Anxiety Disorders and SymptomsNCT03196544
Novel Behavioral Intervention to Enhance Social Connections in Anxiety and Depression
A study testing Social Approach Training (5 sessions) and Social Approach Training (10 sessions) in people with Anxiety Disorders and Symptoms and Depression, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anxiety Disorders and Symptoms, Depression
- What is being tested?
- Social Approach Training (5 sessions) and Social Approach Training (10 sessions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
About this study
Official title: Novel Behavioral Intervention to Target Social Reward Sensitivity and Attachment
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
- Being tested
- Social Approach Training (5 sessions), Social Approach Training (10 sessions)
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Approach Training (5 sessions)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Approach Training (5 sessions) | Experimental | Not described Receives: Behavioral: Social Approach Training (5 sessions) |
| Social Approach Training (10 sessions) | Experimental | Not described Receives: Behavioral: Social Approach Training (10 sessions) |
| Delayed Treatment (Waitlist) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 10 weeks
Secondary outcomes (1)
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
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start3 Apr 2018
- Primary completion8 Oct 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Taylor, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196544
- Sponsor's protocol ID
- 140102
- Status last verified
- Aug 2020
- First submitted
- 20 Jun 2017
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28060463Kryza-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.
PubMed 38714105
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Behavioral Intervention to Target Social Reward Sensitivity and Attachment
- ClinicalTrials.gov ID
- NCT03196544
- Acronym / sponsor ID
- 140102
- Conditions
- Anxiety Disorders and Symptoms, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Social Approach Training (5 sessions) |
| 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. | Behavioural | Social Approach Training (10 sessions) |
Primary outcome
Change from baseline in neural activation during social reward processing
Time frame: Baseline, 10 weeks
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
1 secondary outcome
Change from baseline in response to a social interaction task
Time frame: Baseline, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Background: PubMed 28060463Taylor 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.
- Derived from this study: PubMed 38714105Kryza-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.
- Individual participant dataSharing planned: Yes
Related trials for Anxiety Disorders and Symptoms
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Approach Training (5 sessions) and Social Approach Training (10 sessions) in people with Anxiety Disorders and Symptoms and Depression, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neural activation during social reward processing (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.