Anxiety Disorders and SymptomsNCT02330627
Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes
A study testing Positive Valence System Treatment 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 proposed project aims to test the efficacy and neural correlates of a behavioral treatment program comprised of positive activity interventions in a sample of individuals seeking treatment for anxiety 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?
- Positive Valence System Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Between the ages of 18-55, inclusive.
- Have sufficient proficiency in the 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.
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- non-correctable vision or hearing problems, as some tests require intact sensory functioning.
- Concurrent psychosocial treatment: Participants completing ongoing psychosocial treatment will be required to meet a 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
UCSD Psychiatry Clinical Research
La Jolla, California, 92037-0855
About this study
The proposed project aims to test the efficacy and neural correlates of a behavioral treatment program comprised of positive activity interventions in a sample of individuals seeking treatment for anxiety or depression. Participants will be randomly assigned to an immediate or delayed treatment condition, and will be compared on measures of positive and negative emotions, brain responses to reward and punishment/loss, subjective well-being, and symptoms at baseline and post-treatment.
Read the detailed description
Current treatment approaches for anxiety and depression emphasize the reduction of negative emotions and distress as the central goal of treatment. However, these conditions are also characterized by low levels of positive emotions, which, although fundamental for life satisfaction and well-being, have traditionally not been a focus of treatment. The proposed project aims to test the efficacy of an integrated treatment regimen designed to modulate functioning of core component processes of the positive emotion system. Specifically, we will implement positive emotion enhancement procedures, previously tested and validated in non-clinical samples (Huffman et al., 2011; Lyubomirsky et al., 2005), in a broad community sample of n=30 individuals seeking treatment for anxiety or depression. Participants will be randomly assigned to a multi-session positive valence system targeted treatment (n=15) or a waitlist control group (n=15). Participants will be assessed at baseline and post-treatment and compared on measures of positive and negative emotions, brain responses to reward and punishment/loss, subjective well-being, and symptoms. Aim 1 will test the hypothesis that participants assigned to the positive emotion enhancement intervention will display greater increases in positive affect and enhanced activity in neural systems that regulate responses to reward (e.g., nucleus accumbens) relative to participants in the waitlist control group. Aim 2 will explore whether the effects of the positive emotion system treatment generalize to parallel measures of the negative emotion system (i.e., negative affect and neural reactivity to aversive outcomes). We will also explore the effects of the intervention on subjective well-being and life satisfaction, and will examine the relationship between changes in subjective emotions and neural indices of positive and negative valence functioning with changes in well-being and life satisfaction.
- Conditions
- Anxiety Disorders and Symptoms, Depression
- Being tested
- Positive Valence System Treatment
- 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.
Positive Valence System TreatmentBehavioural
Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Positive Valence System Treatment | Experimental | 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Receives: Behavioral: Positive Valence System Treatment |
| 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 Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
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.
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.
Participants' scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of positive affect at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in positive affect from baseline to post-treatment.
Measured: Baseline, 10 weeks
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Medial Prefrontal Cortex, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Reward Trials on the Monetary Incentive Delay (MID) Task
Change from pre- to post-assessment in neural activation during reward trials on the MID task.
Measured: Baseline, 10 weeks
Secondary outcomes (2)
Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
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.
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.
Participants' composite scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of negative affect at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in negative affect from baseline to post-treatment.
Measured: Baseline, 10 weeks
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Insula, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Loss Trials on the Monetary Incentive Delay (MID) Task
Change from pre- to post-assessment in neural activation during loss trials on the MID
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 posted5 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Charles Taylor, University of California, San Diego
- Investigators
- Charles T Taylor, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330627
- Sponsor's protocol ID
- 5UL1TR000100
- Other IDs
- 5UL1TR000100
- Status last verified
- Nov 2021
- First submitted
- 24 Dec 2014
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 38714105Kryza-Lacombe M, Pearson N, Lyubomirsky S, Stein MB, Wiggins JL, Taylor CT. Changes in neural reward processing following Amplification of Positivity treatment for depression and anxiety: Preliminary findings from a randomized waitlist controlled trial. Behav Res Ther. 2021 Jul;142:103860. doi: 10.1016/j.brat.2021.103860. Epub 2021 Apr 15.
