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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Tongji Hospital | OTHER |
| Fudan University |
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This trial attempts to evaluate the treatment efficacy of Simplified Cognitive Behavioral Therapy (SCBT) and its safety among schizophrenia patients. Half of participants will be randomized to accept SCBT.
The investigators have developed a simplified but standardized set of cognitive behavioral treatment (including the therapist's manual and patient self-help manual) for the patients of generalized anxiety disorder and depression, known as Simplified Cognitive Behavioral Therapy (SCBT). SCBT is the main psychological intervention of this study. The aim of this study is to verify its efficacy and applicability using a multi-center, randomized, placebo controlled and single-blind design, and to optimize the treatment program. The investigators hypothesize that SCBT is effective in patients with depression or anxiety, and the manual is easily-operated for the therapists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCBT + Drug | Experimental | Participants receive SCBT at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage. |
|
| Psychological Placebo + Drug | Active Comparator | Participants receive supportive and relaxation therapy at a frequency of twice a week in the first 4 weeks, and once a week in the following 4 weeks. They also take SSRIs and/or SNRIs through the trial at a recommended dosage. |
|
| Drug | Active Comparator | Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCBT | Behavioral | SCBT, one hour per session. |
| |
| SSRIs and/or SNRIs |
| Measure | Description | Time Frame |
|---|---|---|
| changes of The Hamilton Depression Scale (HAMD-17) | Scale total range is 52. Lower score represents a better outcome. | At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| changes of The Hamilton Anxiety Scale (HAMA-14) | Scale total range is 56. Lower score represents a better outcome. | At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| Measure | Description | Time Frame |
|---|---|---|
| changes of The Patient Health Questionnaire (PHQ-9) | Scale total range is 27. Lower score represents a better outcome. | At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| changes of The GAD-7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunbo Li, PHD | Contact | 86-21-34773243 | chunbo_li@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunbo Li, PHD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
No plan to share IPD data
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000068760 | Serotonin and Noradrenaline Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
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| Drug |
SSRIs and/or SNRIs at a recommended dosage. |
|
| Psychological Placebo | Behavioral | Supportive and relaxation therapy, one our per session. |
|
Scale total range is 21. Lower score represents a better outcome.
| At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| changes of The Mos 36-item Short Form Health Survey (SF-36) | It has nine dimensions, each dimension has an independent fractional formula. | At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| changes of Treatment Emergent Symptom Scale (TESS) | Evaluation of side effects caused by various psychotropic drugs. | At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| changes of Clinical Global Impression (CGI) | Evaluation of clinical efficacy. Lower score represents a better outcome. | At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week. |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D045505 | Physiological Effects of Drugs |