DepressionNCT02602340
Neurocognitive Predictors of Behavioral Therapy Response in Depression
A study testing Behavioral Activation therapy in people with Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of depression that will predict the effectiveness of Behavioral Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2015to 3 Mar 2020
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-55
- All genders
- All races
- Eligibility as clinically significant depression will be determined by:
- Scoring greater than 9 on the Patient Health Questionnaire (PHQ-9) or meeting diagnostic criteria for Diagnostic and Statistical Manual (DSM-5) Major Depressive Disorder
- Self-report that they are interested in obtaining treatment for depression.
Show all 9Show fewer
- Through structured diagnostic interviews, it is determined that depressive symptoms are the primary disorder of concern.
- Able to provide written, informed consent
- Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures
Who cannot join
- Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- A history of drug abuse in the past 6 months, including alcohol, cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone. Current alcohol use will be ruled out using a breath test and urine testing will be used to rule out current use of other drugs of abuse.
- Has any of the following Diagnostic and Statistical Manual (DSM-5) disorders:
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Obsessive-Compulsive and Related Disorders
Show all 16Show fewer
- Anorexia or Bulimia Nervosa
- Substance use disorder within 6 months
- Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study.
- Active suicidal ideation with intent or plan
- Current use of a medication that could affect brain functioning (e.g., anxiolytics, antipsychotics, or mood stabilizers). However, participants reporting current use of prescribed antidepressants (selective serotonin reuptake inhibitors) will be included as long as the dose has been stable for 6 weeks prior to enrolling in the study.
- Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research
- Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day).
- MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy
- Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), blood draws, or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task).
- Non-correctable vision or hearing problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
This project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of depression that will predict the effectiveness of Behavioral Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include self-report questionnaires, computer-based and observational tasks, and interviews. Assessments will focus on how individuals process positive information (such as reward) and negative information (such as distressing images), as well as how people make decisions. These assessments will be conducted across 2-3 in-person sessions prior to beginning the treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will consist of 10, 90-minute weekly therapy sessions conducted in small groups.
Read the detailed description
Anxiety and mood disorders are the most prevalent class of mental health disorders, with lifetime prevalence estimated at 32% and 18%, respectively. These disorders have tremendous personal and socioeconomic impacts (cost >$1500 per-patient/year) due to days lost at work, increased health care utilization, and increased risk of mortality (e.g. cardiovascular disease). First-line treatments for depression include pharmacologic (e.g. selective serotonin reuptake inhibitors) and psychotherapeutic interventions (e.g. cognitive behavioral therapy and behavioral therapy). While both are superior to placebo treatments, only 40-60% of patients experience significant improvement and 15-25% of responders relapse within one year. Thus, long-lasting improvements are experienced by less than 50% of patients. This ineffectiveness has been moderately associated with symptom severity, illness duration, and comorbidity, but these findings do not provide any strategies for improving treatment effectiveness. The current study will seek to identify behavioral or cognitive-affective predictors that indicate how well a patient is responding to treatment so that interventions can be further individualized to more effectively treat refractory patients.
The aim of this study is to identify whether neural, biological, and behavioral responses related to the arbitration of conflicting avoidance and approach drives can predict behavior therapy response for depressed individuals. This aim will be accomplished using behavioral, functional magnetic resonance imaging (fMRI), and genetic analyses pre and post Behavioral Activation therapy. Research subjects will include treatment-seeking individuals with clinically significant symptoms of unipolar depression. Diagnosis will be assessed using structured clinical interviews. Anxious and depressive symptom severity, personality characteristics, and general functioning will be collected via self-report paper-and-pencil questionnaires. Objective measures of approach, avoidance, and conflict behavioral responses will be collected using computer-administered testing and related neural responsivity will be measured using fMRI. For exploratory aims, a blood draw will be collect pre and post-treatment to examine genetic factors that may predict response to behavior therapy. This research has the potential to identify neural and behavioral approach-avoidance characteristics that can help predict which patients are likely to respond to behavior therapy for depression (i.e., predictors of treatment effectiveness) and reveal targets for future treatment modifications.
Aim 1: Clarify the potential contribution of approach-avoidance behaviors and neural responses to depression symptom severity.
Hypothesis 1.1: Approach-related behaviors and conflict arbitration behavior will explain a significant amount of variance in depressive symptoms, above and beyond avoidance-related behavior.
