DepressionNCT04945239
Amplification of Positivity to Enhance Social Connections in Anxiety and Depression
A study testing Amplification of Positivity Training (6 Sessions) and Stress Management Training (6 Sessions) in people with Depression and Anxiety Disorders and Symptoms, 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 -- Amplification of Positivity (AMP) -- 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
- Depression, Anxiety Disorders and Symptoms
- What is being tested?
- Amplification of Positivity Training (6 Sessions) and Stress Management Training (6 Sessions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 25 Mar 2024
- 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 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.
- Social Connectedness Scale Revised (SCSR) < 90
- Sheehan Disability Scale (SDS) - Social Domain ≥ 5
- Between the ages of 18-55, inclusive.
- 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.
- 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 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.
- 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.
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- Non-correctable vision or hearing problems, as some tests require intact sensory functioning.
- 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.
- 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 -- 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.
- Conditions
- Depression, Anxiety Disorders and Symptoms
- Being tested
- Amplification of Positivity Training (6 Sessions), Stress Management Training (6 Sessions)
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplification of Positivity Training (6 Sessions)Behavioural
6 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.
Stress Management Training (6 Sessions)Behavioural
6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for activity exercises designed to decrease stress.
| Study group | Role | What they receive |
|---|---|---|
| Amplification of Positivity Training (6 Sessions) | Experimental | Not described Receives: Behavioral: Amplification of Positivity Training (6 Sessions) |
| Stress Management Training (6 Sessions) | Active comparator | Not described Receives: Behavioral: Stress Management Training (6 Sessions) |
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 in the striatum measured using functional magnetic resonance imaging (fMRI) during reward anticipation trials of the social incentive delay (SID) task. This is the primary target engagement outcome.
Measured: Baseline, 10 weeks
Change from baseline in social functioning as measured by the NIH Toolbox Companionship (Friendship and Loneliness) Surveys
Composite score of the NIH Toolbox Friendship and Loneliness surveys. Items are answered on a 5 point scale, 1 (Never) to 5 (Always). The NIH Toolbox Friendship survey ranges from 8-40 and higher scores indicate greater perceived availability of friends or companions with whom to interact or affiliate. The NIH Toolbox Loneliness survey ranges from 5-25 and higher scores indicate greater social isolation and feelings of loneliness. The composite score will be the average of the standardized scores on the Friendship and Loneliness surveys. The composite index is the primary clinical outcome.
Measured: Baseline, 10 weeks
Secondary outcomes (5)
Change from baseline in positive affect in response to a social interaction task
The state version of the Positive and Negative Affect Schedule (PANAS) will be used to measure current ("right now") positive affect in anticipation of and following the social affiliation task. 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; higher scores indicate greater levels of positive affect.
Measured: Baseline, 10 weeks
Change from baseline in positive facial expressions in response to a social interaction task
Production of positive facial expressions will be coded offline using the Computer Expression Recognition Toolbox (CERT), software that objectively codes action units (AUs) according to the Facial Action Coding System (FACS). AU12 (zygomatic major) reflects positive emotional expressions. Intensity of positive expressions will be measured by the average of AU12 values greater than zero, which identifies when an action unit is more likely to be present than absent.
Measured: Baseline, 10 weeks
Change from baseline in social approach behavior in response to a social interaction task
Observers will rate participant behavior on self-disclosure (the degree of personal information, thoughts, and feelings revealed) and responsiveness (verbal and nonverbal displays reflecting understanding, engagement, and validation). Items are answered on a 7 point scale, 1 (not at all) to 7(very much) with higher scores indicating greater levels of social approach behavior.
Measured: Baseline, 10 weeks
Change from baseline in future approach motivation in response to a social interaction task
The Desire for Future Interaction Scale (DFI) measures the degree to which respondents would be willing to affiliate with their conversation partner again. Items are answered on a 7 point scale, 1 (not at all) to 7 (very much) with higher scores indicating higher levels of future approach motivation.
Measured: Baseline, 10 weeks
Change from baseline in respiratory sinus arrhythmia (RSA) in response to a social interaction task
RSA will be obtained during a resting baseline and throughout the social interaction task using the MP150 data acquisition and analysis systems. RSA is an index of parasympathetic activation and will be computed from the R-wave to R-wave interbeat interval series in the frequency range of spontaneous breathing. Higher levels of RSA indicate higher levels of parasympathetic activation. RSA reactivity will be computed by subtracting RSA during baseline from RSA during the social interaction.
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 posted30 Jun 2021
- Study start29 Mar 2021
- Primary completion10 Dec 2023
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- 134 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
- NCT04945239
- Sponsor's protocol ID
- R33MH113769
- Status last verified
- Jan 2025
- First submitted
- 14 Jun 2021
- Last updated
- 8 Jan 2025
- 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 28060463
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. 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
- NCT04945239
- Acronym / sponsor ID
- R33MH113769
- Conditions
- Depression, Anxiety Disorders and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 30 Jun 2021 (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 -- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amplification of Positivity Training (6 Sessions) | Experimental | Behavioral: Amplification of Positivity Training (6 Sessions) |
| Stress Management Training (6 Sessions) | Active comparator | Behavioral: Stress Management Training (6 Sessions) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- Social Connectedness Scale Revised (SCSR) < 90
- Sheehan Disability Scale (SDS) - Social Domain ≥ 5
- Between the ages of 18-55, inclusive.
- 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.
Key exclusion criteria (10 listed)
- No telephone or easy access to telephone.
- 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.
- 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 |
|---|---|---|
| Amplification of Positivity Training (6 Sessions)6 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 | Amplification of Positivity Training (6 Sessions) |
| Stress Management Training (6 Sessions)6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for activity exercises designed to decrease stress. | Behavioural | Stress Management Training (6 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 in the striatum measured using functional magnetic resonance imaging (fMRI) during reward anticipation trials of the social incentive delay (SID) task. This is the primary target engagement outcome.
Change from baseline in social functioning as measured by the NIH Toolbox Companionship (Friendship and Loneliness) Surveys
Time frame: Baseline, 10 weeks
Composite score of the NIH Toolbox Friendship and Loneliness surveys. Items are answered on a 5 point scale, 1 (Never) to 5 (Always). The NIH Toolbox Friendship survey ranges from 8-40 and higher scores indicate greater perceived availability of friends or companions with whom to interact or affiliate. The NIH Toolbox Loneliness survey ranges from 5-25 and higher scores indicate greater social isolation and feelings of loneliness. The composite score will be the average of the standardized scores on the Friendship and Loneliness surveys. The composite index is the primary clinical outcome.
5 secondary outcomes
Change from baseline in positive affect in response to a social interaction task
Time frame: Baseline, 10 weeks
Change from baseline in positive facial expressions in response to a social interaction task
Time frame: Baseline, 10 weeks
Change from baseline in social approach behavior in response to a social interaction task
Time frame: Baseline, 10 weeks
Change from baseline in future approach motivation in response to a social interaction task
Time frame: Baseline, 10 weeks
Change from baseline in respiratory sinus arrhythmia (RSA) 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 8 Jan 2025.
- 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.
- Individual participant dataSharing planned: Yes
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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 Amplification of Positivity Training (6 Sessions) and Stress Management Training (6 Sessions) in people with Depression and Anxiety Disorders and Symptoms, 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 6 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 8 Jan 2025. 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). The study lists 2 primary outcomes in all. 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 NCT04945239, which also lists 1 linked publication.
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 8 Jan 2025.