Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training

NCT01721499 | Completed Phase 1

• 1 other identifier: 0809004271
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of treatment approaches aimed to improve self-control and decrease stress and unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. High levels of stress may make it harder to maintain self-control, especially when trying to control our unhealthy behaviors. Training on improving self control and decreasing stress may help decrease unhealthy behaviors. The goal of this new training program will be to decrease a subject's unhealthy behavior by helping them better manage their stress and improve their self control over unhealthy habits.

Conditions

Stress; Obesity; Overeating

Keywords

Stress; obesity; overeating

Outcome Measures

Primary Outcomes (2)

• Development of treatment approaches

  Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.

  1 year

• Measure effectiveness of intervention

  Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment

  2 years

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL

The mindfulness intervention consists of weekly group format mindfulness instruction and skills development, weekly individual therapy sessions, and 6 nutritional sessions. The control group receives 6 nutritional sessions only.

Behavioral: Nutritional Counseling; Behavioral: Mindfulness Intervention

Nutrition Control Group

ACTIVE COMPARATOR

The control group receives 6 nutritional counseling sessions.

Behavioral: Nutritional Counseling

Interventions

Nutritional Counseling BEHAVIORAL

weekly group and individual skills training to improve self control and decrease stress.

Mindfulness intervention; Nutrition Control Group

Mindfulness Intervention BEHAVIORAL

Mindfulness intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between ages 18-60 years;
• Able to read and write;
• Interested in treatment aimed at gaining greater control over an unhealthy, maladaptive behavior

You may not qualify if:

• Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
• Pregnant women will be excluded.
• Inability to give informed consent
• Traumatic brain injury or loss of consciousness
• Medical problems requiring immediate attention

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Obesity; Hyperphagia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rajita Sinha, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: November 5, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

US (1)