Hypothesis 1.2: Activations within approach-related (i.e., striatum) and conflict arbitration (i.e., lateral PFC) neural circuitry will explain significant variance in depressive symptom severity above and beyond activations within avoidance-related (i.e., amygdala) neural circuitry. Specifically, the investigators expect increased levels of depression to relate to reduced striatal responsivity.
Aim 2: Identify approach-avoidance behaviors and neural responses that predict the effectiveness of behavioral activation therapy (BA) for depressed subjects.
Hypothesis 2.1: Approach-related behaviors and/or conflict arbitration behavior will help predict treatment response above and beyond avoidance-related behavior and baseline symptom severity. Specifically, the investigators expect that decreased reward sensitivity will predict nonresponse of depressed patients to BA.
Hypothesis 2.2: Approach-related and conflict arbitration neural circuitry will help to predict treatment response above and beyond activations within avoidance-related neural circuitry. Specifically, the investigators expect striatal responsivity to reward to predict response of depressed patients to BA.
Aim 3: Identify whether functional improvement with BA is associated with change in approach-avoidance behaviors and/or neural responses.
Hypothesis 3.1: The level of change in reward sensitivity will positively relate to the level of improvement in overall functioning with BA.
- Conditions
- Depression
- Being tested
- Behavioral Activation therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation therapyBehavioural
Behavioral Activation therapy
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation therapy | Experimental | Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen the depression. Receives: Behavioral: Behavioral Activation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale.
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
Measured: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Secondary outcomes (4)
Change in depression-related behaviors as assessed by the Behavioral Activation Depression Scale (BADS) Short Form.
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
Measured: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in anxiety symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale.
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
Measured: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in level of disability as measured by the Sheehan Disability Scale
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
Measured: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in depressive symptoms as measured by the Beck Depression Inventory - II.
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
Measured: Change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start6 Oct 2015
- Primary completion26 Sep 2019
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin L Aupperle, Ph.D., Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602340
- Sponsor's protocol ID
- 2015-006-01
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2015
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hollon SD, Stewart MO, Strunk D. Enduring effects for cognitive behavior therapy in the treatment of depression and anxiety. Annu Rev Psychol. 2006;57:285-315. doi: 10.1146/annurev.psych.57.102904.190044.
PubMed 16318597Hans E, Hiller W. Effectiveness of and dropout from outpatient cognitive behavioral therapy for adult unipolar depression: a meta-analysis of nonrandomized effectiveness studies. J Consult Clin Psychol. 2013 Feb;81(1):75-88. doi: 10.1037/a0031080.
PubMed 23379264Drevets WC. Neuroimaging and neuropathological studies of depression: implications for the cognitive-emotional features of mood disorders. Curr Opin Neurobiol. 2001 Apr;11(2):240-9. doi: 10.1016/s0959-4388(00)00203-8.
PubMed 11301246Siegle GJ, Thompson WK, Collier A, Berman SR, Feldmiller J, Thase ME, Friedman ES. Toward clinically useful neuroimaging in depression treatment: prognostic utility of subgenual cingulate activity for determining depression outcome in cognitive therapy across studies, scanners, and patient characteristics. Arch Gen Psychiatry. 2012 Sep;69(9):913-24. doi: 10.1001/archgenpsychiatry.2012.65.
PubMed 22945620Aupperle RL, Melrose AJ, Francisco A, Paulus MP, Stein MB. Neural substrates of approach-avoidance conflict decision-making. Hum Brain Mapp. 2015 Feb;36(2):449-62. doi: 10.1002/hbm.22639. Epub 2014 Sep 15.
PubMed 25224633Aupperle RL, Sullivan S, Melrose AJ, Paulus MP, Stein MB. A reverse translational approach to quantify approach-avoidance conflict in humans. Behav Brain Res. 2011 Dec 1;225(2):455-63. doi: 10.1016/j.bbr.2011.08.003. Epub 2011 Aug 6.
PubMed 21843556Addis, M. and C. Martell, Overcoming Depression One Step at a Time: The New Behavioral Activation Approach to Getting Your Life Back. 2004, Oakland, CA: New Harbinger Publications.
Martell, C.R., S. Dimidjian, and R. Herman-Dunn, Behavioral activation for depression: A clinician's guide. 2013: Guilford Press.
Dobson KS, Hollon SD, Dimidjian S, Schmaling KB, Kohlenberg RJ, Gallop RJ, Rizvi SL, Gollan JK, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the prevention of relapse and recurrence in major depression. J Consult Clin Psychol. 2008 Jun;76(3):468-77. doi: 10.1037/0022-006X.76.3.468.
