AnhedoniaNCT02498925
Examining Reward-Related Predictors and Mechanisms of Change in BA Treatment for Anhedonic Adolescents
A study testing Behavioral Activation in people with Anhedonia, run by Mclean Hospital at 1 site in United States.
Trial summary
The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e., 1-3%), but increases substantially during adolescence. By the age of 18, approximately 15% of adolescents will have experienced at least one episode of MDD. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to May 2023
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
General Inclusion Criteria:
- Both genders, any ethnicity
- Ages 13-18
- English as first language or English fluency
- Right handed
- Smartphone with iOS or Android platform (for EMA)
- Anhedonic Sample: Total Snaith Hamilton Pleasure Scale (SHAPS) score ≥ 3; Healthy Control Sample: Total SHAPS score = 0
General Exclusion Criteria:
- History of head trauma with loss of consciousness
- History of seizure disorder
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
- History of use of dopaminergic drugs (including methylphenidate)
- Clinical or laboratory evidence of hypothyroidism
- Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow
- Meet standard exclusion criteria for fMRI scanning (e.g. claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in their body);
- Positive urine pregnancy test
- Anhedonic Adolescents:
Additional Exclusion Criteria:
- Subjects with suicidal ideation where outpatient BA treatment is determined unsafe or inappropriate by the study clinician. These patients will be immediately referred to appropriate clinical treatment
- History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia spectrum or other psychotic disorder, bipolar disorder, OCD, PTSD, substance (including alcohol) use disorder within the past 12 months or lifetime severe substance use disorder (i.e., meeting former DSM-IV criteria for past substance dependence). Simple phobia, social anxiety disorder, panic disorder, and generalized anxiety disorder will be allowed only if secondary to anhedonia
- Meet criteria for chronic depression (current episode > 2 years)
- Currently receiving psychotropic treatment or psychotherapy
- Absence of any psychotropic medications: 8 weeks for fluoxetine, 4 weeks for neuroleptics, 8 weeks for benzodiazepines, 6 weeks any other antidepressants
- Healthy Control Adolescents:
Additional Exclusion Criteria:
- Elevated depressive symptoms as assessed in phone screen
- History of meeting criteria for any DSM-5 psychiatric or substance-related disorder
- Use of any psychiatric medications
- Family history (first-degree relatives) of any psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e., 1-3%), but increases substantially during adolescence. By the age of 18, approximately 15% of adolescents will have experienced at least one episode of MDD. A growing body of research implicates abnormalities in reward circuitry as playing a critical role in the development and maintenance of depressive symptoms in adolescents. Importantly, these reward-circuitry abnormalities have been linked to anhedonia (i.e., decreased pleasure or blunted reactivity to rewarding stimuli). Behavioral Activation (BA) represents a promising - and relatively simple to deliver - nonpharmacologic intervention for adolescent depression, which has been shown to be at least as effective as Cognitive Behavioral Therapy (CBT) with regards to symptom reduction and lowering the risk of relapse in adult samples. More recently, promising data have emerged from the application of BA to depressed adolescents. BA can be conceptualized as a treatment directly targeting anhedonia. More specifically, BA targets anhedonia through behavioral change strategies aimed at gradually increasing patients' exposure to and engagement with rewarding stimuli and positively reinforcing experiences. Given this treatment focus, BA may be particularly beneficial for adolescents struggling with relatively elevated levels of anhedonic symptoms. Accordingly, the present study will examine the role of anhedonia and reward functioning in predicting treatment response in BA. In addition, analyses will be conducted examining the reward-related neural and behavioral mechanisms underlying anhedonic symptom improvement in BA.
Read the detailed description
Participants in this research will include 35 anhedonic adolescents and 35 demographically matched healthy participants recruited from the greater Boston community by Dr. Webb at McLean Hospital's Center for Depression, Anxiety and Stress Research. The anhedonic adolescents will undergo 12 weeks of Behavioral Activation therapy. This study will include three sessions:
- The first session will involve a diagnostic interview, and a series of questionnaires and assessments.
- The second session will take place at the McLean Hospital's Neuroimaging Center, and involve an fMRI brain scan and administration of two behavioral tasks, as well as questionnaires.
- Following the 12-weeks treatment, anhedonic adolescents will return to McLean Hospital's Neuroimaging Center for an fMRI brain scan, two behavioral tasks, and questionnaires. The healthy control group will complete the same three assessments at corresponding time points.
