Clinical trial NCT02330627: Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes
Official title: Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2015-01-05
Enrollment: 29
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 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.

Eligibility criteria: Inclusion Criteria:

1. Score on the PHQ-9 is 10 or higher and/or score on the OASIS is 8 or higher.
2. Between the ages of 18-55, inclusive.
3. Have sufficient proficiency in the 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 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.
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 Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
timeFrame: Baseline, 10 weeks
measure: 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
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)
timeFrame: Baseline, 10 weeks
measure: 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
timeFrame: Baseline, 10 weeks
Other outcomes:
measure: Change From Baseline in Quality of Life and Well-being (Composite of Quality of Life, Enjoyment, and Satisfaction Questionnaire; Satisfaction With Life Scale)
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in Anxiety (Overall Anxiety Severity and Impairment Scale; State Trait Anxiety Inventory - Trait Composite)
timeFrame: Baseline, 10 weeks
measure: Change From Baseline in Depression (Patient Health Questionnaire-9; Beck Depression Inventory-II Composite)
timeFrame: Baseline, 10 weeks
Locations:
city: La Jolla
country: United States
facility: UCSD Psychiatry Clinical Research
state: California
Study officials:
affiliation: University of California, San Diego
name: Charles T Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
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.
citation: Kryza-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.
citation: Taylor 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.