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

Primary Purpose

Stress, Obesity, Overeating

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nutritional Counseling
Mindfulness Intervention
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Stress, obesity, overeating

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness intervention

Nutrition Control Group

Arm Description

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.

The control group receives 6 nutritional counseling sessions.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2012
Last Updated
July 28, 2015
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01721499
Brief Title
Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training
Acronym
Sync
Official Title
Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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. Develop and implement "Stress in Control" (SynC) training competence and adherence rating scales; 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. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Obesity, Overeating
Keywords
Stress, obesity, overeating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Control Group
Arm Type
Active Comparator
Arm Description
The control group receives 6 nutritional counseling sessions.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention Description
weekly group and individual skills training to improve self control and decrease stress.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Primary Outcome Measure Information:
Title
Development of treatment approaches
Description
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.
Time Frame
1 year
Title
Measure effectiveness of intervention
Description
Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between ages 18-60 years; Able to read and write; Interested in treatment aimed at gaining greater control over an unhealthy, maladaptive behavior Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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