- Conditions
- Anhedonia
- Being tested
- Behavioral Activation
- Medical subject headings
- Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Behavioral Activation is a psychosocial treatment for depression focused on gradually re-engaging patients with sources of reinforcement and reward in their environment (e.g., increasing activites and interpersonal interactions). In contrast to Cognitive Behavioral Therapy, and as the name implies, Behavioral Activation focuses on behavioral change strategies to improve mood and places little emphasis on cognitive restructuring techniques.
| Study group | Role | What they receive |
|---|---|---|
| Anhedonic teens receiving Behavioral Activation (BA) | Experimental | 12 weeks (1 50-min session per week) of Behavioral Activation for the anhedonic adolescents.
Behavioral Activation is a psychosocial treatment for depression focused on gradually re-engaging patients with sources of reinforcement and reward in their environment (e.g., increasing activites and interpersonal interactions). In contrast to Cognitive Behavioral Therapy, and as the name implies, Behavioral Activation focuses on behavioral strategies to improve mood and places little emphasis on cognitive restructuring techniques. Receives: Behavioral: Behavioral Activation |
| Non-anhedonic teens (not receiving BA) | No intervention | A group of adolescents with no anhedonia were recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anhedonic (Snaith-Hamilton Pleasure Scale; SHAPS) Symptoms
Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item questionnaire that measures the capacity to experience pleasure (lack of pleasure is referred to as anhedonia). Total scores range from 14-56 with higher scores reflecting more anhedonia
Measured: Change from pre-treatment (baseline) to post-treatment (12 weeks)
Change in Brain (Striatal and Medial PFC) Activation During a Monetary Reward Gambling Task
During the pre- and post-treatment fMRI scan, youth completed an event-related card- guessing task designed to assess brain responses to the anticipation and receipt of monetary reward and loss. The task included four 6.5-min blocks in which youth guessed whether the value of a card was higher or lower than 5. Based on the trial type (win, loss, neutral), youth won or lost money (win trials +$1.00, loss trails -$0.50, total earnings $16.00). We focused on neural response to win or loss (contrasted with neutral) outcomes. Individual contrast images were used to create second-level random effects models using one-sample t-tests for the win > neutral and loss > neutral contrasts. Mean beta weights for the medial PFC (mPFC) and striatal (NAcc, caudate, and putamen) regions of interest (ROIs) were extracted for each contrast. For details and results for each brain regions see Neuropsychopharmacology (2023) 48:623-632; https://doi.org/10.1038/s41386-022-01481-4
Measured: Change from pre-treatment (baseline) to post-treatment (12 weeks). Positive values reflect increases in neural response
Change in Performance (Reward Learning) on the Probabilistic Reward Task (PRT) Computer Task
Each PRT trial begins with a fixation cross (500 ms) followed by a cartoon face without either a mouth or a nose (counterbalanced across subjects and session). After a 500 ms delay, a short or long mouth/nose was presented (100 ms). Participants then indicated whether they saw a short or long mouth or nose. For each block, 40 trials with correct responses resulted in a monetary reward of $0.20. In these cases, participants were presented with a screen that said "Correct! You won 20 cents." While long and short mouths or noses were presented with equal frequency across the block, one length received a reward for correct identification 3x more frequently (i.e., rich stimulus; n=30) than the other (i.e., lean stimulus; n=10). Response bias favoring the rich stimulus was calculated using an established formula (see reference below for details). "Reward Learning" was calculated as the change in response bias score from block 1 to block 2. Higher scores reflect greater reward learning
Measured: Change in reward learning from pre-treatment (baseline) to post-treatment (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2022
- Study completionMay 2023
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 (4)Papers the sponsor has linked to this study.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Christian A. Webb, Mclean Hospital
- Investigators
- Christian A Webb, Ph.D., Principal investigator, McLean Hospital & McLean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498925
- Sponsor's protocol ID
- 2015-D000149
- Other IDs
- K23MH108752
- Status last verified
- Sep 2024
- First submitted
- 10 Jul 2015
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Webb CA, Murray L, Tierney AO, Forbes EE, Pizzagalli DA. Reward-related predictors of symptom change in behavioral activation therapy for anhedonic adolescents: a multimodal approach. Neuropsychopharmacology. 2023 Mar;48(4):623-632. doi: 10.1038/s41386-022-01481-4. Epub 2022 Oct 28.
PubMed 36307561Webb CA, Murray L, Tierney AO, Gates KM. Dynamic processes in behavioral activation therapy for anhedonic adolescents: Modeling common and patient-specific relations. J Consult Clin Psychol. 2024 Aug;92(8):454-465. doi: 10.1037/ccp0000830. Epub 2023 Jun 5.
