ClinicalTrials.gg
Status unknownNCT03329287Updated Nov 1, 2017

Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression

An interventional study of SCBT and SSRIs and/or SNRIs in Generalized Anxiety Disorder and Major Depressive Disorder, sponsored by Shanghai Mental Health Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2017, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Generalized Anxiety Disorder with a site in China — 16 open to participants now, 16 under way, 3 of them phase 3. Generalized Anxiety Disorder · China.

Planned enrollment
9th of 20
180 · median 122
Started
2017
the only one that year
No phase
11 of 23
9 open now
Registered
4th of 23
by date
Lead sponsor
2 of 23
Shanghai Mental Health Center

Among the 23 studies in Generalized Anxiety Disorder with a site in China, this one is the 9th largest by planned enrollment of the 20 interventional ones that give a count, is the only one that started in 2017, is one of 11 with no phase, and was the 4th registered.

Generalized Anxiety Disorder

518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.

Browse Generalized Anxiety Disorder studies →

Open to participants now

16 of the 23 studies in Generalized Anxiety Disorder with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Generalized Anxiety Disorder
  • Major Depressive Disorder

Keywords

  • Simplified Cognitive Behavioral Therapy (SCBT)
  • Generalized Anxiety Disorder
  • Depression
  • Operating manual
  • Efficacy
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • 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 · Drug: SSRIs and/or SNRIs

  • 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 · Behavioral: Psychological Placebo

  • Active comparator
    Drug

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

    Drug: SSRIs and/or SNRIs

Interventions

  • BehavioralSCBT

    SCBT, one hour per session.

  • DrugSSRIs and/or SNRIs

    Drug pages: SSRIs · SNRIs

    SSRIs and/or SNRIs at a recommended dosage.

  • BehavioralPsychological Placebo

    Supportive and relaxation therapy, one our per session.

06

What researchers measure

Primary outcomes

  1. changes of The Hamilton Depression Scale (HAMD-17)

    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.

  2. changes of The Hamilton Anxiety Scale (HAMA-14)

    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 outcomes

  1. changes of The Patient Health Questionnaire (PHQ-9)

    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.

  2. changes of The GAD-7

    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.

  3. changes of The Mos 36-item Short Form Health Survey (SF-36)

    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.

  4. changes of Treatment Emergent Symptom Scale (TESS)

    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.

  5. changes of Clinical Global Impression (CGI)

    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.

07

Study locations

1 of 1 sites recruiting
  • Shanghai Mental Health Center
    Shanghai, Shanghai 200030, China
    Recruiting
    • Chunbo Li, PHD · Contactchunbo_li@163.com · 86-21-34773243
    • Chunbo Li, PHD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Mar 2018, 8 months after the start.

Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 8 months is below that.

Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Nov 1, 2017
StartActual
Jul 1, 2017
Primary completionEst.
Mar 30, 2018
CompletionEst.
Jun 30, 2018
Last update
Nov 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03329287
Collaborators
Changhai Hospital, Shanghai 10th People's Hospital, Tongji Hospital, Fudan University, Second Hospital of Shanxi Medical University
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Jul 1, 2017
Primary completion
Mar 30, 2018 (estimated)
Completion
Jun 30, 2018 (estimated)
Last update
Nov 1, 2017

Study contacts

Chunbo Li, PHD
Contact
chunbo_li@163.com
86-21-34773243
Chunbo Li, PHD
principal investigator · Shanghai Mental Health Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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