Clinical trial NCT03329287: Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression
Official title: Efficacy, Prediction and Methodological Evaluation of Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression: a Multicenter, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Generalized Anxiety Disorder
Major Depressive Disorder
Keywords: Simplified Cognitive Behavioral Therapy (SCBT)
Generalized Anxiety Disorder
Depression
Operating manual
Efficacy
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: Tongji Hospital
name: Fudan University
name: Second Hospital of Shanxi Medical University
First posted: 2017-11-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes of The Hamilton Depression Scale (HAMD-17)
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
measure: changes of The Hamilton Anxiety Scale (HAMA-14)
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Secondary outcomes:
measure: changes of The Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
measure: changes of The GAD-7
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
measure: changes of The Mos 36-item Short Form Health Survey (SF-36)
timeFrame: At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.
measure: changes of Treatment Emergent Symptom Scale (TESS)
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
measure: changes of Clinical Global Impression (CGI)
timeFrame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Chunbo Li, PHD
role: PRINCIPAL_INVESTIGATOR
References: