Clinical trial NCT04945239: Amplification of Positivity 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: Depression
Anxiety Disorders and Symptoms
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 134
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 -- 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in neural activation during social reward processing
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social functioning as measured by the NIH Toolbox Companionship (Friendship and Loneliness) Surveys
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change from baseline in positive affect in response to a social interaction task
timeFrame: Baseline, 10 weeks
measure: Change from baseline in positive facial expressions in response to a social interaction task
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social approach behavior in response to a social interaction task
timeFrame: Baseline, 10 weeks
measure: Change from baseline in future approach motivation in response to a social interaction task
timeFrame: Baseline, 10 weeks
measure: Change from baseline in respiratory sinus arrhythmia (RSA) 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 Friendship Survey
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social functioning as measured by the NIH Toolbox Loneliness Survey
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 functional impairment as measured by the Sheehan Disability Scale
timeFrame: Baseline, 10 weeks
measure: Change from baseline in positive affect as measured by Patient-Reported Outcomes Measurement Information System (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 anxiety as measured by PROMIS Anxiety 7a survey
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 perceived emotional support as measured by the NIH Toolbox Emotional Support
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social activity satisfaction as measured by the PROMIS Satisfaction with Participation in Discretionary Social Activities - Short Form 7a
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social activity satisfaction as measured by the PROMIS Satisfaction with Social Roles and Activities
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social anxiety symptoms as measured by the Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in social anhedonia as measured by the Specific Loss of Interest and Pleasure Scale (SLIPS)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in anxiety-related general distress as measured by Mood and Anxiety Symptom Questionnaire - Short Form (MASQ-SF)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in depression-related general distress as measured by Mood and Anxiety Symptom Questionnaire - Short Form (MASQ-SF)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in anxious arousal as measured by Mood and Anxiety Symptom Questionnaire - Short Form (MASQ-SF)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in anhedonic depressive symptoms as measured by Mood and Anxiety Symptom Questionnaire - Short Form (MASQ-SF)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in emotion regulation strategies as measured by Emotion Regulation Questionnaire
timeFrame: Baseline, 10 weeks
measure: Change from baseline in regulation of positive emotional experiences as measured by Responses to Positive Affect Questionnaire (RPA)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in capacity to cope with adversity as measured by Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in trait anxious and avoidant attachment as measured by the Experiences in Close Relationships-Revised (ECR-R)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in self-efficacy beliefs in the domain of emotion regulation as measured by the Regulatory Emotional Self-Efficacy Scale (RESE)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in perceived self-efficacy as measured by the PROMIS Self-Efficacy (General; 4 item)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in trait mindfulness as measured by the Five-Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) - 15 item
timeFrame: Baseline, 10 weeks
measure: Change from baseline in interpersonal difficulties based on a circumplex model of personality as measured by the Inventory of Interpersonal Problems-32 (IIP-32)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in low arousal positive affect experienced during the past week as measured by the Relaxed and Safe/Content Scales on the Types of Positive Affect Scale (TPAS)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in mood during a social interaction task as measured by Subjective Mood Ratings
timeFrame: Baseline, 10 weeks
measure: Change from baseline in behavior during a social interaction task as measured by the Social Judgment Questionnaire (SJQ)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in perceived connectedness to an interaction partner during a social interaction task as measured by the Inclusion of Other in the Self (IOS)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in safety behaviors during a social interaction task as measured by the Safety Behaviors Questionnaire (SBQ)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in suicidal ideation as measured by the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: Baseline, 10 weeks
measure: Change from baseline in state positive affect, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 10 weeks
measure: Change from baseline in state negative affect, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 10 weeks
measure: Change from baseline in perceived quality of social interactions, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 10 weeks
measure: Change from baseline in perceived social connectedness/loneliness, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 10 weeks
measure: Proportion of times engaged in social interaction, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 10 weeks
measure: Number of social interactions per day, measured via Ecological Momentary Assessment
timeFrame: Baseline 5-day period to Post-Intervention 5-day period, 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.