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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01721499
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress; Obesity; Overeating	Behavioral: Nutritional Counseling; Behavioral: Mindfulness Intervention	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Development of treatment approaches [1 year]

   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. Measure effectiveness of intervention [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Rajita Sinha, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajita Sinha, Professor, Yale University
• ClinicalTrials.gov Identifier: NCT01721499
• Other Study ID Numbers: 0809004271
• First Posted: Nov 4, 2012
• Last Update Posted: Jul 30, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Rajita Sinha, Professor, Yale University: Stress; obesity; overeating
• Additional relevant MeSH terms: Hyperphagia

Study Results

No Results Posted as of Jul 30, 2015