PubMed 37276084Ren B, Balkind EG, Pastro B, Israel ES, Pizzagalli DA, Rahimi-Eichi H, Baker JT, Webb CA. Predicting states of elevated negative affect in adolescents from smartphone sensors: a novel personalized machine learning approach. Psychol Med. 2023 Aug;53(11):5146-5154. doi: 10.1017/S0033291722002161. Epub 2022 Jul 27.
PubMed 35894246Fisher H, Jaffe NM, Rahimi-Eichi H, Forbes EE, Pizzagalli DA, Baker JT, Webb CA. Measuring activation during behavioral activation therapy: a proof-of-concept study using smartphone sensors and LLM-derived ratings in adolescents with anhedonia. NPP Digit Psychiatry Neurosci. 2025 Oct 13;3:24. doi: 10.1038/s44277-025-00045-w. eCollection 2025.
PubMed 41098338
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Reward-Related Predictors and Mechanisms of Change in BA Treatment for Anhedonic Adolescents
- ClinicalTrials.gov ID
- NCT02498925
- Acronym / sponsor ID
- 2015-D000149
- Conditions
- Anhedonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2015 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of major depressive disorder (MDD) is relatively low in childhood (i.e., 1-3%), but increases substantially during adolescence. By the age of 18, approximately 15% of adolescents will have experienced at least one episode of MDD. A growing body of research implicates abnormalities in reward circuitry as playing a critical role in the development and maintenance of depressive symptoms in adolescents. Importantly, these reward-circuitry abnormalities have been linked to anhedonia (i.e., decreased pleasure or blunted reactivity to rewarding stimuli). Behavioral Activation (BA) represents a promising - and relatively simple to deliver - nonpharmacologic intervention for adolescent depression, which has been shown to be at least as effective as Cognitive Behavioral Therapy (CBT) with regards to symptom reduction and lowering the risk of relapse in adult samples. More recently, promising data have emerged from the application of BA to depressed adolescents. BA can be conceptualized as a treatment directly targeting anhedonia. More specifically, BA targets anhedonia through behavioral change strategies aimed at gradually increasing patients' exposure to and engagement with rewarding stimuli and positively reinforcing experiences. Given this treatment focus, BA may be particularly beneficial for adolescents struggling with relatively elevated levels of anhedonic symptoms. Accordingly, the present study will examine the role of anhedonia and reward functioning in predicting treatment response in BA. In addition, analyses will be conducted examining the reward-related neural and behavioral mechanisms underlying anhedonic symptom improvement in BA.
Detailed description
Participants in this research will include 35 anhedonic adolescents and 35 demographically matched healthy participants recruited from the greater Boston community by Dr. Webb at McLean Hospital's Center for Depression, Anxiety and Stress Research. The anhedonic adolescents will undergo 12 weeks of Behavioral Activation therapy. This study will include three sessions:
- The first session will involve a diagnostic interview, and a series of questionnaires and assessments.
- The second session will take place at the McLean Hospital's Neuroimaging Center, and involve an fMRI brain scan and administration of two behavioral tasks, as well as questionnaires.
