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| Name | Class |
|---|---|
| Southern Methodist University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Affect Treatment | Experimental | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
|
| Negative Affect Treatment | Active Comparator | 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. | Week 0, Week 5, Week 10, Week 16 |
| Interviewer Anhedonia Ratings | Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia. | Week 0, Week 5, Week 10, Week 16 |
| Depression Anxiety and Stress Scale (DASS-21) | Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency. | Week 0, Week 5, Week 10, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan Disability Scale (SDS) | 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. | Week 0, Week 5, Week 10, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Southern Methodist University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652976 | Derived | 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. | |
| 36892884 | Derived | 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. |
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1062 individuals completed an online screening. 517 were excluded due to ineligibility and 114 did not follow up. 431 were scheduled for a phone screen. 27 declined, 131 were excluded due to ineligibility, and 60 could not be reached. The remaining 213 were scheduled for a diagnostic assessment. 30 declined to participate, 46 were excluded due to ineligibility or other reasons, and 45 could not be reached. 92 participants were eligible. 7 withdrew during or after assessment. 85 were randomized.
Recruitment began February 23, 2019 and ended February 5, 2021. A brief study description was distributed via lab websites, social media, ClinicalTrials.gov, and campus and local area flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Affect Treatment | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Positive Affect Treatment: 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. |
| FG001 | Negative Affect Treatment | 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. Negative Affect Treatment: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Affect Treatment | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Positive Affect Treatment: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
Each participant was assessed over 16 weeks
DSMB committee members independently evaluated whether each event qualified as a serious adverse event using the following criteria: 1) Serious/Not serious: Is the event serious or places subjects or others at greater risk than previously known or recognized? 2) Expected/Unexpected: Is the event unexpected (not described in the protocol or consent or exceeds severity/frequency of expected event) 3) Causality: Is the event-related or possibly related to research procedures?
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Affect Treatment | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Positive Affect Treatment: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical deterioration | Psychiatric disorders | Non-systematic Assessment | Two participants experienced clinical deterioration during treatment. For both, the team decided that the participant's therapist would go off-protocol following session 10 in order to best address the participant's current mental health needs. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle G. Craske | UCLA | (310) 825-8403 | mcraske@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 31, 2022 | Apr 12, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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|
| 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 |
|
| Beck Depression Inventory (BDI) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Daily Activity/Social Interaction (Actigraph) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Effort Expenditure for Rewards Task (EEfRT) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Monetary Incentive Task | 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. | Week 0, Week 5, Week 10, Week 16 |
| Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity | Week 0, Week 5, Week 10, Week 16 |
| Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort. | Week 0, Week 5, Week 10, Week 16 |
| Dimensional Anhedonia Rating Scale-Consummatory Items | Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure. | Week 0, Week 5, Week 10, Week 16 |
| Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | 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. | Week 0, Week 5, Week 10, Week 16 |
| Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | 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. | Week 0, Week 5, Week 10, Week 16 |
| International Affective Picture System Task | 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. | Week 0, Week 5, Week 10, Week 16 |
| Temporal Experience of Pleasure Scale (Consummatory Subscale) | Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure | Week 0, Week 5, Week 10, Week 16 |
| Probabilistic Reward Task (PRT) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | 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. | Week 0, Week 5, Week 10, Week 16 |
| Dallas |
| Texas |
| 75205 |
| United States |
| BG001 | Negative Affect Treatment | 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. Negative Affect Treatment: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Current psychotropic medication | Count of Participants | Participants |
|
| Any diagnosis | Count of Participants | Participants |
|
| Depressive diagnoses | Count of Participants | Participants |
|
| Major depressive disorder | Count of Participants | Participants |
|
| Persistent depressive disorder | Count of Participants | Participants |
|
| Anxiety diagnoses | Count of Participants | Participants |
|
| Panic disorder | Count of Participants | Participants |
|
| Agoraphobia | Count of Participants | Participants |
|
| Social anxiety disorder | Count of Participants | Participants |
|
| Generalized anxiety disorder | Count of Participants | Participants |
|
| Specific phobia | Count of Participants | Participants |
|
| Posttraumatic stress disorder | Count of Participants | Participants |
|
| Obsessive compulsive disorder | Count of Participants | Participants |
|
| Attention deficit hyperactivity | Count of Participants | Participants |
|
| Adjustment disorder | Count of Participants | Participants |
|
| OG001 | Negative Affect Treatment | 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. Negative Affect Treatment: 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 |
|
|
|
| Primary | Interviewer Anhedonia Ratings | Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Primary | Depression Anxiety and Stress Scale (DASS-21) | Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Sheehan Disability Scale (SDS) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
| Secondary | Beck Depression Inventory (BDI) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
| Secondary | Daily Activity/Social Interaction (Actigraph) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | kcals expended per hour | Week 0, Week 5, Week 10, Week 16 |
|
|
|
| Secondary | Effort Expenditure for Rewards Task (EEfRT) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | proportion of high effort choices | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Monetary Incentive Task | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | beats/ms^2 | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Dimensional Anhedonia Rating Scale-Consummatory Items | Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | milliseconds (ms) | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | milliseconds (ms) | Week 0, Week 5, Week 10, Week 16 |
|
|
|
| Secondary | International Affective Picture System Task | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | beats/ms^2 | Week 0, Week 5, Week 10, Week 16 |
|
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|
|
| Secondary | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Probabilistic Reward Task (PRT) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | Ratio | Week 0, Week 5, Week 10, Week 16 |
|
|
|
|
| Secondary | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | volts | Week 0, Week 5, Week 10, Week 16 |
|
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|
|
| Secondary | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | 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. | Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment) | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 5, Week 10, Week 16 |
|
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Negative Affect Treatment | 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. Negative Affect Treatment: 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 | 0 | 43 | 0 | 43 | 3 | 43 |
|
| Homework noncompliance leading to participant withdrawal | Psychiatric disorders | Non-systematic Assessment | Participant did not complete homework for NAT sessions 5-11. Participant also expressed ambivalence about completing CART protocol between sessions. Following introduction of CART protocol, they expressed that they would like to terminate services. |
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| Week 10 |
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| Week 16 |
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| Week 5 |
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| Week 10 |
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| Week 16 |
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| Week 5 |
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| Week 10 |
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| Week 16 |
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| Week 5 |
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| Week 10 |
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| Week 16 |
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| Week 5 |
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| Week 10 |
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| Week 16 |
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| Week 5 |
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| Week 10 |
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| Week 16 |
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