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

NCT ID: NCT01721499

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

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:

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.

Conditions

Stress; Obesity; Overeating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutritional Counseling

Intervention Type: BEHAVIORAL

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

Mindfulness Intervention

Intervention Type: BEHAVIORAL

Nutrition Control Group

The control group receives 6 nutritional counseling sessions.

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

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

Interventions

Nutritional Counseling

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

Intervention Type: BEHAVIORAL

Mindfulness Intervention

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Rajita Sinha

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajita Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0809004271

Identifier Type: -

Identifier Source: org_study_id