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DepressionTADNCT03439748

Treatment for Affect Dimensions

A study testing Positive Affect Treatment and Negative Affect Treatment in people with Depression and Anxiety, run by University of California, Los Angeles at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression, Anxiety
What is being tested?
Positive Affect Treatment and Negative Affect Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesUnited States
Study dates
1 Feb 2019to 30 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Southern Methodist University

    Dallas, Texas, 75205

  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Reward Sensitivity as a Mechanism of Positive Affect Treatment

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.

Read the 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.

Conditions
Depression, Anxiety
Being tested
Positive Affect Treatment, Negative Affect Treatment
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Affect TreatmentBehavioural

    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 TreatmentBehavioural

    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

Study groups in NCT03439748
Study groupRoleWhat they receive
Positive Affect TreatmentExperimental15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Receives: Behavioral: Positive Affect Treatment
Negative Affect TreatmentActive comparator15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
Receives: Behavioral: Negative Affect Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Week 0, Week 5, Week 10, Week 16

Secondary outcomes (15)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Week 0, Week 5, Week 10, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start1 Feb 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03439748
Sponsor's protocol ID
R61MH115138
Acronym
TAD
Status last verified
Jun 2024
First submitted
5 Feb 2018
Last updated
12 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40652976
  • 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.

    PubMed 36892884

Questions about this trial

What is this clinical trial studying?

A study testing Positive Affect Treatment and Negative Affect Treatment in people with Depression and Anxiety, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) (time frame: Week 0, Week 5, Week 10, Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03439748, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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Treatment for Affect Dimensions (NCT03439748) | AzTrials