Amplification of Positivity to Enhance Social Connections in Anxiety and Depression

NCT04945239 | Completed DMC

• 1 other identifier: R33MH113769
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety Disorders and Symptoms

Outcome Measures

Primary Outcomes (2)

• Change from baseline in neural activation during social reward processing

  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.

  Baseline, 10 weeks

• Change from baseline in social functioning as measured by the NIH Toolbox Companionship (Friendship and Loneliness) Surveys

  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 or companions with whom to interact or affiliate. The NIH Toolbox Loneliness survey ranges from 5-25 and higher scores indicate greater social isolation and feelings of loneliness. The composite score will be the average of the standardized scores on the Friendship and Loneliness surveys. The composite index is the primary clinical outcome.

  Baseline, 10 weeks

Secondary Outcomes (5)

• Change from baseline in positive affect in response to a social interaction task

  Baseline, 10 weeks

• Change from baseline in positive facial expressions in response to a social interaction task

  Baseline, 10 weeks

• Change from baseline in social approach behavior in response to a social interaction task

  Baseline, 10 weeks

• Change from baseline in future approach motivation in response to a social interaction task

  Baseline, 10 weeks

• Change from baseline in respiratory sinus arrhythmia (RSA) in response to a social interaction task

  Baseline, 10 weeks

Other Outcomes (42)

• Change from baseline in social functioning as measured by the NIH Toolbox Friendship Survey

  Baseline, 10 weeks

• Change from baseline in social functioning as measured by the NIH Toolbox Loneliness Survey

  Baseline, 10 weeks

• Change from baseline in social functioning as measured by the Social Network Survey

  Baseline, 10 weeks

Study Arms (2)

Amplification of Positivity Training (6 Sessions)

EXPERIMENTAL

Behavioral: Amplification of Positivity Training (6 Sessions)

Stress Management Training (6 Sessions)

ACTIVE COMPARATOR

Behavioral: Stress Management Training (6 Sessions)

Interventions

Amplification of Positivity Training (6 Sessions) BEHAVIORAL

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.

Amplification of Positivity Training (6 Sessions)

Stress Management Training (6 Sessions) BEHAVIORAL

6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for activity exercises designed to decrease stress.

Stress Management Training (6 Sessions)

Eligibility Criteria

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

You may qualify if:

• 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.
• Social Connectedness Scale Revised (SCSR) \< 90
• Sheehan Disability Scale (SDS) - Social Domain ≥ 5
• Between the ages of 18-55, inclusive.
• 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.
• Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.

You may not qualify if:

• No telephone or easy access to telephone.
• 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.
• Bipolar I or Psychotic disorders.
• 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.
• 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.
• 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.
• Non-correctable vision or hearing problems, as some tests require intact sensory functioning.
• 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.
• Inability to complete the initial assessment battery or treatment 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

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 30, 2021
• Study Start: March 29, 2021
• Primary Completion: December 10, 2023
• Study Completion: March 25, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)