DepressionCBTNCT01868711
Cognitive Behavior Therapy for Depression
A study testing Cognitive Behavior Therapy in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Psychological mindedness(PM) is a metacognitive process in which the person uses his cognitive and affective abilities to understand his thoughts, feelings, and his behaviors as they interact with his internal experiences and his external experiences in the world. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 2 Jun 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 65 (inclusive).
- Primary DSM-IV-TR diagnosis of major depression
- A negative urine toxicology, i.e., a urine specimen that does not test positive for the use of drugs of abuse or use of benzodiazepines.
- Ability to give informed consent.
- Fluent in English
Who cannot join
- Patients who have a "lifetime" history of Schizophrenia or other current psychotic disorder, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease.
- DSM-V substance abuse or dependence within the past 6 months (except nicotine or caffeine).
- Active suicidal or homicidal ideation, or judged to be at serious suicide risk.
- Any unstable medical or neurological condition.
- Presently receiving psychotherapy or psychotropic medications.
- Prior History of CBT for Depression treatment failure.
- Left-handedness
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
Psychological mindedness(PM) is a metacognitive process in which the person uses his cognitive and affective abilities to understand his thoughts, feelings, and his behaviors as they interact with his internal experiences and his external experiences in the world. It dynamically modifies his behavior to move towards self-actualization in a manner positive to himself and the world. We investigate whether the assessment of PM can distinguish depressed patients who benefit from CBT.
Read the detailed description
Cognitive Behavior Therapy (CBT) is one of the most effective psychotherapy for depression. Yet, it is effective only for 40% of the depressed people who receive this treatment. Currently, there is no method of predicting who can be helped among depressed patients by CBT. In this study, we examine whether the level of psychological mindedness can predict who may benefit from CBT among depressed patients.
Participants who are clinically depressed are randomized to 12 sessions of CBT and supportive therapy. The evaluation process and all sessions will be administered virtually using HIPAA-compliant video teleconferencing. Participants must have access to the internet and have video conferencing capabilities. Besides the virtual sessions, participants will need to come in person once for a urine \& blood test (protocol #6669) and twice for an electroencephalogram (EEG) (protocol #6559). Dr. Jürgen Kayser who is heading the EEG lab is a co-PI on this grant.
Please exercise caution when traveling in public and follow public health guidelines, such as wearing masks in public and avoiding crowds. It would be best if you stay informed of public health recommendations and guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local governments. If you have questions about how you will travel for appointments or do not feel safe traveling, please let us know, and know that you can call to reschedule visits.
It is important to note that subjects who enroll in the study can't take any psychiatric medications, nor can they attend any other psychotherapy besides what is offered in the study. Should the participant decide to make alternations and use medication, this will not affect their participation in psychotherapy or this study.
Participants who are eligible for the study will begin within two weeks after the evaluation visit. An evaluator will rate the HDRS-17 and CG I-Severity. If they are still eligible, they will sign the study consent form, have the study explained, including its risks and possible benefits, as well as alternatives and its voluntary nature. Once they sign the consent form, patients will complete a battery of self-report instruments online. Also, they will be interviewed by a clinician with a structured clinical interview of PM. They will then be randomized between CBT and supportive therapy (control group) and will schedule their weekly virtual sessions with the study therapist. During 12 weeks, they will be clinically monitored by Beck Depression Inventory at the beginning of every session and HDRS-17 every three weeks. They will complete study measures at week six and after the 12 weeks sessions.
Study participants who do not remit (end treatment HDRS-17 > 7) at the end of the CBT trial will receive a referral for alternative psychotherapy per the patient's preference.
- Conditions
- Depression
- Being tested
- Cognitive Behavior Therapy
- Keywords
- Cognitive Behavior Therapy, Self-awarness, Supportive Therapy, Virtual psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called Supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| *Cognitive behavior therapy | Active comparator | Depressed patients will receive 12 virtual sessions of cognitive behavior therapy (CBT) for depression. CBT Includes behavior activation, correcting distorted thoughts, and other tools to reduce symptoms. Receives: Behavioral: Cognitive Behavior Therapy |
| Supportive psychotherapy | Other | Supportive psychotherapy aims to strengthen the patient's ability to cope effectively with various life stressors. Specifically, in our study, supportive psychotherapy will be geared towards reducing or alleviating symptoms of depression. The sessions will be administered virtually. Receives: Behavioral: Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression as measured by the Hamilton Depression Rating Scale
Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (up to 12 weeks).
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2013
- Primary completion1 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Model description
- Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ronit Kishon, New York State Psychiatric Institute
- Investigators
- Ronit Kishon, Ph.D., Principal investigator, New York State Psychiatric Institute, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868711
- Sponsor's protocol ID
- 6806R
- Other IDs
- R21MH121915-01A1
- Acronym
- CBT
- Status last verified
- May 2024
- First submitted
- 20 May 2013
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Mindedness as a Predictor of Success in Cognitive Behavior Therapy for Depressed Patients
- ClinicalTrials.gov ID
- NCT01868711
- Acronym / sponsor ID
- CBT / 6806R
- Conditions
- Depression
- Keywords
- Cognitive Behavior Therapy, Self-awarness, Supportive Therapy, Virtual psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2013 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 4 Jun 2013 (estimated)
- 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.
