Major Depressive DisorderNCT01207271
A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
A study testing Cognitive Therapy and Supportive-Expressive Psychodynamic Therapy in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers. Hypothesized mediators of treatment will also be examined. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Therapy and Supportive-Expressive Psychodynamic Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 9 Dec 2014
- 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
- Confirmed diagnosis of major depressive disorder
- Able to read at the 4th grade level or higher
- Willingness to be randomized and participate in research
Who cannot join
- Current or past diagnosis of schizophrenia, seizure disorder, bipolar disorder, psychotic features, or clinically significant organic pathology
- Significant suicidal risk/ideation requiring immediate referral for more intensive treatment, or specific gesture in the last 6 months
- Current substance abuse or dependence requiring immediate referral to substance abuse program
- Acute medical problem requiring immediate inpatient treatment
- Need for referral to a partial hospitalization program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings
The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers.
Hypothesized mediators of treatment will also be examined.
Read the detailed description
The goal of this study is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder (MDD). The specific aims are (1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with MDD and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and quality of life.
Patient mediators of outcome will also be examined through an additional grant awarded to Paul Crits-Christoph, Ph.D. This grant was funded by the National Institutes of Mental Health - RO1MH092363-01. This grant is entitled:"The mechanisms of cognitive and dynamic therapy in community settings."
Recruitment will occur solely through community mental health clinics in and around Philadelphia.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Therapy, Supportive-Expressive Psychodynamic Therapy
- Keywords
- depression, community mental health, treatment, psychotherapy, mediators
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Also called Cognitive Behavioral Therapy, CBT
16 sessions of cognitive therapy administered weekly by a community mental health therapist
Supportive-Expressive Psychodynamic TherapyBehavioural
Also called Psychodynamic Psychotherapy, Short Term Dynamic Therapy
16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Experimental | Not described Receives: Behavioral: Cognitive Therapy |
| Dynamic Therapy | Experimental | Not described Receives: Behavioral: Supportive-Expressive Psychodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
Measured: 6 months
Secondary outcomes (8)
BASIS-24
Measured: 6 months
Beck Depression Inventory - II (BDI-II)
Measured: 6 months
Medical Outcomes Study 36-Item Short Form (SF-36)
Measure of general functionality
Measured: 6 months
Quality of Life Inventory (QOLI)
Measured: 6 months
Ways of Responding (WOR)
Measured: 2 months
Dysfunctional Attitudes Scale (DAS)
Measured: 2 months
Psychological Distance Scaling Task (PDST)
Measured: 2 months
Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startNov 2010
- Primary completion9 Dec 2014
- Study completion9 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Beth Gibbons, Ph.D., Principal investigator, University of PennsylvaniaPaul Crits-Christoph, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207271
- Sponsor's protocol ID
- R01HS018440
- Status last verified
- Apr 2017
- First submitted
- 21 Sep 2010
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Connolly Gibbons MB, Gallop R, Thompson D, Luther D, Crits-Christoph K, Jacobs J, Yin S, Crits-Christoph P. Comparative Effectiveness of Cognitive Therapy and Dynamic Psychotherapy for Major Depressive Disorder in a Community Mental Health Setting: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2016 Sep 1;73(9):904-11. doi: 10.1001/jamapsychiatry.2016.1720.
PubMed 27487573Connolly Gibbons MB, Mack R, Lee J, Gallop R, Thompson D, Burock D, Crits-Christoph P. Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial. BMC Psychol. 2014 Nov 11;2(1):47. doi: 10.1186/s40359-014-0047-y. eCollection 2014.
PubMed 25566391
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive and Dynamic Therapy for MDD in Community Settings
- ClinicalTrials.gov ID
- NCT01207271
- Acronym / sponsor ID
- R01HS018440
- Conditions
- Major Depressive Disorder
- Keywords
- depression, community mental health, treatment, psychotherapy, mediators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- 9 Dec 2014 (actual)
- Study completion
- 9 Dec 2014 (actual)
- First posted
- 22 Sep 2010 (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.
The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers.
Hypothesized mediators of treatment will also be examined.
Detailed description
The goal of this study is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder (MDD). The specific aims are (1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with MDD and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and quality of life.
Patient mediators of outcome will also be examined through an additional grant awarded to Paul Crits-Christoph, Ph.D. This grant was funded by the National Institutes of Mental Health - RO1MH092363-01. This grant is entitled:"The mechanisms of cognitive and dynamic therapy in community settings."
Recruitment will occur solely through community mental health clinics in and around Philadelphia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy | Experimental | Behavioral: Cognitive Therapy |
| Dynamic Therapy | Experimental | Behavioral: Supportive-Expressive Psychodynamic Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of major depressive disorder
- Able to read at the 4th grade level or higher
- Willingness to be randomized and participate in research
Key exclusion criteria (5 listed)
- Current or past diagnosis of schizophrenia, seizure disorder, bipolar disorder, psychotic features, or clinically significant organic pathology
- Significant suicidal risk/ideation requiring immediate referral for more intensive treatment, or specific gesture in the last 6 months
- Current substance abuse or dependence requiring immediate referral to substance abuse program
- Acute medical problem requiring immediate inpatient treatment
- Need for referral to a partial hospitalization program
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 TherapyAlso: Cognitive Behavioral Therapy, CBT16 sessions of cognitive therapy administered weekly by a community mental health therapist | Behavioural | Cognitive Therapy |
| Supportive-Expressive Psychodynamic TherapyAlso: Psychodynamic Psychotherapy, Short Term Dynamic Therapy16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist | Behavioural | Dynamic Therapy |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 6 months
8 secondary outcomes
BASIS-24
Time frame: 6 months
Beck Depression Inventory - II (BDI-II)
Time frame: 6 months
Medical Outcomes Study 36-Item Short Form (SF-36)
Time frame: 6 months
Quality of Life Inventory (QOLI)
Time frame: 6 months
Ways of Responding (WOR)
Time frame: 2 months
Dysfunctional Attitudes Scale (DAS)
Time frame: 2 months
Psychological Distance Scaling Task (PDST)
Time frame: 2 months
Self-Understanding of Interpersonal Patterns Scale-Revised (SUIP-R)
Time frame: 2 months
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 2 May 2017.
- Derived from this study: PubMed 27487573Connolly Gibbons MB, Gallop R, Thompson D, Luther D, Crits-Christoph K, Jacobs J, Yin S, Crits-Christoph P. Comparative Effectiveness of Cognitive Therapy and Dynamic Psychotherapy for Major Depressive Disorder in a Community Mental Health Setting: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2016 Sep 1;73(9):904-11. doi: 10.1001/jamapsychiatry.2016.1720.
- Derived from this study: PubMed 25566391Connolly Gibbons MB, Mack R, Lee J, Gallop R, Thompson D, Burock D, Crits-Christoph P. Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial. BMC Psychol. 2014 Nov 11;2(1):47. doi: 10.1186/s40359-014-0047-y. eCollection 2014.
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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.
Mary Beth Gibbons, Ph.D. principal investigator
University of Pennsylvania
Paul Crits-Christoph, Ph.D. principal investigator
University of Pennsylvania
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 Therapy and Supportive-Expressive Psychodynamic Therapy in people with Major Depressive Disorder, run by University of Pennsylvania 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 3 inclusion and 5 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 2 May 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 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?
Hamilton Rating Scale for Depression (HAM-D) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207271, which also lists 2 linked publications.
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 2 May 2017.