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Shaping Actions and Responses to Emotions (ShARE)

Primary Purpose

Depression in Adolescence, Adverse Childhood Experiences

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation (BA) Therapy
Problem Solving Therapy (PST)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression in Adolescence focused on measuring Depression, Adolescents, Behavioral Activation Therapy, Problem Solving Therapy, Childhood Adversity, Executive Function, Reward Processing

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elevated depressive symptoms (PHQ-9 ≥ 7, confirmed by clinician rating on the Depression Rating scale)
  • IQ (Intelligence Quotient) ≥ 70

Exclusion Criteria:

  • Intellectual Disability, Pervasive Developmental Delay, or Autism Spectrum Disorders
  • Bipolar Disorder
  • Substance dependence or abuse
  • History of psychosis
  • Medical illness affecting measurement of cognitive and behavioral processes

Sites / Locations

  • Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation (BA) Therapy

Problem Solving Therapy (PST)

Arm Description

Participants complete four sessions of BA, 60-90 minutes per session.

Participants complete four sessions of PST, 60-90 minutes per session.

Outcomes

Primary Outcome Measures

Reward responsiveness immediately post-intervention
This primary outcome measure, a response reversal task, is a computerized behavioral task assessing reward processing probabilistically. The task presents adolescents with pairs of pictures on the screen and instructs them to choose one. They receive feedback that their choice is correct or incorrect, and one pictures if positively reinforced 80% of the time. The probabilities change during the task, such that the picture that was rewarded as correct 80% of the time changes to be incorrect 80% of the time. Indices of this task estimate adolescents' responsiveness to changing reward probabilities based on how quickly (learning rate) they learn the change in contingencies.
Reward sensitivity immediately post-intervention
This primary outcome measure, the Balloon Analogue Risk Task, is a computerized behavioral task assessing reward sensitivity. The task allows adolescents a choice regarding the amount of effort they want to exert to obtain a reward (points/cash) in a game where they must titrate their effort to maximize the likelihood of obtaining a reward. The primary index is the average amount of effort (pumps on a balloon) on trials where a reward is earned.
Executive functioning (task-switching total incorrect)
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the total number of trials with incorrect responses as a primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=0-160).
Executive functioning (task-switching reaction latency)
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the median latency to response (reaction time) as primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=100-2000).
Executive functioning (planning total)
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The number of problems that the participants complete with the minimum number of moves is a primary index. Better scores indicate more efficient planning, better scores at post-intervention than pre-intervention indicate improvement (score range=0-12).
Executive functioning (planning moves)
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The mean number of moves that a participant requires to complete the problems is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (score range=5-12).
Executive functioning (planning initial thinking time)
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The difference in the time taken to select the first move in the "problem solve" vs. "follow" conditions is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (minimum score = 0, maximum score = N/A).

Secondary Outcome Measures

Change in clinician-rated depression symptoms from baseline to one-month follow-up
The clinician-rated Depression Rating Scale (DRS) from the Kiddie Schedule for Affective Disorders and Schizophrenia assesses depression symptom severity and will be used to evaluate symptom severity on a continuous scale from 0-61, where higher scores indicate more severe symptoms across the primary symptom domains of Major Depression.
Change in self-reported depression symptoms from baseline to one-month follow-up
The Mood and Feelings Questionnaire (MFQ) is a self-report questionnaire assessing youth depression symptoms in the last two weeks. Items are presented on a 3-point scale with ratings of 0=Not True, 1=Sometimes, and 2=True. A total sum score (range=0-66) is generated with higher scores indicating more severe symptoms. Reliability and validity of the scale has been well-established in existing psychometric research.

