Shaping Actions and Responses to Emotions

NCT04719949 | Completed DMC

• 1 other identifier: STUDY20040184
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Adolescence; Adverse Childhood Experiences

Keywords

Depression; Adolescents; Behavioral Activation Therapy; Problem Solving Therapy; Childhood Adversity; Executive Function; Reward Processing

Outcome Measures

Primary Outcomes (7)

• 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.

  Immediately post-intervention

• 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.

  Immediately post-intervention

• 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).

  Immediately post-intervention

• 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).

  Immediately post-intervention

• 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).

  Immediately post-intervention

• 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).

  Immediately post-intervention

• 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).

  Immediately post-intervention

Secondary Outcomes (2)

• Change in clinician-rated depression symptoms from baseline to one-month follow-up

  Pre-intervention vs. 1-month post-intervention

• Change in self-reported depression symptoms from baseline to one-month follow-up

  Pre-intervention vs. 1-month post-intervention

Other Outcomes (5)

• Reward Probability Index (RPI) up to 1-month follow-up

  immediately post-intervention; baseline vs. 1-month post-intervention

• Problem Resolution Outcome Survey (PROS) up to 1-month follow-up

  immediately post-intervention; baseline vs. 1-month follow-up

• Behavioral Activation for Depression Scale (BADS) up to 1-month follow-up

  immediately post-intervention; baseline vs. 1-month post-intervention

Study Arms (2)

Behavioral Activation (BA) Therapy

EXPERIMENTAL

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

Behavioral: Behavioral Activation (BA) Therapy

Problem Solving Therapy (PST)

ACTIVE COMPARATOR

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

Behavioral: Problem Solving Therapy (PST)

Interventions

Behavioral Activation (BA) Therapy BEHAVIORAL

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.

Behavioral Activation (BA) Therapy

Problem Solving Therapy (PST) BEHAVIORAL

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.

Problem Solving Therapy (PST)

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Klingenstein Third Generation Foundation: collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 28756787 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rachel A Vaughn-Coaxum, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: February 9, 2021
• Primary Completion: August 17, 2023
• Study Completion: September 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Open to anyone who wishes to access the data.

Locations

US (1)