Depressive DisorderNCT01528748
Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence
An observational study of Depressive Disorder and Major Depressive Disorder, run by University of Virginia at 1 site in United States.
Trial summary
This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Depressive Disorder, Major Depressive Disorder, Dysthymic Disorder
- What is being tested?
- Cognitive Behavioral Analysis System of Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2018
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited via a community sample.
Who may be able to join
- Clinical diagnosis of a current major depressive disorder (e.g., Major Depression, Dysthymic Disorder) for a minimum of two years
- Clinical diagnosis of alcohol dependence during the last thirty days
- Interest in changing one's drinking and alleviating depressive symptoms
Who cannot join
- Please call study site for additional information
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Addiction Research & Education (UVa CARE)
Charlottesville, Virginia, 22911
About this study
This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent.
Read the detailed description
This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent. Participants will receive a 20-session course of CBASP psychotherapy over a period of 21 weeks and will be assessed for severity of pretreatment psychological abuse and trauma as well as pre and posttreatment interpersonal functioning. Two primary hypotheses are to be tested: 1) demonstrate that CBASP is effective in reducing depressive symptoms (Hamilton Rating Scale for Depression-24 ratings) and alcohol consumption (drinks per drinking day) in this chronically depressed alcohol dependent cohort when posttreatment ratings are compared to pretreatment levels; and 2) demonstrate that acquisition of feeling safe with the therapist and acquisition of the ability to perceive the interpersonal consequences of one's behavior will significantly increase from pre to posttreatment levels and will be associated with reductions in drinking and depressive symptoms.
- Conditions
- Depressive Disorder, Major Depressive Disorder, Dysthymic Disorder, Alcohol-Related Disorders, Alcoholism
- Being tested
- Cognitive Behavioral Analysis System of Psychotherapy
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Dysthymic Disorder, Alcohol-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Analysis System of PsychotherapyBehavioural
Also called CBASP
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a behavioral intervention that addresses the unique behavioral characteristics of chronically depressed individuals, most of which are highly relevant for alcoholics as well. CBASP has a structured, individualized, and collaborative (patient and clinician) design. The intervention emphasizes teaching effective coping strategies and employing motivational, cognitive, behavioral, and interpersonal techniques. Individual therapy (1 hour) sessions occur on a weekly basis for a total of 20 sessions over a period of 21 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chronically Depressed, Alcohol Dependent | Participants who have been formally diagnosed with a clinical diagnosis of Chronic Depression and Alcohol Dependence. Receives: Behavioral: Cognitive Behavioral Analysis System of Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Rating
Change in depression rating scale over time.
Measured: Baseline and 20 weeks
Drinking behavior
Change in number of drinks consumed per day over time.
Measured: Baseline and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2015
- Study completionJul 2018
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 Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Kim Penberthy, University of Virginia
- Investigators
- Jennifer K. Penberthy, Ph.D., Principal investigator, University of Virginia, School of Medicine, Department of Psychiatry & Neurobehavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528748
- Sponsor's protocol ID
- 15599
- Status last verified
- Apr 2019
- First submitted
- 4 Feb 2012
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.
PubMed 12858425McCullough, Jr., JP. (2001). Skills Training Manual for Diagnosis and Treating Chronic Depression: Cognitive Behavioral Analysis System of Psychotherapy (CBASP). New York: Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of CBASP for Individuals With Co-occurring Chronic Depression and Alcohol Dependence
- ClinicalTrials.gov ID
- NCT01528748
- Acronym / sponsor ID
- 15599
- Conditions
- Depressive Disorder, Major Depressive Disorder, Dysthymic Disorder, Alcohol-Related Disorders, Alcoholism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Feb 2012 (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.
This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent.
Detailed description
This study examines the effectiveness of Cognitive Behavioral Analysis System of Psychotherapy (CBASP) in reducing both alcohol consumption and depressive symptoms in adults who are chronically depressed and alcohol dependent. Participants will receive a 20-session course of CBASP psychotherapy over a period of 21 weeks and will be assessed for severity of pretreatment psychological abuse and trauma as well as pre and posttreatment interpersonal functioning. Two primary hypotheses are to be tested: 1) demonstrate that CBASP is effective in reducing depressive symptoms (Hamilton Rating Scale for Depression-24 ratings) and alcohol consumption (drinks per drinking day) in this chronically depressed alcohol dependent cohort when posttreatment ratings are compared to pretreatment levels; and 2) demonstrate that acquisition of feeling safe with the therapist and acquisition of the ability to perceive the interpersonal consequences of one's behavior will significantly increase from pre to posttreatment levels and will be associated with reductions in drinking and depressive symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronically Depressed, Alcohol Dependent | – | Behavioral: Cognitive Behavioral Analysis System of PsychotherapyParticipants who have been formally diagnosed with a clinical diagnosis of Chronic Depression and Alcohol Dependence. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited via a community sample.
Key inclusion criteria (3 listed)
- Clinical diagnosis of a current major depressive disorder (e.g., Major Depression, Dysthymic Disorder) for a minimum of two years
- Clinical diagnosis of alcohol dependence during the last thirty days
- Interest in changing one's drinking and alleviating depressive symptoms
Key exclusion criteria (1 listed)
- Please call study site for additional information
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 Behavioral Analysis System of PsychotherapyAlso: CBASPCognitive Behavioral Analysis System of Psychotherapy (CBASP) is a behavioral intervention that addresses the unique behavioral characteristics of chronically depressed individuals, most of which are highly relevant for alcoholics as well. CBASP has a structured, individualized, and collaborative (patient and clinician) design. The intervention emphasizes teaching effective coping strategies and employing motivational, cognitive, behavioral, and interpersonal techniques. Individual therapy (1 hour) sessions occur on a weekly basis for a total of 20 sessions over a period of 21 weeks. | Behavioural | Chronically Depressed, Alcohol Dependent |
Primary outcome
Depression Rating
Time frame: Baseline and 20 weeks
Change in depression rating scale over time.
Drinking behavior
Time frame: Baseline and 20 weeks
Change in number of drinks consumed per day over time.
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 Apr 2019.
- Background: PubMed 12858425McCullough JP Jr. Treatment for chronic depression using Cognitive Behavioral Analysis System of Psychotherapy (CBASP). J Clin Psychol. 2003 Aug;59(8):833-46. doi: 10.1002/jclp.10176.
- BackgroundMcCullough, Jr., JP. (2001). Skills Training Manual for Diagnosis and Treating Chronic Depression: Cognitive Behavioral Analysis System of Psychotherapy (CBASP). New York: Guilford Press.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Jennifer K. Penberthy, Ph.D. principal investigator
University of Virginia, School of Medicine, Department of Psychiatry & Neurobehavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Major Depressive Disorder, run by University of Virginia 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 1 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 Apr 2019. 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?
Depression Rating (time frame: Baseline and 20 weeks). 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?
On the ClinicalTrials.gov record for NCT01528748, 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 17 Apr 2019.