Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Shanghai Mental Health Center

Status: Unknown

Conditions: Major Depressive Disorder; Generalized Anxiety Disorder

Treatments: Drug: SSRIs and/or SNRIs; Behavioral: SCBT; Behavioral: Psychological Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03329287

15411950201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

SCBT + Drug

Experimental group

Description:

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.

Treatment:

Behavioral: SCBT

Drug: SSRIs and/or SNRIs

Psychological Placebo + Drug

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychological Placebo

Drug: SSRIs and/or SNRIs

Drug

Active Comparator group

Description:

Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.

Treatment:

Drug: SSRIs and/or SNRIs