RECRUITING

Mood and Thought Process Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective for this project is to test whether affective executive functioning is a mechanism of action of mindfulness-based cognitive therapy and Wellness for Wellbeing. The main questions it aims to answer are: 1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (i.e., emotionally valenced inhibition as measured via the affective Go/No Go task) using an RCT. 2. Test the effect of MBCT vs. Wellness for Wellbeing on (a) affective updating and (b) affective shifting. Outcomes will be measured with the affective n-Back and the affective Internal Switching Task, respectively. 3a) The investigators will examine whether depression symptom severity co-varies with change in affective executive functioning (i.e., affecting inhibition, shifting, and updating) over time. 3b) The investigators will examine whether compliance with treatment protocol (e.g., number of classes attended, amount of home practice) predicts endpoint executive functioning. Participants will complete surveys, interviews, and computer tasks, and will be randomized to either Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing.

Official Title

Affective Executive Functioning As a Mechanism of Treatments for Depression Symptoms

Quick Facts

Study Start:2023-04-06
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05585775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults 18 years or older
  2. 2. English fluency in order to complete study procedures
  3. 3. Normal vision or corrected to normal vision
  4. 4. QIDS score ≥ 5 and ≤ 15 to include individuals with elevated, but not severe symptoms of depression
  5. 5. No presence of psychotic symptoms that interfere with functioning
  6. 6. No current hazardous alcohol or drug use
  7. 7. No previous experience with mindfulness-based treatment (i.e., enrollment in MBSR or MBCT previously)
  8. 8. No current symptoms of mania indicative of a manic episode
  9. 9. No current cognitive impairment
  10. 10. No history of a formally diagnosed learning disability in reading, intellectual disability or other developmental disorder
  11. 11. No history of a neurologic illness affecting cognition
  12. 12. If on psychiatric medications, no change in medications for at least 4 weeks
  13. 13. If in psychotherapy, no change in therapy status for at least 4 weeks
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Morganne Kraines, PhD
CONTACT
401-455-6626
MKraines@carene.org

Principal Investigator

Morganne Kraines, PhD
PRINCIPAL_INVESTIGATOR
Butler Hospital

Study Locations (Sites)

Butler Hospital
Providence, Rhode Island, 02906
United States

Collaborators and Investigators

Sponsor: Butler Hospital

  • Morganne Kraines, PhD, PRINCIPAL_INVESTIGATOR, Butler Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-06
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-04-06
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Depression in Remission
  • Depressive Symptoms
  • Depression