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Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Primary Purpose

Generalized Anxiety Disorder, Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SCBT
SSRIs and/or SNRIs
Psychological Placebo
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Simplified Cognitive Behavioral Therapy (SCBT), Generalized Anxiety Disorder, Depression, Operating manual, Efficacy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

SCBT + Drug

Psychological Placebo + Drug

Drug

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

changes of The Hamilton Depression Scale (HAMD-17)
Scale total range is 52. Lower score represents a better outcome.
changes of The Hamilton Anxiety Scale (HAMA-14)
Scale total range is 56. Lower score represents a better outcome.

Secondary Outcome Measures

changes of The Patient Health Questionnaire (PHQ-9)
Scale total range is 27. Lower score represents a better outcome.
changes of The GAD-7
Scale total range is 21. Lower score represents a better outcome.
changes of The Mos 36-item Short Form Health Survey (SF-36)
It has nine dimensions, each dimension has an independent fractional formula.
changes of Treatment Emergent Symptom Scale (TESS)
Evaluation of side effects caused by various psychotropic drugs.
changes of Clinical Global Impression (CGI)
Evaluation of clinical efficacy. Lower score represents a better outcome.

Full Information

First Posted
October 26, 2017
Last Updated
October 29, 2017
Sponsor
Shanghai Mental Health Center
Collaborators
Changhai Hospital, Shanghai 10th People's Hospital, Tongji Hospital, Fudan University, Second Hospital of Shanxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03329287
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Changhai Hospital, Shanghai 10th People's Hospital, Tongji Hospital, Fudan University, Second Hospital of Shanxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Major Depressive Disorder
Keywords
Simplified Cognitive Behavioral Therapy (SCBT), Generalized Anxiety Disorder, Depression, Operating manual, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCBT + Drug
Arm Type
Experimental
Arm 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.
Arm Title
Psychological Placebo + Drug
Arm Type
Active Comparator
Arm 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.
Arm Title
Drug
Arm Type
Active Comparator
Arm Description
Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.
Intervention Type
Behavioral
Intervention Name(s)
SCBT
Intervention Description
SCBT, one hour per session.
Intervention Type
Drug
Intervention Name(s)
SSRIs and/or SNRIs
Intervention Description
SSRIs and/or SNRIs at a recommended dosage.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Placebo
Intervention Description
Supportive and relaxation therapy, one our per session.
Primary Outcome Measure Information:
Title
changes of The Hamilton Depression Scale (HAMD-17)
Description
Scale total range is 52. Lower score represents a better outcome.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Title
changes of The Hamilton Anxiety Scale (HAMA-14)
Description
Scale total range is 56. Lower score represents a better outcome.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Secondary Outcome Measure Information:
Title
changes of The Patient Health Questionnaire (PHQ-9)
Description
Scale total range is 27. Lower score represents a better outcome.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Title
changes of The GAD-7
Description
Scale total range is 21. Lower score represents a better outcome.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Title
changes of The Mos 36-item Short Form Health Survey (SF-36)
Description
It has nine dimensions, each dimension has an independent fractional formula.
Time Frame
At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Title
changes of Treatment Emergent Symptom Scale (TESS)
Description
Evaluation of side effects caused by various psychotropic drugs.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Title
changes of Clinical Global Impression (CGI)
Description
Evaluation of clinical efficacy. Lower score represents a better outcome.
Time Frame
At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunbo Li, PHD
Phone
86-21-34773243
Email
chunbo_li@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunbo Li, PHD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunbo Li, PHD
Phone
86-21-34773243
Email
chunbo_li@163.com
First Name & Middle Initial & Last Name & Degree
Chunbo Li, PHD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD data

Learn more about this trial

Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

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