Treatment for Affect Dimensions

Among 81 studies in Depression by University of California, Los Angeles — 12 open to participants now, 12 under way, none of them phase 3. Depression · University of California, Los Angeles.

Enrollment

34th of 74

85 · median 76

Started

2019

with 1 other

No phase

45 of 81

7 open now

Registered

43rd of 81

by date

Among the 81 studies in Depression by University of California, Los Angeles, this one is the 34th largest by enrollment of the 74 interventional ones that give a count, is one of 2 that started in 2019, is one of 45 with no phase, and was the 43rd registered.

Browse trials for

• Depression 8,582
• Anxiety Disorders 7,207

Study arms

• Experimental
  Positive Affect Treatment

  15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

  Behavioral: Positive Affect Treatment

• Active comparator
  Negative Affect Treatment

  15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.

  Behavioral: Negative Affect Treatment

Interventions

• BehavioralPositive 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.

• BehavioralNegative 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 outcomes

1. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

2. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

3. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

Secondary outcomes

1. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

2. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

3. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

4. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

5. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

6. Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)

   Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity

   Time frame: Week 0, Week 5, Week 10, Week 16

7. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

8. Dimensional Anhedonia Rating Scale-Consummatory Items

   Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure.

   Time frame: Week 0, Week 5, Week 10, Week 16

9. 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.

   Time frame: Week 0, Week 5, Week 10, Week 16

10. 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.

    Time frame: Week 0, Week 5, Week 10, Week 16

11. 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.

    Time frame: Week 0, Week 5, Week 10, Week 16

12. 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

    Time frame: Week 0, Week 5, Week 10, Week 16

13. 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.

    Time frame: Week 0, Week 5, Week 10, Week 16

14. 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.

    Time frame: Week 0, Week 5, Week 10, Week 16

15. 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.

    Time frame: Week 0, Week 5, Week 10, Week 16

Baseline characteristics

11 further baseline measures are reported on the registry.

Study documents

• Protocol, analysis plan and consent form ↗ · Mar 31, 2022

PDFs hosted by the registry, ClinicalTrials.gov.