La Jolla, California 92037

  • Anxiety Disorders and Symptoms

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.


Study is Available At:


Original ID:

R33MH113769


NCT ID:

NCT04945239


Secondary ID:


Study Acronym:


Brief Title:

Amplification of Positivity to Enhance Social Connections in Anxiety and Depression


Official Title:

Novel Behavioral Intervention to Target Social Reward Sensitivity and Attachment


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Charles T Taylor, PhD
858.534.9446
c1taylor@health.ucsd.edu
Backup Contact:Taylor Smith, BS
858.534.6407
trs004@health.ucsd.edu

Study Dates

Start Date:March 29, 2021
Completion Date:July 31, 2023
Completion Type:Anticipated
Primary Completion Date:April 30, 2023
Primary Completion Type:Anticipated
Verification Date:October 2021
Last Changed Date:October 6, 2021
First Received Date:June 14, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from baseline in neural activation during social reward processing
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:Change from pre- to post-assessment in neural activation in the striatum measured using functional magnetic resonance imaging (fMRI) during reward anticipation trials of the social incentive delay (SID) task. This is the primary target engagement outcome.
Outcome Type:Primary Outcome
Measure:Change from baseline in social functioning as measured by the NIH Toolbox Companionship (Friendship and Loneliness) Surveys
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:Composite score of the NIH Toolbox Friendship and Loneliness surveys. Items are answered on a 5 point scale, 1 (Never) to 5 (Always). The NIH Toolbox Friendship survey ranges from 8-40 and higher scores indicate greater perceived availability of friends o
Outcome Type:Secondary Outcome
Measure:Change from baseline in positive affect in response to a social interaction task
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:The state version of the Positive and Negative Affect Schedule (PANAS) will be used to measure current ("right now") positive affect in anticipation of and following the social affiliation task. Items are answered on a 5 point scale, 1 (Very slightly or n
Outcome Type:Secondary Outcome
Measure:Change from baseline in positive facial expressions in response to a social interaction task
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:Production of positive facial expressions will be coded offline using the Computer Expression Recognition Toolbox (CERT), software that objectively codes action units (AUs) according to the Facial Action Coding System (FACS). AU12 (zygomatic major) reflec
Outcome Type:Secondary Outcome
Measure:Change from baseline in social approach behavior in response to a social interaction task
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:Observers will rate participant behavior on self-disclosure (the degree of personal information, thoughts, and feelings revealed) and responsiveness (verbal and nonverbal displays reflecting understanding, engagement, and validation). Items are answered o
Outcome Type:Secondary Outcome
Measure:Change from baseline in future approach motivation in response to a social interaction task
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:The Desire for Future Interaction Scale (DFI) measures the degree to which respondents would be willing to affiliate with their conversation partner again. Items are answered on a 7 point scale, 1 (not at all) to 7 (very much) with higher scores indicatin
Outcome Type:Secondary Outcome
Measure:Change from baseline in respiratory sinus arrhythmia (RSA) in response to a social interaction task
Time Frame:Baseline, 10 weeks
Safety Issues:False
Description:RSA will be obtained during a resting baseline and throughout the social interaction task using the MP150 data acquisition and analysis systems. RSA is an index of parasympathetic activation and will be computed from the R-wave to R-wave interbeat interva

Study Interventions

Intervention Type:Behavioral
Name:Amplification of Positivity Training (6 Sessions)
Description:6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
Arm Name:Amplification of Positivity Training (6 Sessions)
Intervention Type:Behavioral
Name:Stress Management Training (6 Sessions)
Description:6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for activity exercises designed to decrease stress.
Arm Name:Stress Management Training (6 Sessions)

Study Arms

Study Arm Type:Experimental
Arm Name:Amplification of Positivity Training (6 Sessions)
Study Arm Type:Active Comparator
Arm Name:Stress Management Training (6 Sessions)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Taylor CT, Lyubomirsky S, Stein MB. Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention. Depress Anxiety. 2017 Mar;34(3):267-280. doi: 10.1002/da.22593. Epub 2017 Jan 6.
PMID:28060463

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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