Full Information

First Posted
January 18, 2021
Last Updated
October 7, 2023
Sponsor
University of Pittsburgh
Collaborators
The Klingenstein Third Generation Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04719949
Brief Title
Shaping Actions and Responses to Emotions
Acronym
ShARE
Official Title
Investigating the Effects of Youth Life Experiences on Reward and Cognitive Processes in Brief Interventions for Adolescent Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Klingenstein Third Generation Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this research is to examine two brief interventions for depression, Behavioral Activation (BA), and Problem Solving Therapy (PST), to investigate whether exposure to adverse childhood experiences influences change in the hypothesized target treatment mechanisms linked to each intervention. Research suggests that the treatment targets of BA (reward processing) may be well-matched for youths exposed to childhood adversity, due to disruptions in reward that are linked with adversity exposure. The investigators will examine the effects of youths' adverse life experiences on change in reward-related treatment targets in BA, and compare this to change in the treatment targets of PST, executive functioning processes. The first aim is to investigate the effects of childhood adversity on change in target treatment mechanisms in BA and PST. The second aim is to test whether changes in reward processes is specific to BA, and not PST, among youths exposed to adversity. The third aim is to test the match of BA for depression among youths exposed to adversity, by examining whether BA results in greater reductions in depression symptoms among youths with greater adversity exposure. The investigators will also test whether greater change in reward in associated with greater depression symptom reductions in BA, and not PST.
Detailed Description
ASSESSMENT: Adolescents and a parent that is able to provide consent for participation will be contacted by research staff to discuss the research project and determine interest in study participation. With verbal permission from the parent, both the parent and adolescent will complete an eligibility screener over the phone. The eligibility screener includes demographic information, psychiatric history, and current depression symptoms (adolescent-report Patient Health Questionnaire-9 and the parent-report Children's Depression Inventory-2) to confirm that interested families meet initial inclusion criteria. Baseline Assessment. A baseline assessment will be scheduled with all families. Informed consent and assent will be obtained prior to the start of any baseline assessment activities. A diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia: K-SADS-P/L) will be completed by a trained study staff member with each adolescent and their consenting parent. Diagnoses will be based on consensus ratings between adolescents and parents. Study staff will also administer the pediatric Columbia Suicide Severity Rating Scale, the Depression Rating Scale (embedded in K-SADS-P/L), and the Stress and Adversity Inventory (STRAIN). Participants and parent will complete self-report questionnaires assessing depression symptom severity, sleep behavior, family and participant demographics, pubertal development, behavioral activation, and problem solving strategies and efficacy. The Wechsler Abbreviated Scale for Intelligence-II (WASI-II), the Cambridge Neuropsychological Test Automated Battery (CANTAB), and reward processing outcome tasks will be administered to the adolescent by study staff in the lab setting. Final study eligibility will be confirmed based on interviews and the WASI-II. RANDOMIZATION: The investigators will use a simple randomization procedure whereby 50% of participants will be randomly assigned to Behavioral Activation (BA) and 50% to Problem Solving Therapy (PST). INTERVENTIONS: Behavioral Activation (BA) Therapy. Brief BA is a manualized individual psychotherapy adapted to a four-session structure for this pilot study. The first session provides psychoeducation about the value and reinforcement of various behaviors and treatment rationale. Three additional sessions include reviewing the youth's log of the activities they planned each week, assessing youths' values and planning further valued activities, and reviewing progress. Problem Solving Therapy (PST). Brief PST is a manualized individual psychotherapy adapted to a four-session structure for this study. The first session provides psychoeducation on links between mood and managing social problems, as well as defining and identifying individual problems. Three additional sessions focus on generating solutions, decision making, implementing solutions, and evaluation and assessment of the outcomes of these solutions. Adherence. A randomly selected 10% of the audio recorded sessions from each intervention will be reviewed and coded for therapist adherence to each protocol. Graduate and undergraduate student raters will be trained code sessions reliably, and the PI will conduct quarterly data checks to ensure coders remain reliable. ENGAGEMENT OF TARGET TREATMENT MECHANISMS. Following the last therapy session, participants will repeat the four computerized behavioral tasks that were administered at baseline. Change in scores from pre- to post-intervention reflects change in the target treatment mechanisms. Youths will complete depression rating scales online at post-treatment, and again at one-month follow-up to assess the effects of the intervention on depression symptom levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Adolescence, Adverse Childhood Experiences
Keywords
Depression, Adolescents, Behavioral Activation Therapy, Problem Solving Therapy, Childhood Adversity, Executive Function, Reward Processing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation (BA) Therapy
Arm Type
Experimental
Arm Description
Participants complete four sessions of BA, 60-90 minutes per session.
Arm Title
Problem Solving Therapy (PST)
Arm Type
Active Comparator
Arm Description
Participants complete four sessions of PST, 60-90 minutes per session.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation (BA) Therapy
Intervention Description
Brief BA is a manualized individual psychotherapy adapted to a four-session structure for this pilot study. The first session provides psychoeducation about the value and reinforcement of various behaviors and treatment rationale. Three additional sessions include reviewing the youth's log of the activities they planned each week, assessing youths' values and planning further valued activities, and reviewing progress.
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving Therapy (PST)
Intervention Description
Brief PST is a manualized individual psychotherapy adapted to a four-session structure for this study. The first session provides psychoeducation on links between mood and managing social problems, as well as defining and identifying individual problems. Three additional sessions focus on generating solutions, decision making, implementing solutions, and evaluation and assessment of the outcomes of these solutions.
Primary Outcome Measure Information:
Title
Reward responsiveness immediately post-intervention
Description
