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Regulation of Affect and Physiology in Depression

Ambulatory Phenotyping With Real-Time Indices of Discordant Affect Regulation: Exploring Opportunities for Targeted Intervention in Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 27 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for types of depression based on how people manage feelings and how their bodies respond. It is for adults ages 18–27 whose major depression has cleared up, and healthy volunteers. It also tests 10 days of home biofeedback, which uses signals from the body to help people learn to control body responses.

Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Everyone must be age 18–27.
  • Depression group: You must have had major depression in the past.
  • Depression group: You must have had no major depression symptoms for at least 8 weeks and score 7 or lower on the Hamilton depression rating scale.
  • Healthy volunteer group: You must never have had a mental health disorder.
  • Healthy volunteer group: No parent, sibling, or child may have a mood disorder, such as depression.

Who can't join

  • A change in use of mental health medicines in the past 30 days.
  • Autism spectrum disorder.
  • A current eating disorder.
  • An intellectual disability, which affects learning and daily living skills.
  • A substance use disorder, or problem use of alcohol or drugs, in the past 6 months.
  • A reason you cannot safely have an MRI scan or ECG heart test, such as metal in your body, fear of tight spaces, a heart device, or pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for Participants with Remitted Depression: 1. Age 18-27. 2. Meeting criteria for lifetime major depressive disorder. 3. Currently meeting criteria for full remission (absence of clinically significant symptoms) for at least eight weeks, and having a Hamilton Depression Rating Scale score of less than or equal to 7. Inclusion Criteria for Healthy Volunteer Participants: 1. Age 18-27. 2. No lifetime history of any psychiatric disorder. 3. No first-degree relatives with a mood disorder. Exclusion Criteria (same for all participants): 1. Change in psychotropic medication use within the last 30 days 2. Autism spectrum disorder 3. Current eating disorder 4. Intellectual disability 5. Substance use disorder within the past 6 months 6. Contraindications for magnetic resonance imaging or electrocardiogram assessment (e.g., presence of metal in body, claustrophobia, cardiac device, pregnancy).

Study sites (1)

CA