Clinical trial NCT04719949: Shaping Actions and Responses to Emotions
Official title: Investigating the Effects of Youth Life Experiences on Reward and Cognitive Processes in Brief Interventions for Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Adolescence
Adverse Childhood Experiences
Keywords: Depression
Adolescents
Behavioral Activation Therapy
Problem Solving Therapy
Childhood Adversity
Executive Function
Reward Processing
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2021-01-22
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Reward responsiveness immediately post-intervention
timeFrame: Immediately post-intervention
measure: Reward sensitivity immediately post-intervention
timeFrame: Immediately post-intervention
measure: Executive functioning (task-switching total incorrect)
timeFrame: Immediately post-intervention
measure: Executive functioning (task-switching reaction latency)
timeFrame: Immediately post-intervention
measure: Executive functioning (planning total)
timeFrame: Immediately post-intervention
measure: Executive functioning (planning moves)
timeFrame: Immediately post-intervention
measure: Executive functioning (planning initial thinking time)
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Change in clinician-rated depression symptoms from baseline to one-month follow-up
timeFrame: Pre-intervention vs. 1-month post-intervention
measure: Change in self-reported depression symptoms from baseline to one-month follow-up
timeFrame: Pre-intervention vs. 1-month post-intervention
Other outcomes:
measure: Reward Probability Index (RPI) up to 1-month follow-up
timeFrame: immediately post-intervention; baseline vs. 1-month post-intervention
measure: Problem Resolution Outcome Survey (PROS) up to 1-month follow-up
timeFrame: immediately post-intervention; baseline vs. 1-month follow-up
measure: Behavioral Activation for Depression Scale (BADS) up to 1-month follow-up
timeFrame: immediately post-intervention; baseline vs. 1-month post-intervention
measure: Executive functioning (task-switching congruent errors)
timeFrame: Immediately post-intervention
measure: Executive functioning (task-switching incongruent errors)
timeFrame: Immediately post-intervention
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel A Vaughn-Coaxum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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