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

This study is currently recruiting participants.
Verified November 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Rajita Sinha, Yale University
ClinicalTrials.gov Identifier:
NCT01721499
First received: March 8, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Stress
Obesity
Overeating
 Behavioral: Nutritional Counseling
Behavioral: Mindfulness Intervention
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Development of treatment approaches [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Measure effectiveness of intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness intervention

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
weekly group and individual skills training to improve self control and decrease stress.
Behavioral: Mindfulness Intervention
Active Comparator: Nutrition Control Group
The control group receives 6 nutritional counseling sessions.
 Behavioral: Nutritional Counseling
weekly group and individual skills training to improve self control and decrease stress.

Detailed Description:

This study proposes to pilot a mindfulness based affect-regulation treatment approach to improve self-control and physiological and biochemical indicators of stress, as well as decrease unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. The broad aims of the treatment approach will be to teach participants to (1) observe and increase awareness of cognitive, affective, bodily sensations/expressions and action-urge components of emotional/compulsion experiences; and (2) develop alternate affective, behavioral and cognitive coping strategies in managing and regulating affect/urge experiences. It is hoped that the findings from this study will aid in the further development of treatment and prevention programs targeting stress reduction and coping to improve control over maladaptive behaviors and decrease physical and mental health symptoms.

Aims:

  1. 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.
  2. Develop and implement "Stress in Control" (SynC) training competence and adherence rating scales;
  3. Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment Control Group and a Historical Control Group approach for 100 individuals interested in help in decreasing targeted unhealthy behaviors. Primary outcomes will be a reduction in unhealthy problem behaviors, and secondary outcomes will be decrease in measures of stress, and increases in emotion regulation and self control.
  4. (secondary aim) Collect baseline data on measures of self control, mood, coping, personality, cognitive functioning, acute and chronic stress, and mental and physical health on a large sample of subjects seeking help in decreasing unhealthy behaviors.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
  2. Pregnant women will be excluded.
  3. Inability to give informed consent
  4. Traumatic brain injury or loss of consciousness
  5. Medical problems requiring immediate attention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721499

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Keri L Tuit, PsyD     203-737-1176     keri.tuit@yale.edu    
Principal Investigator: Rajita Sinha, PhD            
Principal Investigator: Keri L Tuit, PsyD            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University
  More Information

No publications provided

Responsible Party: Rajita Sinha, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01721499     History of Changes
Other Study ID Numbers: 0809004271
Study First Received: March 8, 2012
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Stress
obesity
overeating

Additional relevant MeSH terms:
Hyperphagia
Obesity
Signs and Symptoms, Digestive
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight
Body Weight

ClinicalTrials.gov processed this record on May 21, 2013