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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329287

Enrollment

180

Registered

2017-11-01

Start date

2017-07-01

Completion date

2018-06-30

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder, Major Depressive Disorder

Keywords

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

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.

Interventions

BEHAVIORALSCBT

SCBT, one hour per session.

DRUGSSRIs and/or SNRIs

SSRIs and/or SNRIs at a recommended dosage.

BEHAVIORALPsychological Placebo

Supportive and relaxation therapy, one our per session.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
changes of The Hamilton Depression Scale (HAMD-17)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 52. Lower score represents a better outcome.
changes of The Hamilton Anxiety Scale (HAMA-14)	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 56. Lower score represents a better outcome.

Secondary

Measure	Time frame	Description
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.	It has nine dimensions, each dimension has an independent fractional formula.
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.	Scale total range is 27. Lower score represents a better outcome.
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.	Evaluation of clinical efficacy. Lower score represents a better outcome.
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.	Evaluation of side effects caused by various psychotropic drugs.
changes of The GAD-7	At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.	Scale total range is 21. Lower score represents a better outcome.

Countries

China

Contacts

Primary ContactChunbo Li, PHD

chunbo_li@163.com86-21-34773243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026