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Treatment for Affect Dimensions

NCT03439748 — Not applicable, Completed, 85 participants, University of California, Los Angeles

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Reward Sensitivity as a Mechanism of Positive Affect Treatment

RegistryNCT03439748, acronym TAD
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment85 (Actual)
SponsorUniversity of California, Los Angeles (Other); collaborators: Southern Methodist University
ConditionsDepression, Anxiety
InterventionsPositive Affect Treatment, Negative Affect Treatment (Behavioral)
Datesstart 2019-02-01, primary completion 2021-06-30, completion 2021-06-30, first posted 2018-02-20, last updated 2024-06-12
Locations2 sites in United States

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-Summary

The purpose of this study is to evaluate the efficacy and targets of Positive Affect Treatment, a psychotherapy specifically aimed at enhancing reward sensitivity in individuals with low positive affect (a core feature of anhedonia) in the context of depression or anxiety.

Target enrollment is 68 male and female participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years, who will be randomized to either Positive Affect Treatment or Negative Affect Treatment (designed to reduce threat sensitivity). Participants will complete laboratory tests, psychiatric assessments, and self-report questionnaires as part of the study.

The total length of participation is around 4 months.

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+Detailed description

Low positive affect in the context of depression or anxiety has been relatively resistant to pharmacological and psychological treatments. Newer treatments that focus upon positivity or reward sensitivity have shown promising results.

As an NIMH funded R61 phase trial, the purpose of the current randomized controlled trial is to evaluate the efficacy and targets of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Targets include behavioral, cognitive, physiological and experiential measures of three reward processes: reward anticipation, response to reward attainment, and reward learning. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity.

Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, and Week 15 (post). Targets are assessed at baseline, Week 5, Week 10, and Week 15. Statistical models evaluate whether change in outcomes and change in target measures are greater as a result of Positive Affect Treatment compared to Negative Affect Treatment and whether changes in target measures correlate with changes in outcome measures.

Target enrollment is 68 male and female participants with low positive affect and depression or anxiety and impaired functioning between the ages of 18 and 65 who will be randomized to Positive Affect Treatment or Negative Affect Treatment, each comprising 15 individual psychotherapy sessions.

Participants will complete laboratory tests and psychiatric assessments and self-report questionnaires as part of the study. Total length of participation is around 4 months.

+Arms and interventions

ArmTypeInterventionsDescription
Positive Affect TreatmentExperimentalBehavioral: Positive Affect Treatment15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Negative Affect TreatmentActive comparatorBehavioral: Negative Affect Treatment15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
  • Positive Affect Treatment (Behavioral): Sessions 1-7: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects (continued for sessions 8-15) Sessions 8-10: Cognitive exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention.
  • Negative Affect Treatment (Behavioral): Sessions 1-7: Exposure therapy to feared or avoided situations, sensations, or memories (continued for sessions 8-15) Sessions 8-10: Cognitive restructuring of probability, cost, and attributional biases Sessions 11-14: Capnometry-assisted respiratory training Session 15: Relapse prevention

+Outcome measures

Primary outcomes

  • Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) [Week 0, Week 5, Week 10, Week 16]: Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect.
  • Interviewer Anhedonia Ratings [Week 0, Week 5, Week 10, Week 16]: Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia.
  • Depression Anxiety and Stress Scale (DASS-21) [Week 0, Week 5, Week 10, Week 16]: Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency.

