Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression

NCT03196544 | Completed DMC

• 1 other identifier: 140102
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to develop a novel transdiagnostic behavioral treatment -- social approach training -- intended to enhance positive social connections in individuals with elevated anxiety and/or depression. Social relationship impairments are pervasive 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 social approach training on the brain systems that have been shown to be important for establishing positive connections with others. Approximately 60 individuals (ages 18-55) seeking treatment for anxiety or depression will participate in this study. Participants will be randomly assigned with equal probability to one of two versions of social approach training (5 or 10 sessions) or a waitlist (assessment only) control group. 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 participants assigned to social approach training will display greater increases from pre- to post-treatment in activity in brain systems that regulate the processing of social reward (e.g., striatum) relative to participants in the control group. This study will also determine whether the 5- vs. 10-session versions of the treatment program result in meaningful differences, compared to each other, in how the brain responds to social reward.

Conditions

Anxiety Disorders and Symptoms; Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline in neural activation during social reward processing

  Change from pre- to post-assessment in neural activation measured using functional magnetic resonance imaging (fMRI) during reward trials of the social incentive delay (SID) task

  Baseline, 10 weeks

Secondary Outcomes (1)

• Change from baseline in response to a social interaction task

  Baseline, 10 weeks

Other Outcomes (16)

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

  Baseline, 10 weeks

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

  Baseline, 10 weeks

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

  Baseline, 10 weeks

Study Arms (3)

Social Approach Training (5 sessions)

EXPERIMENTAL

Behavioral: Social Approach Training (5 sessions)

Social Approach Training (10 sessions)

EXPERIMENTAL

Behavioral: Social Approach Training (10 sessions)

Delayed Treatment (Waitlist)

NO INTERVENTION

Interventions

Social Approach Training (5 sessions) BEHAVIORAL

5 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.

Social Approach Training (5 sessions)

Social Approach Training (10 sessions) BEHAVIORAL

10 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.

Social Approach Training (10 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 PHQ-9 is 10 or higher and/or score on the 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 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 year except subjects with mild alcohol, nicotine, caffeine, and marijuana use disorders will be permitted in the study.
• 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 psychosocial treatment for 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 (2)

• 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

• Kryza-Lacombe M, Spaulding I, Ku CK, Pearson N, Stein MB, Taylor CT. Amplification of positivity for depression and anxiety: Neural prediction of treatment response. Behav Res Ther. 2024 Jul;178:104545. doi: 10.1016/j.brat.2024.104545. Epub 2024 Apr 23.

  PMID: 38714105 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

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: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: April 3, 2018
• Primary Completion: October 8, 2019
• Study Completion: April 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)