Combination Product)
Group A
The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.
20 patients
干预措施: Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression. (Combination Product)
Group B
The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD.
12 patients
干预措施: Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD (Combination Product)
Group D
The combination of pharmacotherapy (anxiolytics ((Tavor, clonotril, lexotanil), antidperessants (SSRI, SNRI), mood stabilizers (Lithium, depakine) and antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorders.
15 patients
干预措施: Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder (Combination Product)
结局指标
主要结局
The Greek verbal memory test
时间窗: Follow-up up to 24 weeks
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Clinical Global Impression Scale (CGI)
时间窗: Follow-up up to 24 weeks
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
MCCB BACS symbol coding
时间窗: Preintervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB BACS symbol coding
时间窗: Immediately after the intervention
It measures speed of processing. Minimum 0, maximum 110, high scores better
MCCB Wechsler memory scale-spatial span
时间窗: Preintervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Wechsler memory scale-spatial span
时间窗: Immediately after the intervention
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Neurospychological Assessment Battery (NAB)
时间窗: Preintervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Neurospychological Assessment Battery (NAB)
时间窗: Immediately after the intervention
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Brief visuospatial memory test
时间窗: Preintervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
MCCB Brief visuospatial memory test
时间窗: Immediately after the intervention
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
The Greek verbal memory test
时间窗: Preintervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
The Greek verbal memory test
时间窗: Immediately after the intervention
It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.
SCL-90-R
时间窗: Preintervention
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
SCL-90-R
时间窗: Immediately after the intervention
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
PANNS total
时间窗: Preintervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
RAS-DS total
时间窗: Preintervention
It measures recovery. Minimum 0, maximum 152. High scores better.
PANNS total
时间窗: Immediately after the intervention
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total
时间窗: Preintervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
时间窗: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
时间窗: Immediately after the intervention
It measures recovery. Minimum 0, maximum 152. High scores better.
The Clinical Global Impression Scale (CGI)
时间窗: Preintervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
The Clinical Global Impression Scale (CGI)
时间窗: Immediately after the intervention
It measures severity of illness. Minimum 0, Maximum 7, low scores better.
SRSDA
时间窗: Preintervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA
时间窗: Immediately after the intervention
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA B
时间窗: Preintervention
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
SRSDA B
时间窗: Immediately after the intervention
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Hamilton Depression Scale
时间窗: Preintervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
时间窗: Immediately after the intervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Montgomery and Asperg depression scale
时间窗: Preintervention
It measures depression. Minimum 0, maximum 60. Low scores better.
Montgomery and Asperg depression scale
时间窗: Immediately after the intervention
It measures depression. Minimum 0, maximum 60. Low scores better.
The Altman self-rating scale
时间窗: Preintervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Altman self-rating scale
时间窗: Immediately after the intervention
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Young mania rating scale
时间窗: Preintervention
It measures mania. Minimum 0, maximum 60. Low scores better
The Young mania rating scale
时间窗: Immediately after the intervention
It measures mania. Minimum 0, maximum 60. Low scores better
PSYRAT H
时间窗: Preintervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT H
时间窗: Immediately after the intervention
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT D
时间窗: Preintervention
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
PSYRAT D
时间窗: Immediately after the intervention
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
MCCB Wechsler memory scale-spatial span
时间窗: Follow-up up to 24 weeks
It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.
MCCB Neurospychological Assessment Battery (NAB)
时间窗: Follow-up up to 24 weeks
It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better
MCCB Brief visuospatial memory test
时间窗: Follow-up up to 24 weeks
It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better
SCL-90-R
时间窗: Follow-up up to 24 weeks
It evaluates psychopathology. T\>60 means psychopathology. Low scores better
PANNS total
时间窗: Follow-up up to 24 weeks
It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better
WHODAS total
时间窗: Follow-up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
时间窗: Follow-up up to 24 weeks
It measures recovery. Minimum 0, maximum 152. High scores better.
SRSDA
时间窗: Follow-up up to 24 weeks
It measures Depression. Minimum 0, maximum 14 or higher. Low scores better
SRSDA B
时间窗: Follow-up up to 24 weeks
It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better
Hamilton Depression Scale
时间窗: Follow-up up to 24 weeks
It measures depression. Minimum 0, maximum 23. Low scores better.
Montgomery and Asperg depression scale
时间窗: Follow-up up to 24 weeks
It measures depression. Minimum 0, maximum 60. Low scores better.
The Altman self-rating scale
时间窗: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 6 or higher. Low scores better.
The Young mania rating scale
时间窗: Follow-up up to 24 weeks
It measures mania. Minimum 0, maximum 60. Low scores better
PSYRAT H
时间窗: Follow-up up to 24 weeks
It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.
PSYRAT D
时间窗: Follow-up up to 24 weeks
It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better
MCCB BACS symbol coding
时间窗: Follow-up up to 24 weeks
It measures speed of processing. Minimum 0, maximum 110, high scores better
次要结局
- WAIS(Preintervention)
研究者
Dr. Stavroula Rakitzi
Dr. phil., Dipl.-Psych., Clinical psychologist and cognitive behavioral psychotherapist
Rakitzi, Stavroula