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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH108752 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Non-anhedonic teens (not receiving BA) | No Intervention | A group of adolescents with no anhedonia were recruited |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 |
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General Inclusion Criteria:
General Exclusion Criteria:
A. Anhedonic Adolescents:
Additional Exclusion Criteria:
B. Healthy Control Adolescents:
Additional Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian A Webb, Ph.D. | McLean Hospital & McLean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36307561 | Result | 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. | |
| 37276084 | Result | Webb 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation | 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. Behavioral Activation: 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. |
| FG001 | Non-anhedonic Adolescents | Non-anhedonic (healthy control) adolescents who did not receive behavioral activation (BA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
39 anhedonic and 41 non-anhedonic
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| ID | Title | Description |
|---|---|---|
| BG000 | Anhedonic Adolescents Receiving Behavioral Activation | 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. Behavioral Activation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants who completed pre- and post-treatment SHAPS (and corresponding timepoints for non-anhedonic control group who did not receive BA treatment) | Posted | Mean | Standard Deviation | units on SHAPS scale | Change from pre-treatment (baseline) to post-treatment (12 weeks) |
|
12 week behavioral activation trial with 6-month and 1-year follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Activation | 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. Behavioral Activation: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment | One anhedonic teen attempted suicide (first lifetime attempt) prior to receiving any BA sessions (and was referred to a higher level of psychiatric care after discussions with the study team and participating parents). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Webb, PhD | McLean Hospital | 6178554429 | cwebb@mclean.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Nov 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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|
| Change in reward learning from pre-treatment (baseline) to post-treatment (12 weeks). |
| 35894246 | Result | Ren 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. |
| 41098338 | Derived | Fisher 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. |
| BG001 | Non-Anhedonic Adolescents | Adolescents without anhedonia (healthy controls) who did not receive behavioral activation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Snaith-Hamilton Pleasure Scale (SHAPS) | A measure of anhedonia | Mean | Standard Deviation | SHAPS total score |
|
| OG001 | Non-anhedonic Adolescent Control Group | Non-anhedonic (healthy control) adolescents who did not receive behavioral activation |
|
|
| Primary | 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 | Participants who completed both baseline and post-treatment fMRI scan (corresponding timepoints for non-anhedonic group). See Neuropsychopharmacology (2023) 48:623-632; https://doi.org/10.1038/s41386-022-01481-4 | Posted | Mean | Standard Deviation | Mean beta weights for ROI win > neutral | Change from pre-treatment (baseline) to post-treatment (12 weeks). Positive values reflect increases in neural response |
|
|
|
| Primary | 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 | Participants with usable (passed quality control and not lost due to start of COVID) PRT data at pre- and post-assessment. See Webb et al, Neuropsychopharmacology (2023) 48:623-632; https://doi.org/10.1038/s41386-022-01481-4 | Posted | Mean | Standard Deviation | reward learning score | Change in reward learning from pre-treatment (baseline) to post-treatment (12 weeks). |
|
|
|
| 0 |
| 80 |
| 2 |
| 80 |
| 0 |
| 80 |
|
| Seizure | Nervous system disorders | Non-systematic Assessment | One anhedonic teen in the treatment arm experienced a seizure at home |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| medial pfc |
|