Secondary outcomes

  • Sheehan Disability Scale (SDS) [Week 0, Week 5, Week 10, Week 16]: Reported impairment due to symptoms (score range: 0-30) with higher scores indicating greater impairment. Includes reported number of days of missed school/work and number of days of reduced productivity. Statistical analyses have not yet been conducted for this outcome measure.
  • Beck Depression Inventory (BDI) [Week 0, Week 5, Week 10, Week 16]: Reported suicidal ideation (item 9 on the BDI), scores range from 0-3 with higher scores indicating a higher degree of suicidal ideation. Statistical analyses have not yet been conducted for this outcome measure.
  • Daily Activity/Social Interaction (Actigraph) [Week 0, Week 5, Week 10, Week 16]: We intended to collect data on energy expenditure over four 7-day periods (at week 0, week 5, week 10, and week 16) using a wrist-worn Actigraph tri-axial accelerometer. However, the use of Actigraph monitors was terminated early in the study due to the onset of the COVID-19 pandemic.
  • Effort Expenditure for Rewards Task (EEfRT) [Week 0, Week 5, Week 10, Week 16]: The Effort Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial task used to objectively assess decision-making and willingness to expend effort for reward. The dependent variable is the ratio of hard (high-effort) choices to the total number of trials. Results range from 0 to 1, with higher values indicating a higher proportion of hard (high-effort) choices. Results show the mean proportion of high-effort choices.
  • Monetary Incentive Task [Week 0, Week 5, Week 10, Week 16]: Heart rate acceleration during the Monetary Incentive Task (MIT) was used to measure cardiac responding to the prospect of a monetary reward. The dependent variable is the interbeat interval acceleration during the task (score range in our sample: -0.16 to 0.17). Higher values indicate greater cardiac responding to the prospect of monetary reward.
  • Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) [Week 0, Week 5, Week 10, Week 16]: Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
  • Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items [Week 0, Week 5, Week 10, Week 16]: Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort.
  • Dimensional Anhedonia Rating Scale-Consummatory Items [Week 0, Week 5, Week 10, Week 16]: Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure.
  • Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli [Week 0, Week 5, Week 10, Week 16]: The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for disengagement bias from sad faces. This is calculated as follows: (Cue appears proximal to emotional face in the pair of emotional face and random blur image: reaction time for target distal to emotional face minus reaction time for target proximal to emotional face) minus (Cue proximal to neutral face in pair of neutral face and random blur image: reaction time for target distal to neutral face minus reaction time for target proximal to neutral face). The range of values in our sample was: -309.28 to 283.45.
  • Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli [Week 0, Week 5, Week 10, Week 16]: The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for engagement bias from happy faces. This is calculated as follows: (Cue probe distal to negative image in negative/abstract image pair: RT for target probe distal to negative image minus RT for target probe proximal to negative image) minus (Cue probe distal to neutral image in neutral/abstract image pair: RT for target probe distal to neutral image minus RT for target probe proximal to neutral image). The range of data in our sample was: -237.82 to to 343.93. Statistical analyses have not yet been conducted for this outcome measure.
  • International Affective Picture System Task [Week 0, Week 5, Week 10, Week 16]: Heart rate acceleration during presentation of images from the International Affective Picture Systems (IAPS) was used to assess cardiac responding to positive images. The dependent variable is heart rate acceleration during the 6 seconds of positive image presentation relative to the last 2 seconds before picture onset. Higher values indicate greater cardiac responding to positive images. The range of values in our sample was: -0.12 to 0.09.
  • Temporal Experience of Pleasure Scale (Consummatory Subscale) [Week 0, Week 5, Week 10, Week 16]: Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure
  • Probabilistic Reward Task (PRT) [Week 0, Week 5, Week 10, Week 16]: The Probabilistic Reward Task (PRT) is a computer-based multi-trial task used to objectively assess the propensity to modulate behavior as a function of prior reinforcements. The dependent variable is response bias (measured as accuracy) toward the more frequently rewarded stimulus. A high response bias emerges when subjects show high rates of correct identification (hits) for the rich stimulus and high miss rates for the lean stimulus (i.e., the stimulus associated with less frequent rewards). Higher values indicate a greater propensity to modulate behavior as a function of prior reinforcements. The range of values in our sample was: -0.58 to 0.78.
  • Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) [Week 0, Week 5, Week 10, Week 16]: The Pavlovian Instrumental Transfer (PIT) task assesses the extent to which a conditional stimulus paired with reward influences instrumental responding to gain rewards. The dependent variable was handgrip force exerted in response to stimuli during a test phase following Pavlovian conditioning. Higher values indicate greater instrumental responding to gain rewards as a function of Pavlovian conditioning to a conditional stimulus paired with reward. The range of values in our sample was: -18.76 to 61.30.
  • Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) [Week 0, Week 5, Week 10, Week 16]: Within the Pavlovian Instrumental Transfer Task (PIT), participants rate the pleasantness (0-4) for three conditional stimuli to indicate the perceived value of reward associated with each one. The dependent variable is the self-reported pleasantness for rewarded stimuli compared to nonrewarded stimuli. This is calculated by first taking the average of participants' pleasantness ratings for the three CS+s and CS-s, and then subtracting the average CS- ratings from the average CS+ ratings. Higher values indicate greater responding to Pavlovian conditioning during the task.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* English-speaking
* Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression, greater to or equal to 6 for anxiety, or greater to or equal to 10 for stress on the Depression, Anxiety, and Stress Scale; and scores of greater than or equal to 5 on any Sheehan Disability Scale subscale.
* Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.

Exclusion Criteria:

* Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes)
* Active suicidal ideation
* Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
* Substance abuse in the last 6 months or dependence within last 12 months.
* 11 or more cigarettes per week or nicotine equivalent.
* History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine)
* Pregnancy
* Bupropion, dopaminergic or neuroleptic medication use in the past 6 months
* Heterocyclics and SSRIs are permitted if stabilized (3 months) and PRN benzodiazepines and beta-blockers are permitted but discouraged on laboratory assessment visits
* Refusal of video/audio-taping

+Posted results

Participant flow

MilestonePositive Affect TreatmentNegative Affect Treatment
Started4243
Week 5 assessment3637
Week 10 assessment3229
Completed3126
Not completed1117

