AnhedoniaNCT05383248
Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
A study testing High Reward - High Variance and High Reward - Low Variance in people with Anhedonia and Depression, run by University of California, San Diego at 1 site in United States.
Trial summary
Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders. Untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anhedonia, Depression
- What is being tested?
- High Reward - High Variance and High Reward - Low Variance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 16 Nov 2023
- 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
- Age 18-65 (all races, both males and females will be included)
- Current diagnosis of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD)
- A score < 7 on the Snaith-Hamilton Pleasure Scale (SHAPS) or < 25 on the Positive Affect subscale from the Positive And Negative Affect Scale (PANAS)
- Sufficient proficiency in English language to understand and complete informed consent, interviews, questionnaires, and all other study procedures.
- Having normal or corrected vision
- Having normal or corrected hearing
Who cannot join
- Endorsement of past or current psychotic or bipolar disorder.
- Endorsement of recent severe alcohol or substance use disorder (past 3 months).
- Inability to discontinue for 48 hours prior to scan any medications incompatible with measuring reliable/interpretable neural activity (e.g., e.g., benzodiazepines/beta-blockers, atypical anti-depressants, anxiolytics and sedative hypnotics, antipsychotics, and opioid analgesics)
- Being unsafe to undergo functional magnetic resonance imaging (fMRI), i.e., being pregnant, presence of non-removable metal in body, medical conditions that are incompatible with safe MRI (e.g., claustrophobia, inability to lie still on one's back for approximately 60 minutes; prior neurosurgery)
- Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation): These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Center for Functional Magnetic Resonance Imaging
La Jolla, California, 92093
About this study
Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders. Untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia are fraught with poor patient compliance in real-life settings. The proposed study aims to address this gap by 1) testing the usefulness of a non-invasive, computationally informed, cognitive training in boosting reward sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the neurocomputational mechanisms of change associated with such intervention. In other words, can we train the brain to obtain rewards and boost positive mood among depressed and anxious individuals? This project will help to develop a computational training protocol aimed at reducing anhedonia and improving existing interventions for psychiatric conditions characterized by reward processing deficits. Long-term goals include expanding this framework to a broader range of appetitive and social stimuli to develop precise cognitive training tools to treat anhedonia.
- Conditions
- Anhedonia, Depression
- Being tested
- High Reward - High Variance, High Reward - Low Variance
- Medical subject headings
- Anhedonia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Reward - High VarianceBehavioural
Computerized reward learning task designed to increase reward responsiveness
High Reward - Low VarianceBehavioural
Computerized reward learning task designed to have minimal effect on reward responsiveness
| Study group | Role | What they receive |
|---|---|---|
| High Reward - High Variance | Experimental | Not described Receives: Behavioral: High Reward - High Variance |
| High Reward - Low Variance | Active comparator | Not described Receives: Behavioral: High Reward - Low Variance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward Maximization
Individually fitted computational parameter of reward maximization strategy during the reward learning task
Measured: Change between Pre-Training and Post-Training Assessments (about 20 min)
Positive Affect
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
Measured: Change between Pre-Training and Post-Training Assessments (about 20 min)
Neural Tracking of Reward Expectation
Neural activity, i.e., blood oxygen level dependent (BOLD) response, in the striatum and medial prefrontal cortex correlating with participants' trial-level model-based reward expectations and associated prediction errors during the Reward Learning Task
Measured: Change between Pre-Training and Post-Training Assessments (about 20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start14 Sep 2022
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
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 AnhedoniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katia Harle, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383248
- Sponsor's protocol ID
- 309646-00001
- Status last verified
- Nov 2023
- First submitted
- 16 May 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harle KM, Stein MB, Simmons AN, Taylor CT. Neurocomputational training to boost reward learning and sensitivity in anhedonic individuals: a transdiagnostic proof-of-concept trial. Transl Psychiatry. 2026 Aug 3;16(1):600. doi: 10.1038/s41398-026-04355-1.
PubMed 42957618
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Cognitive Training To Boost Reward Responsiveness In Anhedonic Patients
- ClinicalTrials.gov ID
- NCT05383248
- Acronym / sponsor ID
- 309646-00001
- Conditions
- Anhedonia, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 20 May 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.
Anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders. Untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia are fraught with poor patient compliance in real-life settings. The proposed study aims to address this gap by 1) testing the usefulness of a non-invasive, computationally informed, cognitive training in boosting reward sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the neurocomputational mechanisms of change associated with such intervention. In other words, can we train the brain to obtain rewards and boost positive mood among depressed and anxious individuals? This project will help to develop a computational training protocol aimed at reducing anhedonia and improving existing interventions for psychiatric conditions characterized by reward processing deficits. Long-term goals include expanding this framework to a broader range of appetitive and social stimuli to develop precise cognitive training tools to treat anhedonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Reward - High Variance | Experimental | Behavioral: High Reward - High Variance |
| High Reward - Low Variance | Active comparator | Behavioral: High Reward - Low Variance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 (all races, both males and females will be included)
- Current diagnosis of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD)
- A score < 7 on the Snaith-Hamilton Pleasure Scale (SHAPS) or < 25 on the Positive Affect subscale from the Positive And Negative Affect Scale (PANAS)
- Sufficient proficiency in English language to understand and complete informed consent, interviews, questionnaires, and all other study procedures.
- Having normal or corrected vision
Key exclusion criteria (5 listed)
- Endorsement of past or current psychotic or bipolar disorder.
- Endorsement of recent severe alcohol or substance use disorder (past 3 months).
- Inability to discontinue for 48 hours prior to scan any medications incompatible with measuring reliable/interpretable neural activity (e.g., e.g., benzodiazepines/beta-blockers, atypical anti-depressants, anxiolytics and sedative hypnotics, antipsychotics, and opioid analgesics)
- Being unsafe to undergo functional magnetic resonance imaging (fMRI), i.e., being pregnant, presence of non-removable metal in body, medical conditions that are incompatible with safe MRI (e.g., claustrophobia, inability to lie still on one's back for approximately 60 minutes; prior neurosurgery)
- Clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation): These criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
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 |
|---|---|---|
| High Reward - High VarianceComputerized reward learning task designed to increase reward responsiveness | Behavioural | High Reward - High Variance |
| High Reward - Low VarianceComputerized reward learning task designed to have minimal effect on reward responsiveness | Behavioural | High Reward - Low Variance |
Primary outcome
Reward Maximization
Time frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
Individually fitted computational parameter of reward maximization strategy during the reward learning task
Positive Affect
Time frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
State positive affect measured with the Positive and Negative Affect Schedule (PANAS)
Neural Tracking of Reward Expectation
Time frame: Change between Pre-Training and Post-Training Assessments (about 20 min)
Neural activity, i.e., blood oxygen level dependent (BOLD) response, in the striatum and medial prefrontal cortex correlating with participants' trial-level model-based reward expectations and associated prediction errors during the Reward Learning Task
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 29 Nov 2023.
- Derived from this study: PubMed 42957618Harle KM, Stein MB, Simmons AN, Taylor CT. Neurocomputational training to boost reward learning and sensitivity in anhedonic individuals: a transdiagnostic proof-of-concept trial. Transl Psychiatry. 2026 Aug 3;16(1):600. doi: 10.1038/s41398-026-04355-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Reward - High Variance and High Reward - Low Variance in people with Anhedonia and Depression, run by University of California, San Diego at 1 site 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 6 inclusion and 5 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reward Maximization (time frame: Change between Pre-Training and Post-Training Assessments (about 20 min)). 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 NCT05383248, 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 29 Nov 2023.