Treatment for Affect Dimensions

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Negative Affect Treatment; Behavioral: Positive Affect Treatment

• Registration Number: NCT03439748
• Lead Sponsor: University of California, Los Angeles

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2019-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-07-20
• Results First Submitted QC: 2023-12-06
• Results First Posted: 2023-12-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Affect Treatment	Negative Affect Treatment	15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
Positive Affect Treatment	Positive Affect Treatment	15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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.
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.
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.
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.
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.
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.
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
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.
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.

Trial Locations

Locations (2)

Southern Methodist University; 🇺🇸 Dallas, Texas, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States