Trial Outcomes & Findings for Examining Reward-Related Predictors and Mechanisms of Change in BA Treatment for Anhedonic Adolescents (NCT NCT02498925)

Last Updated: 2024-09-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Change from pre-treatment (baseline) to post-treatment (12 weeks)

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Non-anhedonic Adolescents Non-anhedonic (healthy control) adolescents who did not receive behavioral activation (BA)
Overall Study STARTED	39	41
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining Reward-Related Predictors and Mechanisms of Change in BA Treatment for Anhedonic Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anhedonic Adolescents Receiving Behavioral Activation n=39 Participants 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.	Non-Anhedonic Adolescents n=41 Participants Adolescents without anhedonia (healthy controls) who did not receive behavioral activation	Total n=80 Participants Total of all reporting groups
Age, Continuous	15.7 years STANDARD_DEVIATION 1.9 • n=5 Participants	16.2 years STANDARD_DEVIATION 1.7 • n=7 Participants	15.9 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	41 participants n=7 Participants	80 participants n=5 Participants
Snaith-Hamilton Pleasure Scale (SHAPS)	36.18 SHAPS total score STANDARD_DEVIATION 5.85 • n=5 Participants	17.85 SHAPS total score STANDARD_DEVIATION 3.91 • n=7 Participants	26.79 SHAPS total score STANDARD_DEVIATION 10.45 • n=5 Participants

PRIMARY outcome

Timeframe: Change from pre-treatment (baseline) to post-treatment (12 weeks)

Population: Participants who completed pre- and post-treatment SHAPS (and corresponding timepoints for non-anhedonic control group who did not receive BA treatment)

Outcome measures

Outcome measures
Measure	Behavioral Activation n=34 Participants 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.	Non-anhedonic Adolescent Control Group n=35 Participants Non-anhedonic (healthy control) adolescents who did not receive behavioral activation
Change in Anhedonic (Snaith-Hamilton Pleasure Scale; SHAPS) Symptoms	7.06 units on SHAPS scale Standard Deviation 8.65	-1.29 units on SHAPS scale Standard Deviation 3.57

PRIMARY outcome

Timeframe: Change from pre-treatment (baseline) to post-treatment (12 weeks). Positive values reflect increases in neural response

Population: 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

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

Outcome measures

Outcome measures
Measure	Behavioral Activation n=31 Participants 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.	Non-anhedonic Adolescent Control Group n=32 Participants Non-anhedonic (healthy control) adolescents who did not receive behavioral activation
Change in Brain (Striatal and Medial PFC) Activation During a Monetary Reward Gambling Task right striatrum	0.35 Mean beta weights for ROI win > neutral Standard Deviation 1.41	-0.31 Mean beta weights for ROI win > neutral Standard Deviation 1.01
Change in Brain (Striatal and Medial PFC) Activation During a Monetary Reward Gambling Task left striatum	-0.04 Mean beta weights for ROI win > neutral Standard Deviation 1.16	-0.49 Mean beta weights for ROI win > neutral Standard Deviation 1.59
Change in Brain (Striatal and Medial PFC) Activation During a Monetary Reward Gambling Task medial pfc	-0.2 Mean beta weights for ROI win > neutral Standard Deviation 0.9	-0.17 Mean beta weights for ROI win > neutral Standard Deviation 1.31

PRIMARY outcome

Timeframe: Change in reward learning from pre-treatment (baseline) to post-treatment (12 weeks).

Population: 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

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

Outcome measures

Outcome measures
Measure	Behavioral Activation n=32 Participants 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.	Non-anhedonic Adolescent Control Group n=38 Participants Non-anhedonic (healthy control) adolescents who did not receive behavioral activation
Change in Performance (Reward Learning) on the Probabilistic Reward Task (PRT) Computer Task	0.08 reward learning score Standard Deviation 0.18	0.1 reward learning score Standard Deviation 0.2

Adverse Events

Behavioral Activation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Behavioral Activation n=80 participants at risk 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.
Psychiatric disorders Suicide attempt	1.2% 1/80 • Number of events 1 • 12 week behavioral activation trial with 6-month and 1-year follow-up
Nervous system disorders Seizure	1.2% 1/80 • Number of events 1 • 12 week behavioral activation trial with 6-month and 1-year follow-up

Other adverse events

Adverse event data not reported

Additional Information

Christian Webb, PhD

McLean Hospital

Phone: 6178554429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place