Back to resultsNovel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression
Primary Purpose
Anxiety Disorders and Symptoms, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Approach Training (5 sessions)
Social Approach Training (10 sessions)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders and Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Altman Clinical and Translational Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Social Approach Training (5 sessions)
Social Approach Training (10 sessions)
Delayed Treatment (Waitlist)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline in response to a social interaction task
Change from pre- to post-assessment in physiology, behavior, motivation, and affect in response to a social interaction task
Full Information
NCT ID
NCT03196544
First Posted
June 20, 2017
Last Updated
August 26, 2020
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT03196544
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Approach Training (5 sessions)
Arm Type
Experimental
Arm Title
Social Approach Training (10 sessions)
Arm Type
Experimental
Arm Title
Delayed Treatment (Waitlist)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Social Approach Training (5 sessions)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Approach Training (10 sessions)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in neural activation during social reward processing
Description
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
Time Frame
Baseline, 10 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in response to a social interaction task
Description
Change from pre- to post-assessment in physiology, behavior, motivation, and affect in response to a social interaction task
Time Frame
Baseline, 10 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in social functioning as measured by the NIH Toolbox Companionship Friendship survey
Description
NIH Toolbox Companionship Friendship survey measures social functioning. Items are answered on a 5 point scale, 1 (Never) to 5 (Always). The NIH Toolbox Companionship Friendship survey ranges from 8-40 and higher scores indicate greater perceived availability of friends or companions with whom to interact or affiliate.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in social functioning as measured by the NIH Toolbox Loneliness Surveys
Description
The NIH Toolbox Loneliness survey measures social functioning. Items are answered on a 5 point scale, 1 (Never) to 5 (Always). The NIH Toolbox Loneliness survey ranges from 5-25 and higher scores indicate greater social isolation and feelings of loneliness.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in social functioning as measured by the Social Network Survey
Description
The Social Network Survey measures social functioning by looking at the size and density of a participants social network. Higher scores indicate greater levels of social functioning.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in social connectedness as measured by the Social Connectedness Scale Revised (SCSR)
Description
The SCSR measures social connectedness. Items are answered on a 6 point scale, 1 (Strongly disagree) to 6 (Strongly agree). The SCSR ranges from 20-120 and higher scores indicate greater levels of social connectedness.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in positive affect as measured by PROMIS Positive Affect - Short Form 15a survey
Description
The PROMIS Positive Affect - Short Form 15a survey measures positive affect. Items are answered in a 5 point scale, 1 (Not at all) to 5 (Very much). The PROMIS Positive Affect - Short Form 15a survey ranges from 15-75 and higher scores indicate higher levels of positive affect.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
Description
The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in positive affect as measured by Modified Differential Emotions Scale
Description
The Modified Differential Emotions Scale (mDES) measures positive emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Higher scores on the positive emotions sub-scale indicate higher levels of positive emotion.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in psychological well-being as measured by PROMIS General Life Satisfaction - Short Form 5a survey
Description
The PROMIS General Life Satisfaction - Short Form 5a survey measures psychological well-being. The PROMIS General Life Satisfaction items are answered on a 7 point scale, 1 (Strongly disagree) to 7 (Strongly agree). The PROMIS General Life Satisfaction survey ranges from 5-25 and higher scores indicate higher levels of life satisfaction.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in psychological well-being as measured by PROMIS Meaning and Purpose - Short Form 6a survey
Description
The PROMIS Meaning and Purpose - Short Form 6a survey measure psychological well-being. The PROMIS Meaning and Purpose items are answered on a 5 point scale, 1 (Not at all) to 5 (Very much). The PROMIS Meaning and Purpose survey ranges from 6-30 and higher scores indicate higher levels of self reported meaning and purpose in ones life.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in negative affect as measured by the Positive and Negative Affect Schedule
Description
The Positive and Negative Affect Schedule (PANAS) measures negative affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The negative affect scale ranges from 10-50 and lower scores indicate lower levels of negative affect.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in negative affect as measured by the Modified Differential Emotions Scale
Description
The Modified Differential Emotions Scale (mDES) measures negative emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Lower scores on the negative emotions sub-scale indicate lower levels of negative emotion.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in anxiety as measured by PROMIS Anxiety 7a survey
Description
The PROMIS Anxiety 7a survey measures symptoms of anxiety. Items are rated on a 5 point scale, 1 (Never) to 5 (Always). The scale ranges from 7-35 and higher scores indicate higher levels of anxiety.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
Description
The Overall Anxiety Severity and Impairment Scale (OASIS) measures frequency, severity, and functional impairment of anxiety symptoms. Items are rated on a 4 point scale, 0 (None) to 4 (Extreme). The scale ranges from 0-20 and higher scores indicate higher levels of anxiety.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in depression as measured by PROMIS Depression 8b survey
Description
The PROMIS Depression 8b survey measures symptoms of depression. Items are rated on a 5 point scale, 1 (Never) to 5 (Always). The scale ranges from 8-45 and higher scores indicate higher levels of depression.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in depression as measured by the Patient Health Questionnaire-9
Description
The Patient Health Questionnaire-9 (PHQ-9) measures depression symptoms. Items are rated on a 4 point scale, 0 (Not at all) to 3 (Nearly every day). The scale ranges from 0-27 and higher scores indicate higher levels of depression.
Time Frame
Baseline, 10 weeks
Title
Change from baseline in functional impairment as measured by the Sheehan Disability Scale
Description
The Sheehan Disability Scale measures functional impairment. Items are rated on a 11 point scale, 0 (Not at all) to 10 (Extremely). The scale ranges from 0-30 and higher scores indicate higher levels of functional impairment.
Time Frame
Baseline, 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28060463
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.
Results Reference
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Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression
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