PubMed 33894554Taylor CT, Pearlstein SL, Kakaria S, Lyubomirsky S, Stein MB. Enhancing Social Connectedness in Anxiety and Depression Through Amplification of Positivity: Preliminary Treatment Outcomes and Process of Change. Cognit Ther Res. 2020 Aug;44(4):788-800. doi: 10.1007/s10608-020-10102-7. Epub 2020 Apr 19.
PubMed 32661447
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes
- ClinicalTrials.gov ID
- NCT02330627
- Acronym / sponsor ID
- 5UL1TR000100
- Conditions
- Anxiety Disorders and Symptoms, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Posted 3 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project aims to test the efficacy and neural correlates of a behavioral treatment program comprised of positive activity interventions in a sample of individuals seeking treatment for anxiety or depression. Participants will be randomly assigned to an immediate or delayed treatment condition, and will be compared on measures of positive and negative emotions, brain responses to reward and punishment/loss, subjective well-being, and symptoms at baseline and post-treatment.
Detailed description
Current treatment approaches for anxiety and depression emphasize the reduction of negative emotions and distress as the central goal of treatment. However, these conditions are also characterized by low levels of positive emotions, which, although fundamental for life satisfaction and well-being, have traditionally not been a focus of treatment. The proposed project aims to test the efficacy of an integrated treatment regimen designed to modulate functioning of core component processes of the positive emotion system. Specifically, we will implement positive emotion enhancement procedures, previously tested and validated in non-clinical samples (Huffman et al., 2011; Lyubomirsky et al., 2005), in a broad community sample of n=30 individuals seeking treatment for anxiety or depression. Participants will be randomly assigned to a multi-session positive valence system targeted treatment (n=15) or a waitlist control group (n=15). Participants will be assessed at baseline and post-treatment and compared on measures of positive and negative emotions, brain responses to reward and punishment/loss, subjective well-being, and symptoms. Aim 1 will test the hypothesis that participants assigned to the positive emotion enhancement intervention will display greater increases in positive affect and enhanced activity in neural systems that regulate responses to reward (e.g., nucleus accumbens) relative to participants in the waitlist control group. Aim 2 will explore whether the effects of the positive emotion system treatment generalize to parallel measures of the negative emotion system (i.e., negative affect and neural reactivity to aversive outcomes). We will also explore the effects of the intervention on subjective well-being and life satisfaction, and will examine the relationship between changes in subjective emotions and neural indices of positive and negative valence functioning with changes in well-being and life satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Valence System Treatment | Experimental | Behavioral: Positive Valence System Treatment10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. |
| 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 (3 listed)
- Score on the PHQ-9 is 10 or higher and/or score on the OASIS is 8 or higher.
- Between the ages of 18-55, inclusive.
- Have sufficient proficiency in the 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 |
|---|---|---|
| Positive Valence System TreatmentClinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions. | Behavioural | Positive Valence System Treatment |
Primary outcome
Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
Time frame: Baseline, 10 weeks
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. 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. Participants' scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of positive affect at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in positive affect from baseline to post-treatment.
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Medial Prefrontal Cortex, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Reward Trials on the Monetary Incentive Delay (MID) Task
Time frame: Baseline, 10 weeks
Change from pre- to post-assessment in neural activation during reward trials on the MID task.
2 secondary outcomes
Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
Time frame: Baseline, 10 weeks
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Insula, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Loss Trials on the Monetary Incentive Delay (MID) Task
Time frame: Baseline, 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Derived from this study: PubMed 33894554Kryza-Lacombe M, Pearson N, Lyubomirsky S, Stein MB, Wiggins JL, Taylor CT. Changes in neural reward processing following Amplification of Positivity treatment for depression and anxiety: Preliminary findings from a randomized waitlist controlled trial. Behav Res Ther. 2021 Jul;142:103860. doi: 10.1016/j.brat.2021.103860. Epub 2021 Apr 15.
- Derived from this study: PubMed 32661447Taylor CT, Pearlstein SL, Kakaria S, Lyubomirsky S, Stein MB. Enhancing Social Connectedness in Anxiety and Depression Through Amplification of Positivity: Preliminary Treatment Outcomes and Process of Change. Cognit Ther Res. 2020 Aug;44(4):788-800. doi: 10.1007/s10608-020-10102-7. Epub 2020 Apr 19.
- Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention.Link provided by the sponsor.
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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.
Charles T Taylor, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Valence System Treatment 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 3 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 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) (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 NCT02330627, which also lists 4 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 8 Nov 2021.