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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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)
Show all 10Show fewer
- 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
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 group | Role | What they receive |
|---|---|---|
| Positive Affect Treatment | Experimental | 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Receives: Behavioral: Positive Affect Treatment |
| Negative Affect Treatment | Active comparator | 15 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.
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted20 Feb 2018
- Study start1 Feb 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Methodist University
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 40652976Craske 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Sensitivity as a Mechanism of Positive Affect Treatment
- ClinicalTrials.gov ID
- NCT03439748
- Acronym / sponsor ID
- TAD / R61MH115138
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Southern Methodist University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Affect Treatment | Experimental | Behavioral: Positive Affect Treatment15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
| Negative Affect Treatment | Active comparator | Behavioral: Negative Affect Treatment15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Affect TreatmentSessions 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. | Behavioural | Positive Affect Treatment |
| Negative Affect TreatmentSessions 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 | Behavioural | Negative Affect Treatment |
Primary outcome
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Time frame: 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
Time frame: 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)
Time frame: 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.
15 secondary outcomes
Sheehan Disability Scale (SDS)
Time frame: Week 0, Week 5, Week 10, Week 16
Beck Depression Inventory (BDI)
Time frame: Week 0, Week 5, Week 10, Week 16
Daily Activity/Social Interaction (Actigraph)
Time frame: Week 0, Week 5, Week 10, Week 16
Effort Expenditure for Rewards Task (EEfRT)
Time frame: Week 0, Week 5, Week 10, Week 16
Monetary Incentive Task
Time frame: Week 0, Week 5, Week 10, Week 16
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Time frame: Week 0, Week 5, Week 10, Week 16
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Time frame: Week 0, Week 5, Week 10, Week 16
Dimensional Anhedonia Rating Scale-Consummatory Items
Time frame: Week 0, Week 5, Week 10, Week 16
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
Time frame: Week 0, Week 5, Week 10, Week 16
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
Time frame: Week 0, Week 5, Week 10, Week 16
International Affective Picture System Task
Time frame: Week 0, Week 5, Week 10, Week 16
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Time frame: Week 0, Week 5, Week 10, Week 16
Probabilistic Reward Task (PRT)
Time frame: Week 0, Week 5, Week 10, Week 16
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
Time frame: Week 0, Week 5, Week 10, Week 16
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Time frame: Week 0, Week 5, Week 10, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40652976Uribe 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.
- Derived from this study: PubMed 36892884Craske 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.
Related trials for Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.