Clinical trial NCT03196544: Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression
Official title: Novel Behavioral Intervention to Target Social Reward Sensitivity and Attachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Score on the PHQ-9 is 10 or higher and/or score on the 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 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 year except subjects with mild alcohol, nicotine, caffeine, and marijuana use disorders will be permitted in the study.
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 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.
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.

Primary outcomes:
measure: Change from baseline in neural activation during social reward processing
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change from baseline in response to a social interaction task
timeFrame: Baseline, 10 weeks
Other outcomes:
measure: Change from baseline in social functioning as measured by the NIH Toolbox Companionship Friendship survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social functioning as measured by the NIH Toolbox Loneliness Surveys
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social functioning as measured by the Social Network Survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social connectedness as measured by the Social Connectedness Scale Revised (SCSR)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in positive affect as measured by PROMIS Positive Affect - Short Form 15a survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
timeFrame: Baseline, 10 weeks
measure: Change from baseline in positive affect as measured by Modified Differential Emotions Scale
timeFrame: Baseline, 10 weeks
measure: Change from baseline in psychological well-being as measured by PROMIS General Life Satisfaction - Short Form 5a survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in psychological well-being as measured by PROMIS Meaning and Purpose - Short Form 6a survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in negative affect as measured by the Positive and Negative Affect Schedule
timeFrame: Baseline, 10 weeks
measure: Change from baseline in negative affect as measured by the Modified Differential Emotions Scale
timeFrame: Baseline, 10 weeks
measure: Change from baseline in anxiety as measured by PROMIS Anxiety 7a survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
timeFrame: Baseline, 10 weeks
measure: Change from baseline in depression as measured by PROMIS Depression 8b survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in depression as measured by the Patient Health Questionnaire-9
timeFrame: Baseline, 10 weeks
measure: Change from baseline in functional impairment as measured by the Sheehan Disability Scale
timeFrame: Baseline, 10 weeks
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
Study officials:
References:
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.