Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Not Applicable

• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder
• Interventions: Behavioral: SCBT; Drug: SSRIs and/or SNRIs; Behavioral: Psychological Placebo

• Registration Number: NCT03329287
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-29
• Last Update Submitted: 2017-10-29
• Study First Posted: 2017-11-01
• Last Update Posted: 2017-11-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

1. Suffering from serious physical illness;
2. Having self-injurious behavior, suicidal tendencies;
3. Having bipolar disorder;
4. Having psychotic symptoms;
5. Having obsessive-compulsive disorder, post-traumatic stress disorder;
6. Pregnant women or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCBT + Drug	SCBT	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.
SCBT + Drug	SSRIs and/or SNRIs	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	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.
Psychological Placebo + Drug	Psychological Placebo	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	Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.

Primary Outcome Measures

Name	Time	Method
changes of The Hamilton Depression Scale (HAMD-17)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 52. Lower score represents a better outcome.
changes of The Hamilton Anxiety Scale (HAMA-14)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 56. Lower score represents a better outcome.

Secondary Outcome Measures

Name	Time	Method
changes of The Patient Health Questionnaire (PHQ-9)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 27. Lower score represents a better outcome.
changes of The GAD-7	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 21. Lower score represents a better outcome.
changes of The Mos 36-item Short Form Health Survey (SF-36)	At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.	It has nine dimensions, each dimension has an independent fractional formula.
changes of Treatment Emergent Symptom Scale (TESS)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Evaluation of side effects caused by various psychotropic drugs.
changes of Clinical Global Impression (CGI)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Evaluation of clinical efficacy. Lower score represents a better outcome.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China