An interventional study of SCBT and SSRIs and/or SNRIs in Generalized Anxiety Disorder and Major Depressive Disorder, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: SCBT · Drug: SSRIs and/or SNRIs
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: SSRIs and/or SNRIs · Behavioral: Psychological Placebo
Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.
Drug: SSRIs and/or SNRIs
SCBT, one hour per session.
SSRIs and/or SNRIs at a recommended dosage.
Supportive and relaxation therapy, one our per session.
changes of The Hamilton Depression Scale (HAMD-17)
Scale total range is 52. Lower score represents a better outcome.
Time frame: 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.
Time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
changes of The Patient Health Questionnaire (PHQ-9)
Scale total range is 27. Lower score represents a better outcome.
Time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
changes of The GAD-7
Scale total range is 21. Lower score represents a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Plan to share: No — No plan to share IPD data
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center