N/A
N=29
Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes
Anxiety Disorders and Symptoms · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02330627 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) — -0.41; -0.40; 0.73; -0.02 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Valence System Treatment (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) |
-0.41; -0.40; 0.73; -0.02 | — |
| PRIMARY 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 |
— | — |
| SECONDARY Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) |
0.17; 0.70; -0.19; 0.29 | — |
| SECONDARY 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 |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02330627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.