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Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

NCT ID: NCT03329287

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-06-30

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.

Conditions

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Generalized Anxiety Disorder Major Depressive Disorder

Keywords

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Simplified Cognitive Behavioral Therapy (SCBT) Generalized Anxiety Disorder Depression Operating manual Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SCBT + Drug

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.

Group Type EXPERIMENTAL

SCBT

Intervention Type BEHAVIORAL

SCBT, one hour per session.

SSRIs and/or SNRIs

Intervention Type DRUG

SSRIs and/or SNRIs at a recommended dosage.

Psychological Placebo + Drug

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.

Group Type ACTIVE_COMPARATOR

SSRIs and/or SNRIs

Intervention Type DRUG

SSRIs and/or SNRIs at a recommended dosage.

Psychological Placebo

Intervention Type BEHAVIORAL

Supportive and relaxation therapy, one our per session.

Drug

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

Group Type ACTIVE_COMPARATOR

SSRIs and/or SNRIs

Intervention Type DRUG

SSRIs and/or SNRIs at a recommended dosage.

Interventions

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SCBT

SCBT, one hour per session.

Intervention Type BEHAVIORAL

SSRIs and/or SNRIs

SSRIs and/or SNRIs at a recommended dosage.

Intervention Type DRUG

Psychological Placebo

Supportive and relaxation therapy, one our per session.

Intervention Type BEHAVIORAL

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunbo Li, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunbo Li, PHD

Role: CONTACT

Phone: 86-21-34773243

Email: [email protected]

Facility Contacts

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Chunbo Li, PHD

Role: primary

Other Identifiers

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15411950201

Identifier Type: -

Identifier Source: org_study_id