Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder

An observational study of Depression, run by Northwestern University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment. Read more about this study

Who is it for?: Ages 18 to 72 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Behavioral Activation
Type of treatment: Injection or infusion, Lifestyle or therapy programme
How many people: 77 participants
Where: No sites listed yet
Study dates: May 2009to Apr 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 72 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Participants are drawn from the general population through on-line advertisements for the study.

Who may be able to join

Healthy participants should have no lifetime history of psychiatric disorder
Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV

Who cannot join

History of bipolar affective disorder
History of psychosis
Current non-psychotic Axis I disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study
History of substance dependence within the past 6 months
Antisocial, borderline, schizotypal, or schizoid personality disorders
Evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments

Show all 12Show fewer

Current treatment with catecholaminergic antihypertensive medication, such as reserpine, beta-blockers, clonidine, and alphamethyldopa
Current use of antidepressant medication
Clear indication of secondary gain
Current suicide risk sufficient to preclude treatment on an outpatient basis
Severe, unstable concurrent psychiatric conditions likely to require hospitalization within 6 months of study entry
Already receiving a targeted psychotherapy aimed at depression

About this study

Official title: Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD

This study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment.

Read the detailed description

Major depressive disorder is a serious form of depression that may be treated with psychotherapy. However, up to 40% of adults with depression do not show reduced symptoms when treated with cognitive therapy or behavioral activation (BA), two common forms of psychotherapy. Certain indicators are generally linked with a successful outcome of psychotherapy-demographic and clinical characteristics, comorbidity, and treatment adherence-but no factors reliably predict outcomes of psychotherapy in individuals. This study will test whether two characteristics related to the way people process emotions, affective asymmetry and affective reactivity, can predict whether people with depression will improve with BA therapy.

Both depressed and healthy participants will be recruited for this study. Participation in this study will last 31 weeks. All participants will complete baseline assessments at Weeks 1 and 2. Depressed participants will then begin receiving 16 weekly sessions of BA therapy. All participants will be assessed again after 8, 16, 17, and 28 weeks. Assessments will include the following: a urine toxicology screening; interviews on mental and physical health, family and childhood experiences, and current mood and functioning; computer tasks; recordings of electroencephalography (EEG) activity; recordings of reaction to a startle probe; recordings of electromyography (EMG) activity; recordings of electrodermal activity (EDA); and measurement of blood pressure.

Conditions: Depression
Being tested: Behavioral Activation
Keywords: Major Depressive Disorder, EEG, Negativity bias
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral ActivationBehavioural
Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).

Study groups in NCT00909220
Study group	Role	What they receive
Current Major Depressive Disorder		Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986) were enrolled into a treatment study at Northwestern University's Feinberg School of Medicine in Chicago, Illinois. This group will receive Behavioral Activation psychotherapy. Receives: Behavioral: Behavioral Activation
Healthy Participants		Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were tracked prospectively, naturalistically, for 16 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
The Inventory of Depressive Symptomatology-Clinician Rated measure (IDS-C; Rush, Giles, Schlesser, Fulton, Weissenburger, Burns, 1986; Rush, Carmody, \& Reimitz, 2000; Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) is a 30-item measure that reflects the presence and severity of DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score. Scores range from 0 (minimum score, reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Scores between 0-11 are interpreted as 'no depression'; scores between 12-23 are interpreted as 'mild severity'; scores between 24-36 are interpreted as 'severe'; and total scores between '47-84' are interpreted as 'very severe'.
Measured: Week 16
Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
The Inventory of Depressive Symptomatology, Self-Rated measure (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity completed by the participant. The item scores on this scale are summed to create a total score (range from 0 (no symptoms) to 84 (highest severity). The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-13 is interpreted as 'no depression', scores between 14-25 are interpreted as 'mild severity'; total scores between 26-48 are interpreted as 'severe', and total scores between '49-84' are interpreted as 'very severe'.
Measured: Week 16
Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment
Frontal EEG asymmetry scores were calculated over the midfrontal sites, subtracting the natural log of the alpha power of the electrode in the left hemisphere (F3 or F7) from that of the right frontal electrode (F4 or F8), creating one summary alpha asymmetry variable. The absolute value of this difference score was taken. Using the natural log transformation is used in EEG asymmetry research as EEG power appears to be positively skewed. A higher score thus reflected greater relative left versus right frontal activation (e.g., relatively higher right alpha activity).
Measured: Week 0
A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).
The negativity bias, characterized as the tendency to evaluate unpleasant versus pleasant information as more important, was measured using a computer task. Sitting in front of the computer, participants viewed emotionally evocative images and assigned their evaluations of how the intensity of these emotional images using a grid. The grid is comprised of a matrix, with 5 points on the horizontal axis representing the positivity seen in the image (0=not at all, 4 = extremely positive) by 5 points on a vertical axis representing the negativity seen in the image (0=not at all, 4 = extremely negative) matrix. The dimensional variable, negativity bias, is calculated as the difference in the mean ratings of very unpleasant images minutes the positive ratings of the very pleasant images. The Inventory of Depressive Symptomatology, Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity provided by the participant.
Measured: Weeks 0-16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Apr 2012

