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The Neurobiology of Approach Avoidance Training in Depression (ACTIV8)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Approach-positive AAT
Control AAT
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18-55
  • Principal psychiatric diagnosis of major depressive disorder
  • Patient Health Questionnaire - 9 item score ≥ 10
  • Ability to read and speak English sufficiently to complete study procedures

Exclusion Criteria:

  • History of psychosis, mania, or substance dependence
  • Current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, sever coronary artery disease, sever peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness > 30 minutes
  • Current use of the following medications: antidepressants, benxodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide)
  • Caffeine intake > 10 cups/day or recent significant changes in consumption
  • MRI exclusions, including claustrophobia, 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 metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue or face rings.
  • Concurrent psychosocial treatment: Participants completing ongoing psychosocial treatment will be required to meet a 12-week stability criteria so that symptom changes as a result of other psychosocial treatments are not confounded with changes due to the research.
  • Inability to complete the initial assessment battery or behavioral training sessions.
  • Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation). These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.

Sites / Locations

  • University of California, San Diego; Psychiatry Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Approach-positive AAT

Control AAT

Arm Description

Computerized AAT procedure designed to increase automatic approach responses for positive social cues.

Computerized AAT procedure in which there is no contingency between arm movement and positive social cues.

Outcomes

Primary Outcome Measures

Change from pre-training in blood oxygen level dependent (BOLD) response in the striatum, amygdala, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI) during reward trials on the Social Incentive Delay (SID) task.
Change from pre- to post-training in neural activation during social reward processing.

Secondary Outcome Measures

Response bias to rewards on the Probabilistic Reward Task (PRT)
Post-training (20 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) reward response bias on the PRT.
Response to social interaction task
Post-training (30 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) behavioral and emotional response to the social interaction task.

Full Information

First Posted
December 24, 2014
Last Updated
August 31, 2017
Sponsor
University of California, San Diego
Collaborators
Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02330744
Brief Title
The Neurobiology of Approach Avoidance Training in Depression
Acronym
ACTIV8
Official Title
The Neurobiology of Approach Avoidance Training in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the effects of a computerized approach/avoidance training (AAT) procedure on behavioral, affective, and brain mechanisms that are important for reward sensitivity and well-being in individuals diagnosed with major depression. The training procedure is designed to modify automatic approach responses for positive social stimuli. The primary aim is to determine the effects of approach/avoidance training on the functioning of brain systems during reward processing in individuals diagnosed with major depression. A secondary aim will determine whether brain activation patterns following approach/avoidance training predict subsequent affective and behavioral responses during reward processing. An exploratory aim will test whether completing the approach/avoidance training procedure in combination with a brief computer-delivered behavioral activation program for depression will produce larger changes in depression symptoms, positive emotions, and social relationship functioning from pre- to post-intervention compared to the control training procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Approach-positive AAT
Arm Type
Experimental
Arm Description
Computerized AAT procedure designed to increase automatic approach responses for positive social cues.
Arm Title
Control AAT
Arm Type
Placebo Comparator
Arm Description
Computerized AAT procedure in which there is no contingency between arm movement and positive social cues.
Intervention Type
Behavioral
Intervention Name(s)
Approach-positive AAT
Intervention Description
One session of approach-positive AAT (Aim 1 and 2) followed by 4 sessions of approach-positive AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
Intervention Type
Behavioral
Intervention Name(s)
Control AAT
Intervention Description
One session of control-AAT (Aim 1 and 2) followed by 4 sessions of control-AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
Primary Outcome Measure Information:
Title
Change from pre-training in blood oxygen level dependent (BOLD) response in the striatum, amygdala, and medial prefrontal cortex, as measured with functional magnetic resonance imaging (fMRI) during reward trials on the Social Incentive Delay (SID) task.
Description
Change from pre- to post-training in neural activation during social reward processing.
Time Frame
Post-training (5 minutes)
Secondary Outcome Measure Information:
Title
Response bias to rewards on the Probabilistic Reward Task (PRT)
Description
Post-training (20 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) reward response bias on the PRT.
Time Frame
Post-training (20 minutes) and 1 month
Title
Response to social interaction task
Description
Post-training (30 minutes; Aim 2) and post-AAT plus brief behavioral activation treatment (1 month; Aim 3) behavioral and emotional response to the social interaction task.
Time Frame
Post-training (30 minutes) and 1 month
Other Pre-specified Outcome Measures:
Title
Change from baseline in depression (Patient Health Questionnaire-9; Beck Depression Inventory II, composite)
Description
Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in symptoms of depression.
Time Frame
1 month
Title
Change from baseline in positive affect (Positive and Negative Affect Schedule)
Description
Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in positive affect.
Time Frame
1 month
Title
Change from baseline in social relationship functioning (Social Connectedness Scale - Revised; Interpersonal Outcomes Scale)
Description
Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in social relationship functioning.
Time Frame
1 month
Title
Change from baseline in anhedonia (Mood and Symptom Anxiety Questionnaire; Environmental Reward Observation Scale)
Description
Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in anhedonia.
Time Frame
1 month
Title
Change from baseline in anxiety (State Trait Anxiety Inventory).
Description
Change from pre- to post-assessment following AAT plus brief behavioral activation treatment (Aim 3) in anxiety.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-55 Principal psychiatric diagnosis of major depressive disorder Patient Health Questionnaire - 9 item score ≥ 10 Ability to read and speak English sufficiently to complete study procedures Exclusion Criteria: History of psychosis, mania, or substance dependence Current severe medical disorder that requires inpatient treatment or frequent medical follow ups including but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, sever coronary artery disease, sever peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness > 30 minutes Current use of the following medications: antidepressants, benxodiazepines, antipsychotics, mood stabilizers, or other drugs that can acutely affect the hemodynamic response (methylphenidate and acetazolamide) Caffeine intake > 10 cups/day or recent significant changes in consumption MRI exclusions, including claustrophobia, 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 metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue or face rings. Concurrent psychosocial treatment: Participants completing ongoing psychosocial treatment will be required to meet a 12-week stability criteria so that symptom changes as a result of other psychosocial treatments are not confounded with changes due to the research. Inability to complete the initial assessment battery or behavioral training sessions. Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation). These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles T Taylor, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego; Psychiatry Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92037-0855
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34643736
Citation
Bomyea J, Choi SH, Sweet A, Stein M, Paulus M, Taylor C. Neural Changes in Reward Processing Following Approach Avoidance Training for Depression. Soc Cogn Affect Neurosci. 2021 Oct 13;17(3):336-49. doi: 10.1093/scan/nsab107. Online ahead of print.
Results Reference
derived

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The Neurobiology of Approach Avoidance Training in Depression

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