Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes

NCT02330627 | Completed Results

• 1 other identifier: 5UL1TR000100
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders and Symptoms; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 10 weeks

Secondary Outcomes (2)

• Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)

  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

  Baseline, 10 weeks

Other Outcomes (3)

• Change From Baseline in Quality of Life and Well-being (Composite of Quality of Life, Enjoyment, and Satisfaction Questionnaire; Satisfaction With Life Scale)

  Baseline, 10 weeks

• Change From Baseline in Anxiety (Overall Anxiety Severity and Impairment Scale; State Trait Anxiety Inventory - Trait Composite)

  Baseline, 10 weeks

• Change From Baseline in Depression (Patient Health Questionnaire-9; Beck Depression Inventory-II Composite)

  Baseline, 10 weeks

Study Arms (2)

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.

Behavioral: Positive Valence System Treatment

Delayed Treatment (Waitlist)

NO INTERVENTION

Interventions

Positive Valence System Treatment BEHAVIORAL

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.

Positive Valence System Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCSD Psychiatry Clinical Research

La Jolla, California, 92037-0855, United States

Location

Related Publications (4)

• 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.

  PMID: 28060463 RESULT

• Kryza-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.

  PMID: 38714105 DERIVED

• 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.

  PMID: 33894554 DERIVED

• 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.

  PMID: 32661447 DERIVED

Related Links

• Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention.

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Charles Taylor
• Organization: University of California, San Diego

c1taylor@ucsd.edu

8585349446

Study Officials

• Charles T Taylor, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 5, 2015
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 8, 2021
• Results First Posted: April 3, 2020

Record last verified: 2021-11

Locations

US (1)