First posted27 May 2009 (estimated)
Study startMay 2009
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Case-control
Time perspective: Prospective
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909220
Sponsor's protocol ID: R21MH082133
Other IDs: R21MH082133
Status last verified: Mar 2018
First submitted: 26 May 2009
Last updated: 17 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Request PI (JGollan) for de-identified data at j-gollan@northwestern.edu

Publications

Gollan JK, Hoxha D, Chihade D, Pflieger ME, Rosebrock L, Cacioppo J. Frontal alpha EEG asymmetry before and after behavioral activation treatment for depression. Biol Psychol. 2014 May;99:198-208. doi: 10.1016/j.biopsycho.2014.03.003. Epub 2014 Mar 24.
PubMed 24674708
Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. Twice the negativity bias and half the positivity offset: Evaluative responses to emotional information in depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:166-170. doi: 10.1016/j.jbtep.2015.09.005. Epub 2015 Sep 26.
PubMed 26434794
Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. The negativity bias predicts response rate to Behavioral Activation for depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:171-178. doi: 10.1016/j.jbtep.2015.09.011. Epub 2015 Sep 28.
PubMed 26433700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD
ClinicalTrials.gov ID: NCT00909220
Acronym / sponsor ID: R21MH082133
Conditions: Depression
Keywords: Major Depressive Disorder, EEG, Negativity bias
Study type: Observational
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), University of Chicago, Dartmouth College
Study start: May 2009
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 27 May 2009 (estimated)
Results: Posted 16 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Current Major Depressive Disorder	–	Behavioral: Behavioral ActivationForty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986) were enrolled into a treatment study at Northwestern University's Feinberg School of Medicine in Chicago, Illinois. This group will receive Behavioral Activation psychotherapy.
Healthy Participants	–	–Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were tracked prospectively, naturalistically, for 16 weeks.

Who may qualify

Ages: 18 to 72 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Participants are drawn from the general population through on-line advertisements for the study.

Key inclusion criteria (2 listed)

Healthy participants should have no lifetime history of psychiatric disorder
Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV

Key exclusion criteria (12 listed)

History of bipolar affective disorder
History of psychosis
Current non-psychotic Axis I disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study
History of substance dependence within the past 6 months
Antisocial, borderline, schizotypal, or schizoid personality disorders

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 ActivationBehavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).	Behavioural	Current Major Depressive Disorder

Primary outcome

Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
Time frame: Week 16
The Inventory of Depressive Symptomatology-Clinician Rated measure (IDS-C; Rush, Giles, Schlesser, Fulton, Weissenburger, Burns, 1986; Rush, Carmody, \& Reimitz, 2000; Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) is a 30-item measure that reflects the presence and severity of DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score. Scores range from 0 (minimum score, reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Scores between 0-11 are interpreted as 'no depression'; scores between 12-23 are interpreted as 'mild severity'; scores between 24-36 are interpreted as 'severe'; and total scores between '47-84' are interpreted as 'very severe'.
Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
Time frame: Week 16
The Inventory of Depressive Symptomatology, Self-Rated measure (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity completed by the participant. The item scores on this scale are summed to create a total score (range from 0 (no symptoms) to 84 (highest severity). The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-13 is interpreted as 'no depression', scores between 14-25 are interpreted as 'mild severity'; total scores between 26-48 are interpreted as 'severe', and total scores between '49-84' are interpreted as 'very severe'.
Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment
Time frame: Week 0
Frontal EEG asymmetry scores were calculated over the midfrontal sites, subtracting the natural log of the alpha power of the electrode in the left hemisphere (F3 or F7) from that of the right frontal electrode (F4 or F8), creating one summary alpha asymmetry variable. The absolute value of this difference score was taken. Using the natural log transformation is used in EEG asymmetry research as EEG power appears to be positively skewed. A higher score thus reflected greater relative left versus right frontal activation (e.g., relatively higher right alpha activity).
A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).
Time frame: Weeks 0-16
The negativity bias, characterized as the tendency to evaluate unpleasant versus pleasant information as more important, was measured using a computer task. Sitting in front of the computer, participants viewed emotionally evocative images and assigned their evaluations of how the intensity of these emotional images using a grid. The grid is comprised of a matrix, with 5 points on the horizontal axis representing the positivity seen in the image (0=not at all, 4 = extremely positive) by 5 points on a vertical axis representing the negativity seen in the image (0=not at all, 4 = extremely negative) matrix. The dimensional variable, negativity bias, is calculated as the difference in the mean ratings of very unpleasant images minutes the positive ratings of the very pleasant images. The Inventory of Depressive Symptomatology, Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity provided by the participant.