Outcome results

  • Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) (Primary), Mean, score on a scale: Positive Affect Treatment 20.76 +/- 7.42; Negative Affect Treatment 29.42 +/- 4.74 (p .002)
  • Interviewer Anhedonia Ratings (Primary), Mean, score on a scale: Positive Affect Treatment 7.66 +/- 2.13; Negative Affect Treatment 7.47 +/- 1.80 (p >.05)
  • Depression Anxiety and Stress Scale (DASS-21) (Primary), Mean, score on a scale: Positive Affect Treatment 27.36 +/- 11.27; Negative Affect Treatment 24.51 +/- 10.54 (p .024)
  • Sheehan Disability Scale (SDS) (Secondary), Mean, score on a scale: Positive Affect Treatment 18.40 +/- 6.14; Negative Affect Treatment 16.65 +/- 6.51
  • Beck Depression Inventory (BDI) (Secondary), Mean, score on a scale: Positive Affect Treatment 0.17 +/- 0.38; Negative Affect Treatment 0.23 +/- 0.43
  • Daily Activity/Social Interaction (Actigraph) (Secondary), Mean, kcals expended per hour: Positive Affect Treatment 40.212 +/- 19.677; Negative Affect Treatment 34.634 +/- 24.427
  • Effort Expenditure for Rewards Task (EEfRT) (Secondary), Mean, proportion of high effort choices: Positive Affect Treatment 0.41 +/- 0.20; Negative Affect Treatment 0.41 +/- 0.27 (p .922)
  • Monetary Incentive Task (Secondary), Mean, beats/ms^2: Positive Affect Treatment -0.012 +/- 0.512; Negative Affect Treatment -0.017 +/- 0.046 (p .049)
  • Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) (Secondary), Mean, score on a scale: Positive Affect Treatment 9.67 +/- 2.63; Negative Affect Treatment 9.42 +/- 2.21 (p .591)
  • Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items (Secondary), Mean, score on a scale: Positive Affect Treatment 42.85 +/- 16.96; Negative Affect Treatment 49.16 +/- 16.32 (p .004)
  • Dimensional Anhedonia Rating Scale-Consummatory Items (Secondary), Mean, score on a scale: Positive Affect Treatment 17.56 +/- 6.26; Negative Affect Treatment 19.12 +/- 6.16 (p .030)
  • Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli (Secondary), Mean, milliseconds (ms): Positive Affect Treatment -43.43 +/- 114.62; Negative Affect Treatment 2.80 +/- 105.63 (p .029)
  • Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli (Secondary), Mean, milliseconds (ms): Positive Affect Treatment 9.30 +/- 105.87; Negative Affect Treatment 3.29 +/- 108.57
  • International Affective Picture System Task (Secondary), Mean, beats/ms^2: Positive Affect Treatment 0.0003 +/- 0.0243; Negative Affect Treatment -0.0007 +/- 0.0238 (p .494)
  • Temporal Experience of Pleasure Scale (Consummatory Subscale) (Secondary), Mean, score on a scale: Positive Affect Treatment 35.81 +/- 6.98; Negative Affect Treatment 37.12 +/- 6.03 (p .231)
  • Probabilistic Reward Task (PRT) (Secondary), Mean, Ratio: Positive Affect Treatment 0.16 +/- 0.19; Negative Affect Treatment 0.15 +/- 0.29 (p .344)
  • Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) (Secondary), Mean, volts: Positive Affect Treatment 6.30 +/- 12.29; Negative Affect Treatment 4.91 +/- 13.54 (p .267)
  • Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) (Secondary), Mean, score on a scale: Positive Affect Treatment 1.09 +/- 2.10; Negative Affect Treatment 0.62 +/- 2.17 (p .051)

Adverse events

Time frame: Each participant was assessed over 16 weeks

ArmDeathsSerious adverse eventsOther adverse events
Positive Affect Treatment0/42 (0.0%)0/42 (0.0%)0/42 (0.0%)
Negative Affect Treatment0/43 (0.0%)0/43 (0.0%)3/43 (7.0%)

Other adverse events by term

TermOrgan systemPositive Affect TreatmentNegative Affect Treatment
Clinical deteriorationPsychiatric disorders0/422/43
Homework noncompliance leading to participant withdrawalPsychiatric disorders0/421/43

Limitations and caveats: Generalizability from academic to community settings; Sample was selected to have low positive affect, thus results may not generalize to samples diagnosed with anhedonia; Lack of follow-up assessment prevented evaluation of long-term changes in target measures and outcomes; Sample powered for moderate or larger effects, while smaller effects may require larger samples; Participants not blinded to condition; NAT was not representative of typical cognitive-behavioral therapy for depression.

+Locations (2)

FacilityCityCountryStatus
University of California, Los AngelesLos Angeles, CaliforniaUnited States
Southern Methodist UniversityDallas, TexasUnited States

+Publications

  • Results publication: Uribe S, Kumar D, Rosenfield D, Ritz T, Meuret AE. From in-person to virtual: The impact of crisis-enforced delivery change on treatment for low positive affect, depression, and anxiety. J Affect Disord. 2025 Dec 15;391:119864. doi: 10.1016/j.jad.2025.119864. Epub 2025 Jul 11. PMID 40652976
  • Results publication: Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9. PMID 36892884

+Study documents

My Notes