Major Depressive DisorderPhase 3NCT00204152
Treatment for Chronic Depression
A Phase 3 study testing (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation in people with Major Depressive Disorder, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for short-term (16 weeks) of individual… Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2006
- Phase
- Phase 3
- 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 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- depressed male and female subjects between ages 18 to 58 years.
- current and primary diagnosis of DSM-IV Major Depressive Disorder (e.g., no lifetime history of bipolar I or II disorder, current anxiety disorders, or current substance dependence disorder (American Psychiatric Association, 1994).
- should also have upon study entry a score of 14 or higher (moderate depression) on the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960) and a score of 20 or higher (moderate depression) on the Beck Depression Inventory II (BDI-II; Beck et al., 1996a).
- background of high childhood trauma (70-item Childhood Trauma Questionnaire with a Total Score of 9 or higher).
- reasonably fluent in English to complete the evaluation.
Who cannot join
- history of bipolar affective disorder,
- history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
- current non-psychotic Axis I disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
- history of substance dependence in the past six months,
- antisocial, borderline, or schizotypal personality disorder,
- evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments,
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- current treatment with catecholaminergic antihypertensive medication, including reserpine, beta-blockers, clonidine, alphamethyldopa, etc. (diuretics, ACE inhibitors and calcium channel inhibitors will be allowed),
- clear indication of secondary gain (e.g., court ordered treatment or compensation issues),
- current suicide risk sufficient to preclude treatment on an outpatient basis (any patient scoring 3 or above on the suicide item on the HRSD or BDI must be cleared for study participation by the PI).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago, Department of Psychiatry
Chicago, Illinois, 60637
About this study
Official title: Treatment for Chronic Depression With Behavioral Interventions
The purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for short-term (16 weeks) of individual psychotherapy for adults with chronic major depression. The control condition is an individual workbook condition of Behavioral Activation. These psychotherapies focus on behavior activation, stress reduction and coping strategies to counter depressive symptoms.
Read the detailed description
Early-onset unipolar major depression is linked with considerable morbidity and mortality (Birmaher et al., 1996). The goal of this project is to test the efficacy of Behavioral Activation (BA; Jacobson et al., 2001) and an integrated version of Behavioral Activation (BA + Stress Inoculation Coping; BASIC) for the short-term psychotherapy of adults with chronic major depression (onset before age 18) and a history of early life stress before age 18. Exposure to stress during the developmental years has been linked with early-onset depression (Rao et al., 1996), a propensity to generate stress during the life span (Hammen et al., 1998), and a greater psychological sensitivity to stress as an adult (Post et al., 1992). And while incidence of early life stress is high among depressed adults, there are no behavioral treatments designed to address the unique needs of these individuals. We aim to develop a new treatment for a specific group of depressed patients, namely individuals who report early onset of depression and early life stress. We include the critical elements of behavioral activation and stress reduction strategies to address the avoidance, stress sensitivities, and coping deficits often observed in this population.
The specific aims are: 1) to determine if the addition of stress reduction strategies (packaged in BASIC) enhance the effects of BA, as indexed by the rate early remission; 2) to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination, as indexed by reduced rates of relapse by the 3-month follow-up; and, 3) to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills, and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills. Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA (control condition) using a randomized clinical trial design to distinguish between conditions. We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response. We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse.
- Conditions
- Major Depressive Disorder
- Being tested
- (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation
- Keywords
- Early onset depression, early adversity
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress InnoculationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of depression, measured by Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al., 1982; Keller et al., 1987), Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996a), and Hamilton Rating Scale for Depression.
Secondary outcomes (1)
Cognitive functioning, social/behavioral functioning, and stress regulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: PI left U of C
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 ChicagoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackie K Gollan, Ph.D., Principal investigator, The University of Chicago, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204152
- Sponsor's protocol ID
- 13166B
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996 Apr;64(2):295-304. doi: 10.1037//0022-006x.64.2.295.
PubMed 8871414
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Chronic Depression With Behavioral Interventions
- ClinicalTrials.gov ID
- NCT00204152
- Acronym / sponsor ID
- 13166B
- Conditions
- Major Depressive Disorder
- Keywords
- Early onset depression, early adversity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left U of C
- Enrolment
- 30 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Sep 2005 (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 purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for short-term (16 weeks) of individual psychotherapy for adults with chronic major depression. The control condition is an individual workbook condition of Behavioral Activation. These psychotherapies focus on behavior activation, stress reduction and coping strategies to counter depressive symptoms.
Detailed description
Early-onset unipolar major depression is linked with considerable morbidity and mortality (Birmaher et al., 1996). The goal of this project is to test the efficacy of Behavioral Activation (BA; Jacobson et al., 2001) and an integrated version of Behavioral Activation (BA + Stress Inoculation Coping; BASIC) for the short-term psychotherapy of adults with chronic major depression (onset before age 18) and a history of early life stress before age 18. Exposure to stress during the developmental years has been linked with early-onset depression (Rao et al., 1996), a propensity to generate stress during the life span (Hammen et al., 1998), and a greater psychological sensitivity to stress as an adult (Post et al., 1992). And while incidence of early life stress is high among depressed adults, there are no behavioral treatments designed to address the unique needs of these individuals. We aim to develop a new treatment for a specific group of depressed patients, namely individuals who report early onset of depression and early life stress. We include the critical elements of behavioral activation and stress reduction strategies to address the avoidance, stress sensitivities, and coping deficits often observed in this population.
The specific aims are: 1) to determine if the addition of stress reduction strategies (packaged in BASIC) enhance the effects of BA, as indexed by the rate early remission; 2) to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination, as indexed by reduced rates of relapse by the 3-month follow-up; and, 3) to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills, and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills. Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA (control condition) using a randomized clinical trial design to distinguish between conditions. We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response. We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- depressed male and female subjects between ages 18 to 58 years.
- current and primary diagnosis of DSM-IV Major Depressive Disorder (e.g., no lifetime history of bipolar I or II disorder, current anxiety disorders, or current substance dependence disorder (American Psychiatric Association, 1994).
- should also have upon study entry a score of 14 or higher (moderate depression) on the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960) and a score of 20 or higher (moderate depression) on the Beck Depression Inventory II (BDI-II; Beck et al., 1996a).
- background of high childhood trauma (70-item Childhood Trauma Questionnaire with a Total Score of 9 or higher).
- reasonably fluent in English to complete the evaluation.
Key exclusion criteria (9 listed)
- history of bipolar affective disorder,
- history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
- current non-psychotic Axis I disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
- history of substance dependence in the past six months,
- antisocial, borderline, or schizotypal personality 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 |
|---|---|---|
| (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation | Behavioural | – |
Primary outcome
severity of depression, measured by Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al., 1982; Keller et al., 1987), Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996a), and Hamilton Rating Scale for Depression.
1 secondary outcome
Cognitive functioning, social/behavioral functioning, and stress regulation.
Results and safety
The study was stopped early (reason given: PI left U of C). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Background: PubMed 8871414Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996 Apr;64(2):295-304. doi: 10.1037//0022-006x.64.2.295.
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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.
Jackie K Gollan, Ph.D. principal investigator
The University of Chicago, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation in people with Major Depressive Disorder, run by University of Chicago 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 9 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: stopped early, as of the sponsor's last update on 5 Sep 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left U of C). Results are not available in the source record.
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?
severity of depression, measured by Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al., 1982; Keller et al., 1987), Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996a), and Hamilton Rating Scale for Depression.. 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 NCT00204152, which also lists 1 linked publication.
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 5 Sep 2013.