This primary outcome measure, a response reversal task, is a computerized behavioral task assessing reward processing probabilistically. The task presents adolescents with pairs of pictures on the screen and instructs them to choose one. They receive feedback that their choice is correct or incorrect, and one pictures if positively reinforced 80% of the time. The probabilities change during the task, such that the picture that was rewarded as correct 80% of the time changes to be incorrect 80% of the time. Indices of this task estimate adolescents' responsiveness to changing reward probabilities based on how quickly (learning rate) they learn the change in contingencies.
Time Frame
Immediately post-intervention
Title
Reward sensitivity immediately post-intervention
Description
This primary outcome measure, the Balloon Analogue Risk Task, is a computerized behavioral task assessing reward sensitivity. The task allows adolescents a choice regarding the amount of effort they want to exert to obtain a reward (points/cash) in a game where they must titrate their effort to maximize the likelihood of obtaining a reward. The primary index is the average amount of effort (pumps on a balloon) on trials where a reward is earned.
Time Frame
Immediately post-intervention
Title
Executive functioning (task-switching total incorrect)
Description
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the total number of trials with incorrect responses as a primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=0-160).
Time Frame
Immediately post-intervention
Title
Executive functioning (task-switching reaction latency)
Description
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the median latency to response (reaction time) as primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=100-2000).
Time Frame
Immediately post-intervention
Title
Executive functioning (planning total)
Description
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The number of problems that the participants complete with the minimum number of moves is a primary index. Better scores indicate more efficient planning, better scores at post-intervention than pre-intervention indicate improvement (score range=0-12).
Time Frame
Immediately post-intervention
Title
Executive functioning (planning moves)
Description
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The mean number of moves that a participant requires to complete the problems is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (score range=5-12).
Time Frame
Immediately post-intervention
Title
Executive functioning (planning initial thinking time)
Description
This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The difference in the time taken to select the first move in the "problem solve" vs. "follow" conditions is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (minimum score = 0, maximum score = N/A).
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Change in clinician-rated depression symptoms from baseline to one-month follow-up
Description
The clinician-rated Depression Rating Scale (DRS) from the Kiddie Schedule for Affective Disorders and Schizophrenia assesses depression symptom severity and will be used to evaluate symptom severity on a continuous scale from 0-61, where higher scores indicate more severe symptoms across the primary symptom domains of Major Depression.
Time Frame
Pre-intervention vs. 1-month post-intervention
Title
Change in self-reported depression symptoms from baseline to one-month follow-up
Description
The Mood and Feelings Questionnaire (MFQ) is a self-report questionnaire assessing youth depression symptoms in the last two weeks. Items are presented on a 3-point scale with ratings of 0=Not True, 1=Sometimes, and 2=True. A total sum score (range=0-66) is generated with higher scores indicating more severe symptoms. Reliability and validity of the scale has been well-established in existing psychometric research.
Time Frame
Pre-intervention vs. 1-month post-intervention
Other Pre-specified Outcome Measures:
Title
Reward Probability Index (RPI) up to 1-month follow-up
Description
The RPI is a self-report measure assessing access to rewards in one's environment, including reward probability and suppression of rewards in the environment. Items are presented on a 4-point scale from 1=strong disagree to 4=strongly agree. Ratings of access to rewards are within the preceding one month period.
Time Frame
immediately post-intervention; baseline vs. 1-month post-intervention
Title
Problem Resolution Outcome Survey (PROS) up to 1-month follow-up
Description
The PROS is a self-report measure assessing multiple components of problem solving: problem-solving strategies, problem-solving efficacy. There is also a sub-scale assessing general satisfaction with therapy for administration of the PROS post-intervention. Items are presented on a 6-point scale from 1=strongly agree to 6=strongly disagree.
Time Frame
immediately post-intervention; baseline vs. 1-month follow-up
Title
Behavioral Activation for Depression Scale (BADS) up to 1-month follow-up
Description
The BADS is a self-report measure assessing different behavioral aspects of depression including activation, rumination or avoidance, and functional impairment. The BADS was developed to assess change in these domains over the course of treatment. Items are presented on a 6-point from scale, where 0=not at all, 2=a little, 4=a lot, and 6=completely. The validity and reliability research on this measure indicates that the total score is the most reliable and robust index.
Time Frame
immediately post-intervention; baseline vs. 1-month post-intervention
Title
Executive functioning (task-switching congruent errors)
Description
This outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the number of congruent trials with an incorrect response as a primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=0-80).
Time Frame
Immediately post-intervention
Title
Executive functioning (task-switching incongruent errors)
Description
This outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the number of incongruent trials with an incorrect response as a primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=0-80).
Time Frame
Immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elevated depressive symptoms (PHQ-9 ≥ 7, confirmed by clinician rating on the Depression Rating scale) IQ (Intelligence Quotient) ≥ 70 Exclusion Criteria: Intellectual Disability, Pervasive Developmental Delay, or Autism Spectrum Disorders Bipolar Disorder Substance dependence or abuse History of psychosis Medical illness affecting measurement of cognitive and behavioral processes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel A Vaughn-Coaxum, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All participant data collected during this trial will be shared after deidentification.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Open to anyone who wishes to access the data.
Citations:
PubMed Identifier
28756787
Citation
Pass L, Lejuez CW, Reynolds S. Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study. Behav Cogn Psychother. 2018 Mar;46(2):182-194. doi: 10.1017/S1352465817000443. Epub 2017 Jul 31.
Results Reference
background
Citation
Eskin M, Ertekin K, Demir H. Efficacy of a problem-solving therapy for depression and suicide potential in adolescents and young adults. Cognit Ther Res. 2008;32(2):227-245. doi:10.1007/s10608-007-9172-8
Results Reference
background

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Shaping Actions and Responses to Emotions

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