La Jolla,
California
92037
Purpose:
The overall goal of this project is to develop a novel transdiagnostic behavioral treatment
-- Amplification of Positivity (AMP) -- intended to enhance positive social connections in
individuals with elevated anxiety and/or depression. Social relationship impairments are
common and debilitating consequences of anxiety and depression. Existing treatments have some
beneficial impact on social functioning; however, many people continue to have few and/or
poor quality relationships following treatment, even after experiencing symptom relief. This
study will evaluate the effects of AMP on the brain systems that have been shown to be
important for establishing positive connections with others. Approximately 100 individuals
(ages 18-55) seeking treatment for anxiety or depression will participate in this study.
Participants will be randomly assigned with equal probability to either AMP or stress
management training (SMT) (6 sessions each). Participants will be assessed at baseline and
post-treatment and compared on measures assessing brain responses to social reward (primary
outcome), as well as physiological, behavioral, and emotional responses to social reward
(secondary outcomes). It is hypothesized that the AMP group will experience greater increases
from pre- to post-treatment in activity in brain systems that regulate the processing of
social reward cues (e.g., striatum) relative to participants in the SMT group. It is also
hypothesized that changes in brain activation to social reward from pre- to post-treatment
will be correlated with the degree of improvement in social connectedness.
Criteria:
Inclusion Criteria:
1. Score on the Patient Health Questionnaire (PHQ)-9 is 10 or higher and/or score on the
Overall Anxiety Severity and Impairment Scale (OASIS) is 8 or higher.
2. Social Connectedness Scale Revised (SCSR) < 90
3. Sheehan Disability Scale (SDS) - Social Domain ≥ 5
4. Between the ages of 18-55, inclusive.
5. Have signed informed consent document(s) indicating that the participant understands
the purpose of and procedures required for the study and is willing to participate in
the study.
6. Have sufficient proficiency in English language to understand and complete interviews,
questionnaires, and all other study procedures.
Exclusion Criteria:
1. No telephone or easy access to telephone.
2. Any substance use disorder in the past 6 months except subjects with mild alcohol,
nicotine, caffeine, and marijuana use disorders will be permitted in the study, and
given referrals for substance use treatment which may occur concurrently.
3. Bipolar I or Psychotic disorders.
4. Moderate to severe traumatic brain injury with evidence of neurological deficits,
neurological disorders, or severe or unstable medical conditions that might be
compromised by participation in the study.
5. Current and regular use (more days than not during the past 30 days) of a medication
that could affect brain functioning, such as anxiolytics, antipsychotics,
antidepressants, mood stabilizers, beta-blockers, sleep medications, opioids/codeine,
migraine medications.
6. 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 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
minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body
piercings, and pregnancy.
7. Non-correctable vision or hearing problems, as some tests require intact sensory
functioning.
8. Concurrent psychosocial treatment: Participants completing ongoing empirically
supported treatments, e.g., Cognitive behavioral therapy (CBT) targeting the
presenting problem will be required to meet 12-week stability criteria so that symptom
changes as a result of other psychosocial treatments are not confounded with changes
due to the research.
9. Inability to complete the initial assessment battery or treatment sessions.
10. 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.