Psychological mindedness(PM) is a metacognitive process in which the person uses his cognitive and affective abilities to understand his thoughts, feelings, and his behaviors as they interact with his internal experiences and his external experiences in the world. It dynamically modifies his behavior to move towards self-actualization in a manner positive to himself and the world. We investigate whether the assessment of PM can distinguish depressed patients who benefit from CBT.
Detailed description
Cognitive Behavior Therapy (CBT) is one of the most effective psychotherapy for depression. Yet, it is effective only for 40% of the depressed people who receive this treatment. Currently, there is no method of predicting who can be helped among depressed patients by CBT. In this study, we examine whether the level of psychological mindedness can predict who may benefit from CBT among depressed patients.
Participants who are clinically depressed are randomized to 12 sessions of CBT and supportive therapy. The evaluation process and all sessions will be administered virtually using HIPAA-compliant video teleconferencing. Participants must have access to the internet and have video conferencing capabilities. Besides the virtual sessions, participants will need to come in person once for a urine \& blood test (protocol #6669) and twice for an electroencephalogram (EEG) (protocol #6559). Dr. Jürgen Kayser who is heading the EEG lab is a co-PI on this grant.
Please exercise caution when traveling in public and follow public health guidelines, such as wearing masks in public and avoiding crowds. It would be best if you stay informed of public health recommendations and guidelines regarding COVID-19, such as those issued by the Centers for Disease Control (CDC.gov) and local governments. If you have questions about how you will travel for appointments or do not feel safe traveling, please let us know, and know that you can call to reschedule visits.
It is important to note that subjects who enroll in the study can't take any psychiatric medications, nor can they attend any other psychotherapy besides what is offered in the study. Should the participant decide to make alternations and use medication, this will not affect their participation in psychotherapy or this study.
Participants who are eligible for the study will begin within two weeks after the evaluation visit. An evaluator will rate the HDRS-17 and CG I-Severity. If they are still eligible, they will sign the study consent form, have the study explained, including its risks and possible benefits, as well as alternatives and its voluntary nature. Once they sign the consent form, patients will complete a battery of self-report instruments online. Also, they will be interviewed by a clinician with a structured clinical interview of PM. They will then be randomized between CBT and supportive therapy (control group) and will schedule their weekly virtual sessions with the study therapist. During 12 weeks, they will be clinically monitored by Beck Depression Inventory at the beginning of every session and HDRS-17 every three weeks. They will complete study measures at week six and after the 12 weeks sessions.
Study participants who do not remit (end treatment HDRS-17 > 7) at the end of the CBT trial will receive a referral for alternative psychotherapy per the patient's preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Depressed patients will be randomized between cognitive behavor therapy and supportive therapy.
| Arm | Type | Receives |
|---|---|---|
| *Cognitive behavior therapy | Active comparator | Behavioral: Cognitive Behavior TherapyDepressed patients will receive 12 virtual sessions of cognitive behavior therapy (CBT) for depression. CBT Includes behavior activation, correcting distorted thoughts, and other tools to reduce symptoms. |
| Supportive psychotherapy | Other | Behavioral: Cognitive Behavior TherapySupportive psychotherapy aims to strengthen the patient's ability to cope effectively with various life stressors. Specifically, in our study, supportive psychotherapy will be geared towards reducing or alleviating symptoms of depression. The sessions will be administered virtually. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females between the ages of 18 and 65 (inclusive).
- Primary DSM-IV-TR diagnosis of major depression
- A negative urine toxicology, i.e., a urine specimen that does not test positive for the use of drugs of abuse or use of benzodiazepines.
- Ability to give informed consent.
- Fluent in English
Key exclusion criteria (7 listed)
- Patients who have a "lifetime" history of Schizophrenia or other current psychotic disorder, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease.
- DSM-V substance abuse or dependence within the past 6 months (except nicotine or caffeine).
- Active suicidal or homicidal ideation, or judged to be at serious suicide risk.
- Any unstable medical or neurological condition.
- Presently receiving psychotherapy or psychotropic medications.
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 |
|---|---|---|
| Cognitive Behavior TherapyAlso: Supportive psychotherapy | Behavioural | *Cognitive behavior therapy, Supportive psychotherapy |
Primary outcome
Level of depression as measured by the Hamilton Depression Rating Scale
Time frame: Up to 12 weeks.
Outcome measure of depression will be assessed as the change in depression between baseline (pre-treatment) and post treatment (up to 12 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Click here for more information about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ronit Kishon, Ph.D. principal investigator
New York State Psychiatric Institute, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 May 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depression as measured by the Hamilton Depression Rating Scale (time frame: Up to 12 weeks.). 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 17 May 2024.