Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

NCT03329287 | Unknown

• 1 other identifier: 15411950201
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• 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.

• changes of The GAD-7

  At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.

• 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.

• 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.

• 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.

Study Arms (3)

SCBT + Drug

EXPERIMENTAL

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.

Behavioral: SCBT; Drug: SSRIs and/or SNRIs

Psychological Placebo + Drug

ACTIVE COMPARATOR

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; Behavioral: Psychological Placebo

Drug

ACTIVE COMPARATOR

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

Drug: SSRIs and/or SNRIs

Interventions

SCBT BEHAVIORAL

SCBT, one hour per session.

SCBT + Drug

SSRIs and/or SNRIs DRUG

SSRIs and/or SNRIs at a recommended dosage.

Drug; Psychological Placebo + Drug; SCBT + Drug

Psychological Placebo BEHAVIORAL

Supportive and relaxation therapy, one our per session.

Psychological Placebo + Drug

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Changhai Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Tongji Hospital: collaborator
• Fudan University: collaborator
• Second Hospital of Shanxi Medical University: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depressive Disorder, Major; Depression

Interventions

Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Physiological Effects of Drugs

Study Officials

• Chunbo Li, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunbo Li, PHD

CONTACT

86-21-34773243; chunbo_li@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 1, 2017
• Study Start: July 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)