Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Disorders and Symptoms Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Social Approach Training (5 sessions)

Group Type EXPERIMENTAL

Social Approach Training (5 sessions)

Intervention Type 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 (10 sessions)

Group Type EXPERIMENTAL

Social Approach Training (10 sessions)

Intervention Type 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.

Delayed Treatment (Waitlist)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Social Approach Training (5 sessions)

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

Social Approach Training (10 sessions)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No