Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03329287
• Other study ID #: 15411950201
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2017
• Last updated: October 29, 2017
• Start date: July 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2017
• Source: Shanghai Mental Health Center
• Contact: Chunbo Li, PHD
• Phone: 86-21-34773243
• Email: chunbo_li[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder

Intervention

Behavioral:
• SCBT
SCBT, one hour per session.

Drug:
• SSRIs and/or SNRIs
SSRIs and/or SNRIs at a recommended dosage.

Behavioral:
• Psychological Placebo
Supportive and relaxation therapy, one our per session.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Changhai Hospital, Fudan University, Second Hospital of Shanxi Medical University, Shanghai 10th People's Hospital, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.