Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

Efficacy, Prediction and Methodological Evaluation of Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression: a Multicenter, Randomized, Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder
• Intervention / Treatment: Behavioral: SCBT; Drug: SSRIs and/or SNRIs; Behavioral: Psychological Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: SCBT; SCBT, one hour per session.; Drug: SSRIs and/or SNRIs; SSRIs and/or SNRIs at a recommended dosage.
Active Comparator: 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.	Drug: SSRIs and/or SNRIs; SSRIs and/or SNRIs at a recommended dosage.; Behavioral: Psychological Placebo; Supportive and relaxation therapy, one our per session.
Active Comparator: Drug; Participants only take SSRIs and/or SNRIs through the trial at a recommended dosage.	Drug: SSRIs and/or SNRIs; SSRIs and/or SNRIs at a recommended dosage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of The Patient Health Questionnaire (PHQ-9)	Scale total range is 27. 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 GAD-7	Scale total range is 21. 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 Mos 36-item Short Form Health Survey (SF-36)	It has nine dimensions, each dimension has an independent fractional formula.	At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.
changes of Treatment Emergent Symptom Scale (TESS)	Evaluation of side effects caused by various psychotropic drugs.	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)	Evaluation of clinical efficacy. 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.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Changhai Hospital; Fudan University; Tongji Hospital; Shanghai 10th People's Hospital; Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Chunbo Li, PHD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): March 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Generalized Anxiety Disorder; Efficacy; Simplified Cognitive Behavioral Therapy (SCBT); Operating manual
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Depressive Disorder, Major
• Other Study ID Numbers: 15411950201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No