PubMed 18540740
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Predictors of Behavioral Therapy Response in Depression
- ClinicalTrials.gov ID
- NCT02602340
- Acronym / sponsor ID
- 2015-006-01
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 11 Nov 2015 (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 project aims to identify brain and behavioral characteristics of individuals experiencing symptoms of depression that will predict the effectiveness of Behavioral Activation Therapy. Brain imaging aspects of the study will use functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Behavioral assessments will include self-report questionnaires, computer-based and observational tasks, and interviews. Assessments will focus on how individuals process positive information (such as reward) and negative information (such as distressing images), as well as how people make decisions. These assessments will be conducted across 2-3 in-person sessions prior to beginning the treatment, and will be repeated across 2-3 in-person sessions after completing treatment. A blood draw will also be conducted pre- and post- treatment. Behavior Activation therapy will consist of 10, 90-minute weekly therapy sessions conducted in small groups.
Detailed description
Anxiety and mood disorders are the most prevalent class of mental health disorders, with lifetime prevalence estimated at 32% and 18%, respectively. These disorders have tremendous personal and socioeconomic impacts (cost >$1500 per-patient/year) due to days lost at work, increased health care utilization, and increased risk of mortality (e.g. cardiovascular disease). First-line treatments for depression include pharmacologic (e.g. selective serotonin reuptake inhibitors) and psychotherapeutic interventions (e.g. cognitive behavioral therapy and behavioral therapy). While both are superior to placebo treatments, only 40-60% of patients experience significant improvement and 15-25% of responders relapse within one year. Thus, long-lasting improvements are experienced by less than 50% of patients. This ineffectiveness has been moderately associated with symptom severity, illness duration, and comorbidity, but these findings do not provide any strategies for improving treatment effectiveness. The current study will seek to identify behavioral or cognitive-affective predictors that indicate how well a patient is responding to treatment so that interventions can be further individualized to more effectively treat refractory patients.
The aim of this study is to identify whether neural, biological, and behavioral responses related to the arbitration of conflicting avoidance and approach drives can predict behavior therapy response for depressed individuals. This aim will be accomplished using behavioral, functional magnetic resonance imaging (fMRI), and genetic analyses pre and post Behavioral Activation therapy. Research subjects will include treatment-seeking individuals with clinically significant symptoms of unipolar depression. Diagnosis will be assessed using structured clinical interviews. Anxious and depressive symptom severity, personality characteristics, and general functioning will be collected via self-report paper-and-pencil questionnaires. Objective measures of approach, avoidance, and conflict behavioral responses will be collected using computer-administered testing and related neural responsivity will be measured using fMRI. For exploratory aims, a blood draw will be collect pre and post-treatment to examine genetic factors that may predict response to behavior therapy. This research has the potential to identify neural and behavioral approach-avoidance characteristics that can help predict which patients are likely to respond to behavior therapy for depression (i.e., predictors of treatment effectiveness) and reveal targets for future treatment modifications.
Aim 1: Clarify the potential contribution of approach-avoidance behaviors and neural responses to depression symptom severity.
Hypothesis 1.1: Approach-related behaviors and conflict arbitration behavior will explain a significant amount of variance in depressive symptoms, above and beyond avoidance-related behavior.
Hypothesis 1.2: Activations within approach-related (i.e., striatum) and conflict arbitration (i.e., lateral PFC) neural circuitry will explain significant variance in depressive symptom severity above and beyond activations within avoidance-related (i.e., amygdala) neural circuitry. Specifically, the investigators expect increased levels of depression to relate to reduced striatal responsivity.
Aim 2: Identify approach-avoidance behaviors and neural responses that predict the effectiveness of behavioral activation therapy (BA) for depressed subjects.
Hypothesis 2.1: Approach-related behaviors and/or conflict arbitration behavior will help predict treatment response above and beyond avoidance-related behavior and baseline symptom severity. Specifically, the investigators expect that decreased reward sensitivity will predict nonresponse of depressed patients to BA.
Hypothesis 2.2: Approach-related and conflict arbitration neural circuitry will help to predict treatment response above and beyond activations within avoidance-related neural circuitry. Specifically, the investigators expect striatal responsivity to reward to predict response of depressed patients to BA.
Aim 3: Identify whether functional improvement with BA is associated with change in approach-avoidance behaviors and/or neural responses.
