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

Primary Purpose

Anhedonia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Activation

About this trial

This is an interventional treatment trial for Anhedonia

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

A. 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

B. 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

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Activation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in anhedonic (SHAPS) symptoms

Change in brain (striatal and medial PFC) activation during a monetary reward gambling task

Change in performance (reward learning) on a probabilistic reward learning computer task

Secondary Outcome Measures

Full Information

NCT ID

NCT02498925

First Posted

July 10, 2015

Last Updated

January 19, 2023

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02498925

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2015 (Actual)

Primary Completion Date

April 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anhedonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavioral Activation

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Activation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in anhedonic (SHAPS) symptoms

Time Frame

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

Title

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)

Title

Change in performance (reward learning) on a probabilistic reward learning computer task

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 A. 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 B. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian A Webb, Ph.D.

Organizational Affiliation

McLean Hospital & McLean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

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

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