Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy, Prediction and Methodological Evaluation of Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression: a Multicenter, Randomized, Controlled Study

Conditions
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Generalized Anxiety Disorder, Major Depressive Disorder

Intervention / Treatment
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* Behavioral: SCBT
* Drug: SSRIs and/or SNRIs
* Behavioral: Psychological Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Adults aged 18-60 years old, male and female; 2. With primary school or above education levels; 3. Without vision, hearing or communication difficulties; 4. DSM-V diagnosis of generalized anxiety disorder and/or major depressive disorder; 5. HAMA-14 score greater than or equal to 14 points, less than 29 pionts; HAMD-17 score greater than or equal to 7 points, less than 24 points; 6. GAD-7 score greater than or equal to 5 points; PHQ-9 score greater than or equal to 5 points; 7. In the last 2 months, did not accept other forms of psychological treatment, or treatment is ineffective; 8. Voluntarily participate in and sign informed consent. Exclusion Criteria: Suffering from serious physical illness; Having self-injurious behavior, suicidal tendencies; Having bipolar disorder; Having psychotic symptoms; Having obsessive-compulsive disorder, post-traumatic stress disorder; Pregnant women or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCBT + Drug<br>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<br>* SCBT, one hour per session.<br>Drug: SSRIs and/or SNRIs<br>* SSRIs and/or SNRIs at a recommended dosage.<br>|
| Active Comparator: Psychological Placebo + Drug<br>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<br>* SSRIs and/or SNRIs at a recommended dosage.<br>Behavioral: Psychological Placebo<br>* Supportive and relaxation therapy, one our per session.<br>|
| Active Comparator: Drug<br>Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage. | Drug: SSRIs and/or SNRIs<br>* SSRIs and/or SNRIs at a recommended dosage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simplified Cognitive Behavioral Therapy (SCBT), Generalized Anxiety Disorder, Depression, Operating manual, Efficacy