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Mechanisms of Behavioral Activation (BA)

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation Therapy
Baseline assessment procedures
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Behavioral Activation, fMRI

Eligibility Criteria

15 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female adolescents ages 15-17;
  • current MDD diagnosis as determined by K-SADS-PL,
  • CDRS-R raw score > 45 (T-score > 65) at baseline;
  • estimated full scale IQ > 80 as determined by the WISC;
  • able to receive outpatient care;
  • willing to not partake in other psychosocial treatments;
  • not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD.
  • Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study.
  • Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score < 52).

Exclusion Criteria:

  • Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS;
  • current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders;
  • taking psychotropic medications prior to entry;
  • estimated IQ < 80; alcohol/drug dependence or abuse within the last 3 months;
  • potential/confirmed neurological disorder or epilepsy;
  • claustrophobia;
  • presence of a medical condition that precludes fMRI;
  • endorsement of imminent and serious suicidality;
  • medical conditions that take precedence over the presence of MDD;
  • pregnancy;
  • substance use (excluding nicotine) within two weeks of the fMRI scan;
  • left-handedness;
  • nicotine use within 3 hours of the fMRI scan;
  • history of traumatic brain injury or of being unconscious for more than 30 minutes;
  • a stimulant regime for ADHD which has changed within 30 days of the fMRI scan.
  • Non-compliance (i.e. <70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.

Sites / Locations

  • Emory UniversityRecruiting
  • Facility for Education and Research in Neuroscience (FERN)Recruiting
  • Child and Adolescent Mood Program (CAMP)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDD patients

Arm Description

Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.

Outcomes

Primary Outcome Measures

Change in Diagnostic Interview Status (CDRS-R) total score from baseline
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)
The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (<4).

Secondary Outcome Measures

Change in Beck Depression Inventory (BDI-II)
BDI-II is a 21-self report assessment of the level of depressive symptoms over 2-week period. The minimum and maximum values for the BDI-II are (0-63). The higher the scores, the greater the severity of depression.

Full Information

First Posted
September 15, 2022
Last Updated
February 15, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05548244
Brief Title
Mechanisms of Behavioral Activation (BA)
Official Title
Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.
Detailed Description
The primary aim of this study is to investigate the behavioral and neurobiological factors predicting response to Behavior Activation (BA), a psychosocial treatment for Major Depressive Disorder (MDD), in adolescents. The recruitment age pool will be adolescents ages 15-17. The investigators plan to recruit 40 healthy controls and 96 treatment-seeking adolescents for an overall sample of ~136 participants, Individuals who reach the age of majority (18) during the study will be re-consented as adults and allowed to continue participating in the study. A healthy control group will be included to assess stability in behavioral and neuroimaging measures over the course of participation in the study. The fMRI scan schedule will include three task-based sessions (baseline, after session 7, and after endpoint) and two (sessions 3 & 9). "behavioral-scheduling-in-the-scanner" sessions Primary results will focus on symptom change within patients and their association to measures of low motivation and threat avoidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Behavioral Activation, fMRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MDD patients
Arm Type
Experimental
Arm Description
Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy
Other Intervention Name(s)
BA Therapy
Intervention Description
Participants will be seen for a maximum of 16 sessions of therapy focused on increasing rewarding behaviors (16 individual therapy sessions of 1-hour, 2 of which include the BSIS component) over 16 weeks. BA intervention includes monthly booster sessions offered throughout 6-month follow up. If needed, two extra sessions will be allowed during treatment.
Intervention Type
Behavioral
Intervention Name(s)
Baseline assessment procedures
Intervention Description
Completion of the K-SADS and CDRS-R to assess MDD, and the Wechsler Intelligence Scale for Children-Short Form to assess IQ.
Primary Outcome Measure Information:
Title
Change in Diagnostic Interview Status (CDRS-R) total score from baseline
Description
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.
Time Frame
Baseline, week 16 post intervention
Title
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)
Description
The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (<4).
Time Frame
Baseline, week 16 post intervention
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory (BDI-II)
Description
BDI-II is a 21-self report assessment of the level of depressive symptoms over 2-week period. The minimum and maximum values for the BDI-II are (0-63). The higher the scores, the greater the severity of depression.
Time Frame
Baseline, weekly therapy visits 1-16 post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female adolescents ages 15-17; current MDD diagnosis as determined by K-SADS-PL, CDRS-R raw score > 45 (T-score > 65) at baseline; estimated full scale IQ > 80 as determined by the WISC; able to receive outpatient care; willing to not partake in other psychosocial treatments; not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD. Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study. Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score < 52). Exclusion Criteria: Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS; current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders; taking psychotropic medications prior to entry; estimated IQ < 80; alcohol/drug dependence or abuse within the last 3 months; potential/confirmed neurological disorder or epilepsy; claustrophobia; presence of a medical condition that precludes fMRI; endorsement of imminent and serious suicidality; medical conditions that take precedence over the presence of MDD; pregnancy; substance use (excluding nicotine) within two weeks of the fMRI scan; left-handedness; nicotine use within 3 hours of the fMRI scan; history of traumatic brain injury or of being unconscious for more than 30 minutes; a stimulant regime for ADHD which has changed within 30 days of the fMRI scan. Non-compliance (i.e. <70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wade E Craighead, PhD
Phone
4047128383
Email
ecraigh@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Treadway, PhD
Email
mtreadway@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wade E Craighead, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wade E Craighead, PhD
Email
ecraigh@emory.edu
Facility Name
Facility for Education and Research in Neuroscience (FERN)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Treadway, PhD
Email
mtreadway@emory.edu
Facility Name
Child and Adolescent Mood Program (CAMP)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wade E Craighead, PhD
Email
ecraigh@Emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data (including access and additional documents) will be shared through the NIMH NDA and in accordance with NIMH NDA data-sharing policy.
IPD Sharing Time Frame
As soon as possible after data collection.
IPD Sharing Access Criteria
In accordance with NIMH NDA data-sharing policy.

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Mechanisms of Behavioral Activation (BA)

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