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Completed

NCT Number: NCT01721499

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional counseling

Behavioral

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

Mindfulness Intervention

Behavioral

Primary outcomes

  1. Development of treatment approaches

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: Sync

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 5, 2012
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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