DepressionNCT05203861
Affect Treatment for Depression and Anxiety
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 mediators of change in 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
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Nov 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, cognitive impairment, or organic brain damage
- Substance abuse in the last 6 months or dependence within last 12 months.
- Greater than 11 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 12Show fewer
- Willingness to refrain from marijuana use 1 week before laboratory assessments
- Pregnancy
- Bupropion, dopaminergic or neuroleptic medications 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
- Prior participation in previous waves of this study
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 and Threat Sensitivity as Mediators of Positive and Negative Affect Treatment
The purpose of this study is to evaluate the efficacy and mediators of change in 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 100 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 5 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 a replication and extension of a prior NIMH funded R61 phase trial, the purpose of this R33 phase randomized controlled trial is to evaluate the efficacy and mediators of change of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Mediators (targets) include behavioral, cognitive, physiological and experiential measures of two reward targets: reward anticipation and response to reward attainment. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity, and by including behavioral, cognitive, physiological and experiential mediators (targets) that assess threat sensitivity.
Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, Week 16 (post), and one-month follow-up. Mediators (targets) are assessed at baseline, Week 5, Week 10, Week 16 (post) and one-month follow-up. Mediational models will evaluate the degree to which change in the target measures explain change in the outcome measures.
Target enrollment is 100 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 5 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 and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)
Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50, higher scores represent higher levels of positive affect or negative affect).
Measured: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Depression Anxiety and Stress Scale (DASS-21)
Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.
Measured: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Secondary outcomes (14)
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: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
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.
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Beck Scale for Suicide Ideation
Reported suicidal ideation (score range: 0-38), higher scores indicate higher suicidality
Measured: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
Positive and Negative Affect Schedule Expanded (PANAS-X) Basic Positive Emotions Scales and Serenity
Mediator: Reported positive affect (basic positive emotions scales and serenity) (score range: 19 - 95). Note: items which overlap with the general dimensions scale for positive affect (see Outcome 1) will not be included in this composite score. Excluded overlapping items include: alert, attentive, determined, enthusiastic, excited, proud, and strong.
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Effort-Expenditure for Rewards Task (EEfRT)
Mediator: behavioral effort for reward
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Monetary Incentive Task
Mediator: cardiac acceleration to anticipation of reward
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Mediator: Reported reward sensitivity (score range: 4-16), and threat sensitivity (score range: 7-28), with higher scores indicating higher sensitivity
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Dimensional Anhedonia Rating Scale
Mediator: Reported reward desire, motivation, effort, and pleasure (score range: 0-68), with higher scores indicating higher degree of reward desire, motivation, effort, and pleasure
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Modified Attentional Dot Probe Task
Mediator: attentional engagement with positive and negative stimuli
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
International Affective Picture System Task
Mediator: cardiac response to positive stimuli
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Temporal Experience of Pleasure Scale (consummatory subscale)
Mediator: Reported reward consummatory pleasure (score range: 8-48)
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Anxiety Sensitivity Index
Mediator: Reported threat appraisal of anxiety (score range: 0-64)
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Probability and Cost Questionnaire for Social and Physical Outcomes
Mediator: Reported threat appraisal of social and physical outcomes (score range: 0-80 for each subscale), with higher scores indicating higher cost/probability estimation
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Mental Arithmetic Task
Mediator: cardiorespiratory response to stress
Measured: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start22 Nov 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 100 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
- NCT05203861
- Sponsor's protocol ID
- R33MH115138
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meuret AE, Rosenfield D, Wang E, Hough CM, Ritz T, Craske MG. Positive Affect Treatment for Depression, Anxiety, and Low Positive Affect: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e267403. doi: 10.1001/jamanetworkopen.2026.7403.
PubMed 42030048
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward and Threat Sensitivity as Mediators of Positive and Negative Affect Treatment
- ClinicalTrials.gov ID
- NCT05203861
- Acronym / sponsor ID
- R33MH115138
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Southern Methodist University
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
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 mediators of change in 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 100 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 5 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 a replication and extension of a prior NIMH funded R61 phase trial, the purpose of this R33 phase randomized controlled trial is to evaluate the efficacy and mediators of change of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Mediators (targets) include behavioral, cognitive, physiological and experiential measures of two reward targets: reward anticipation and response to reward attainment. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity, and by including behavioral, cognitive, physiological and experiential mediators (targets) that assess threat sensitivity.
Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, Week 16 (post), and one-month follow-up. Mediators (targets) are assessed at baseline, Week 5, Week 10, Week 16 (post) and one-month follow-up. Mediational models will evaluate the degree to which change in the target measures explain change in the outcome measures.
Target enrollment is 100 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 5 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 (12 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, cognitive impairment, or organic brain damage
- Substance abuse in the last 6 months or dependence within last 12 months.
- Greater than 11 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 and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)
Time frame: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50, higher scores represent higher levels of positive affect or negative affect).
Depression Anxiety and Stress Scale (DASS-21)
Time frame: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.
14 secondary outcomes
Interviewer Anhedonia Ratings
Time frame: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
Sheehan Disability Scale (SDS)
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Beck Scale for Suicide Ideation
Time frame: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
Positive and Negative Affect Schedule Expanded (PANAS-X) Basic Positive Emotions Scales and Serenity
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Effort-Expenditure for Rewards Task (EEfRT)
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Monetary Incentive Task
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Dimensional Anhedonia Rating Scale
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Modified Attentional Dot Probe Task
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
International Affective Picture System Task
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Temporal Experience of Pleasure Scale (consummatory subscale)
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Anxiety Sensitivity Index
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Probability and Cost Questionnaire for Social and Physical Outcomes
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Mental Arithmetic Task
Time frame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Derived from this study: PubMed 42030048Meuret AE, Rosenfield D, Wang E, Hough CM, Ritz T, Craske MG. Positive Affect Treatment for Depression, Anxiety, and Low Positive Affect: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e267403. doi: 10.1001/jamanetworkopen.2026.7403.
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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 12 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 25 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales) (time frame: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)). The study lists 2 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 NCT05203861, which also lists 1 linked publication.
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 25 Apr 2025.