The Neurobiology of Approach Avoidance Training in Depression

NCT02330744 | Completed

• 1 other identifier: 21695
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-training (5 minutes)

Secondary Outcomes (2)

• Response bias to rewards on the Probabilistic Reward Task (PRT)

  Post-training (20 minutes) and 1 month

• Response to social interaction task

  Post-training (30 minutes) and 1 month

Other Outcomes (5)

• Change from baseline in depression (Patient Health Questionnaire-9; Beck Depression Inventory II, composite)

  1 month

• Change from baseline in positive affect (Positive and Negative Affect Schedule)

  1 month

• Change from baseline in social relationship functioning (Social Connectedness Scale - Revised; Interpersonal Outcomes Scale)

  1 month

Study Arms (2)

Approach-positive AAT

EXPERIMENTAL

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

Behavioral: Approach-positive AAT

Control AAT

PLACEBO COMPARATOR

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

Behavioral: Control AAT

Interventions

Approach-positive AAT BEHAVIORAL

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).

Approach-positive AAT

Control AAT BEHAVIORAL

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).

Control AAT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

University of California, San Diego; Psychiatry Clinical Research

San Diego, California, 92037-0855, United States

Location

Related Publications (1)

• 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.

  PMID: 34643736 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Charles T Taylor, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 5, 2015
• Study Start: July 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

US (1)