Generalized Anxiety DisorderNCT03329287
Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression
A study testing SCBT and SSRIs and/or SNRIs in people with Generalized Anxiety Disorder and Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder, Major Depressive Disorder
- What is being tested?
- SCBT and SSRIs and/or SNRIs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Chunbo Li, PHD, 86-21-34773243, chunbo_li@163.com
Chunbo Li, PHD
About this study
Official title: 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.
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.
- Being tested
- SCBT, SSRIs and/or SNRIs, Psychological Placebo
- Keywords
- Simplified Cognitive Behavioral Therapy (SCBT), Generalized Anxiety Disorder, Depression, Operating manual, Efficacy
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCBTBehavioural
SCBT, one hour per session.
SSRIs and/or SNRIsDrug
SSRIs and/or SNRIs at a recommended dosage.
Psychological PlaceboBehavioural
Supportive and relaxation therapy, one our per session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: SSRIs and/or SNRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of The Hamilton Depression Scale (HAMD-17)
Scale total range is 52. Lower score represents a better outcome.
Measured: 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.
Measured: 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)
Scale total range is 27. Lower score represents a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jul 2017
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, Tongji Hospital, Fudan University, Second Hospital of Shanxi Medical University
- Responsible party
- Sponsor
- Investigators
- Chunbo Li, PHD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329287
- Sponsor's protocol ID
- 15411950201
- Status last verified
- Jul 2017
- First submitted
- 26 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD data
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Prediction and Methodological Evaluation of Simplified Cognitive Behavioral Therapy for Generalized Anxiety Disorder and Depression: a Multicenter, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03329287
- Acronym / sponsor ID
- 15411950201
- Keywords
- Simplified Cognitive Behavioral Therapy (SCBT), Generalized Anxiety Disorder, Depression, Operating manual, Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, Tongji Hospital, Fudan University, Second Hospital of Shanxi Medical University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCBT + Drug | Experimental | Behavioral: SCBT, Drug: SSRIs and/or SNRIsParticipants 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. |
| Psychological Placebo + Drug | Active comparator | Drug: SSRIs and/or SNRIs, Behavioral: Psychological PlaceboParticipants 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 | Active comparator | Drug: SSRIs and/or SNRIsParticipants only take SSRIs and/or SNRIs through the trial at a recommended dosage. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCBTSCBT, one hour per session. | Behavioural | SCBT + Drug |
| SSRIs and/or SNRIsSSRIs and/or SNRIs at a recommended dosage. | Drug | Drug, Psychological Placebo + Drug, SCBT + Drug |
| Psychological PlaceboSupportive and relaxation therapy, one our per session. | Behavioural | Psychological Placebo + Drug |
Primary outcome
changes of The Hamilton Depression Scale (HAMD-17)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
changes of The Patient Health Questionnaire (PHQ-9)
Time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
changes of The GAD-7
Time frame: 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)
Time frame: At baseline, 4-week, 8-week, 12-week, 20-week, 32-week and 56-week.
changes of Treatment Emergent Symptom Scale (TESS)
Time frame: 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)
Time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No. No plan to share IPD data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunbo Li, PHD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCBT and SSRIs and/or SNRIs in people with Generalized Anxiety Disorder and Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunbo Li, PHD (86-21-34773243, chunbo_li@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of The Hamilton Depression Scale (HAMD-17) (time frame: At baseline, 2-week, 4-week, 6-week, 8-week, 12-week, 20-week, 32-week and 56-week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.