- Following the 12-weeks treatment, anhedonic adolescents will return to McLean Hospital's Neuroimaging Center for an fMRI brain scan, two behavioral tasks, and questionnaires. The healthy control group will complete the same three assessments at corresponding time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anhedonic teens receiving Behavioral Activation (BA) | Experimental | Behavioral: Behavioral Activation12 weeks (1 50-min session per week) of Behavioral Activation for the anhedonic adolescents. Behavioral Activation is a psychosocial treatment for depression focused on gradually re-engaging patients with sources of reinforcement and reward in their environment (e.g., increasing activites and interpersonal interactions). In contrast to Cognitive Behavioral Therapy, and as the name implies, Behavioral Activation focuses on behavioral strategies to improve mood and places little emphasis on cognitive restructuring techniques. |
| Non-anhedonic teens (not receiving BA) | No intervention | –A group of adolescents with no anhedonia were recruited |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Behavioral ActivationBehavioral Activation is a psychosocial treatment for depression focused on gradually re-engaging patients with sources of reinforcement and reward in their environment (e.g., increasing activites and interpersonal interactions). In contrast to Cognitive Behavioral Therapy, and as the name implies, Behavioral Activation focuses on behavioral change strategies to improve mood and places little emphasis on cognitive restructuring techniques. | Behavioural | Anhedonic teens receiving Behavioral Activation (BA) |
Primary outcome
Change in Anhedonic (Snaith-Hamilton Pleasure Scale; SHAPS) Symptoms
Time frame: Change from pre-treatment (baseline) to post-treatment (12 weeks)
Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item questionnaire that measures the capacity to experience pleasure (lack of pleasure is referred to as anhedonia). Total scores range from 14-56 with higher scores reflecting more anhedonia
Change in Brain (Striatal and Medial PFC) Activation During a Monetary Reward Gambling Task
Time frame: Change from pre-treatment (baseline) to post-treatment (12 weeks). Positive values reflect increases in neural response
During the pre- and post-treatment fMRI scan, youth completed an event-related card- guessing task designed to assess brain responses to the anticipation and receipt of monetary reward and loss. The task included four 6.5-min blocks in which youth guessed whether the value of a card was higher or lower than 5. Based on the trial type (win, loss, neutral), youth won or lost money (win trials +$1.00, loss trails -$0.50, total earnings $16.00). We focused on neural response to win or loss (contrasted with neutral) outcomes. Individual contrast images were used to create second-level random effects models using one-sample t-tests for the win > neutral and loss > neutral contrasts. Mean beta weights for the medial PFC (mPFC) and striatal (NAcc, caudate, and putamen) regions of interest (ROIs) were extracted for each contrast. For details and results for each brain regions see Neuropsychopharmacology (2023) 48:623-632; https://doi.org/10.1038/s41386-022-01481-4
Change in Performance (Reward Learning) on the Probabilistic Reward Task (PRT) Computer Task
Time frame: Change in reward learning from pre-treatment (baseline) to post-treatment (12 weeks).
Each PRT trial begins with a fixation cross (500 ms) followed by a cartoon face without either a mouth or a nose (counterbalanced across subjects and session). After a 500 ms delay, a short or long mouth/nose was presented (100 ms). Participants then indicated whether they saw a short or long mouth or nose. For each block, 40 trials with correct responses resulted in a monetary reward of $0.20. In these cases, participants were presented with a screen that said "Correct! You won 20 cents." While long and short mouths or noses were presented with equal frequency across the block, one length received a reward for correct identification 3x more frequently (i.e., rich stimulus; n=30) than the other (i.e., lean stimulus; n=10). Response bias favoring the rich stimulus was calculated using an established formula (see reference below for details). "Reward Learning" was calculated as the change in response bias score from block 1 to block 2. Higher scores reflect greater reward learning
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36307561Webb CA, Murray L, Tierney AO, Forbes EE, Pizzagalli DA. Reward-related predictors of symptom change in behavioral activation therapy for anhedonic adolescents: a multimodal approach. Neuropsychopharmacology. 2023 Mar;48(4):623-632. doi: 10.1038/s41386-022-01481-4. Epub 2022 Oct 28.
- Results publication: PubMed 37276084Webb CA, Murray L, Tierney AO, Gates KM. Dynamic processes in behavioral activation therapy for anhedonic adolescents: Modeling common and patient-specific relations. J Consult Clin Psychol. 2024 Aug;92(8):454-465. doi: 10.1037/ccp0000830. Epub 2023 Jun 5.
- Results publication: PubMed 35894246Ren B, Balkind EG, Pastro B, Israel ES, Pizzagalli DA, Rahimi-Eichi H, Baker JT, Webb CA. Predicting states of elevated negative affect in adolescents from smartphone sensors: a novel personalized machine learning approach. Psychol Med. 2023 Aug;53(11):5146-5154. doi: 10.1017/S0033291722002161. Epub 2022 Jul 27.
- Derived from this study: PubMed 41098338Fisher H, Jaffe NM, Rahimi-Eichi H, Forbes EE, Pizzagalli DA, Baker JT, Webb CA. Measuring activation during behavioral activation therapy: a proof-of-concept study using smartphone sensors and LLM-derived ratings in adolescents with anhedonia. NPP Digit Psychiatry Neurosci. 2025 Oct 13;3:24. doi: 10.1038/s44277-025-00045-w. eCollection 2025.
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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.
Christian A Webb, Ph.D. principal investigator
McLean Hospital & McLean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Anhedonia, run by Mclean Hospital 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?
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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). 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?
Change in Anhedonic (Snaith-Hamilton Pleasure Scale; SHAPS) Symptoms (time frame: Change from pre-treatment (baseline) to post-treatment (12 weeks)). 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 NCT02498925, which also lists 4 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 19 Sep 2024.