Hypothesis 3.1: The level of change in reward sensitivity will positively relate to the level of improvement in overall functioning with BA.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation therapy | Experimental | Behavioral: Behavioral Activation therapyParticipants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen the depression. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-55
- All genders
- All races
- Eligibility as clinically significant depression will be determined by:
- Able to provide written, informed consent
Key exclusion criteria (16 listed)
- Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- A history of drug abuse in the past 6 months, including alcohol, cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone. Current alcohol use will be ruled out using a breath test and urine testing will be used to rule out current use of other drugs of abuse.
- Has any of the following Diagnostic and Statistical Manual (DSM-5) disorders:
- Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study.
- Active suicidal ideation with intent or plan
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 |
|---|---|---|
| Behavioral Activation therapyBehavioral Activation therapy | Behavioural | Behavioral Activation therapy |
Primary outcome
Change in depressive symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale.
Time frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment.
4 secondary outcomes
Change in depression-related behaviors as assessed by the Behavioral Activation Depression Scale (BADS) Short Form.
Time frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in anxiety symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale.
Time frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in level of disability as measured by the Sheehan Disability Scale
Time frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
Change in depressive symptoms as measured by the Beck Depression Inventory - II.
Time frame: Change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment
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 25 Nov 2020.
- Background: PubMed 16318597Hollon SD, Stewart MO, Strunk D. Enduring effects for cognitive behavior therapy in the treatment of depression and anxiety. Annu Rev Psychol. 2006;57:285-315. doi: 10.1146/annurev.psych.57.102904.190044.
- Background: PubMed 23379264Hans E, Hiller W. Effectiveness of and dropout from outpatient cognitive behavioral therapy for adult unipolar depression: a meta-analysis of nonrandomized effectiveness studies. J Consult Clin Psychol. 2013 Feb;81(1):75-88. doi: 10.1037/a0031080.
- Background: PubMed 11301246Drevets WC. Neuroimaging and neuropathological studies of depression: implications for the cognitive-emotional features of mood disorders. Curr Opin Neurobiol. 2001 Apr;11(2):240-9. doi: 10.1016/s0959-4388(00)00203-8.
- Background: PubMed 22945620Siegle GJ, Thompson WK, Collier A, Berman SR, Feldmiller J, Thase ME, Friedman ES. Toward clinically useful neuroimaging in depression treatment: prognostic utility of subgenual cingulate activity for determining depression outcome in cognitive therapy across studies, scanners, and patient characteristics. Arch Gen Psychiatry. 2012 Sep;69(9):913-24. doi: 10.1001/archgenpsychiatry.2012.65.
- Background: PubMed 25224633Aupperle RL, Melrose AJ, Francisco A, Paulus MP, Stein MB. Neural substrates of approach-avoidance conflict decision-making. Hum Brain Mapp. 2015 Feb;36(2):449-62. doi: 10.1002/hbm.22639. Epub 2014 Sep 15.
- Background: PubMed 21843556Aupperle RL, Sullivan S, Melrose AJ, Paulus MP, Stein MB. A reverse translational approach to quantify approach-avoidance conflict in humans. Behav Brain Res. 2011 Dec 1;225(2):455-63. doi: 10.1016/j.bbr.2011.08.003. Epub 2011 Aug 6.
- BackgroundAddis, M. and C. Martell, Overcoming Depression One Step at a Time: The New Behavioral Activation Approach to Getting Your Life Back. 2004, Oakland, CA: New Harbinger Publications.
- BackgroundMartell, C.R., S. Dimidjian, and R. Herman-Dunn, Behavioral activation for depression: A clinician's guide. 2013: Guilford Press.
- Background: PubMed 18540740Dobson KS, Hollon SD, Dimidjian S, Schmaling KB, Kohlenberg RJ, Gallop RJ, Rizvi SL, Gollan JK, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the prevention of relapse and recurrence in major depression. J Consult Clin Psychol. 2008 Jun;76(3):468-77. doi: 10.1037/0022-006X.76.3.468.
- Individual participant dataSharing planned: Undecided
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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.
Robin L Aupperle, Ph.D. principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation therapy in people with Depression, run by Laureate Institute for Brain Research, Inc. 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 9 inclusion and 16 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 25 Nov 2020. 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?
Change in depressive symptoms as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale. (time frame: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment). 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 NCT02602340, which also lists 9 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 25 Nov 2020.