Results and safety

Results posted to the registry on 16 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Current Major Depressive Disorder	41	41
Healthy Participants	36	36

Primary outcome: Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.

Time frame: Week 16. Mean (Standard Deviation). Unit: units on a scale

Measure	Current Major Depressive Disorder n = 41	Healthy Participants n = 36
Value	14.1 (10.1)	2.7 (2.7)

Current Major Depressive Disorder vs Healthy Participants: Mean Difference (Final Values): 0.42 (95% CI 0.27 to 0.49), p = 0.05, ANCOVA

Population analysed: Intent to treat sample.

Primary outcome: Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.

Time frame: Week 16. Mean (Standard Deviation). Unit: units on a scale

Measure	Current Major Depressive Disorder n = 41	Healthy Participants n = 36
Value	16.9 (13.4)	3.0 (4.6)

Current Major Depressive Disorder vs Healthy Participants: Mean Difference (Final Values): 0.39 (95% CI 0.31 to 0.59), p <0.05, ANCOVA

Population analysed: Intent to treat sample.

Primary outcome: Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment

Time frame: Week 0. Mean (Standard Error). Unit: Alpha power

Measure	Current Major Depressive Disorder n = 37	Healthy Participants n = 35
Value	0.43 (0.12)	0.16 (0.05)

Current Major Depressive Disorder vs Healthy Participants: beta: 0.43, p = .02, Regression, Linear

Primary outcome: A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).

Time frame: Weeks 0-16. Geometric least squares mean (Standard Error). Unit: slope

Measure	Current Major Depressive Disorder n = 41
Value	-3.43 (0.75)

Current Major Depressive Disorder: Slope: 2.58 (95% CI 1.22 to 2.77), p <0.05, Regression, Logistic

Population analysed: First level units were 'weeks in BA treatment', with participants limited to those diagnosed with MDD and who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'MDD subjects entering treatment' (n = 41)

Adverse events

Time frame: Serious and Other (Not including Serious) Adverse Events were not collected/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Current Major Depressive Disorder	0 of 0	0 of 0	Not reported
Healthy Participants	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): We enrolled adults who were medication-free, which may limit the generalizability of these results to those individuals who rely on pharmacotherapy and somatic therapies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24674708Gollan JK, Hoxha D, Chihade D, Pflieger ME, Rosebrock L, Cacioppo J. Frontal alpha EEG asymmetry before and after behavioral activation treatment for depression. Biol Psychol. 2014 May;99:198-208. doi: 10.1016/j.biopsycho.2014.03.003. Epub 2014 Mar 24.
Results publication: PubMed 26434794Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. Twice the negativity bias and half the positivity offset: Evaluative responses to emotional information in depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:166-170. doi: 10.1016/j.jbtep.2015.09.005. Epub 2015 Sep 26.
Results publication: PubMed 26433700Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. The negativity bias predicts response rate to Behavioral Activation for depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:171-178. doi: 10.1016/j.jbtep.2015.09.011. Epub 2015 Sep 28.
Individual participant dataSharing planned: Yes. Request PI (JGollan) for de-identified data at j-gollan@northwestern.edu

Related trials for Depression

Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms

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.

Jacqueline K. Gollan, PhD principal investigator

Northwestern University

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by Northwestern University.

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 2 inclusion and 12 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 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity. (time frame: Week 16). The study lists 4 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 NCT00909220, which also lists 3 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 2018.