- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01721499
Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training (Sync)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06519
- Yale University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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. |
weekly group and individual skills training to improve self control and decrease stress.
|
Aktiver Komparator: Nutrition Control Group
The control group receives 6 nutritional counseling sessions.
|
weekly group and individual skills training to improve self control and decrease stress.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Development of treatment approaches
Zeitfenster: 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.
|
1 year
|
Measure effectiveness of intervention
Zeitfenster: 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
|
2 years
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0809004271
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Nutritional Counseling
-
US Department of Veterans AffairsAbgeschlossenDrogenmissbrauch | Doppelte DiagnoseVereinigte Staaten
-
Temple UniversityUnbekanntSitzende Lebensweise | Zigaretten rauchenVereinigte Staaten
-
Fonterra Research CentreSprim Advanced Life SciencesAbgeschlossen
-
Hacettepe UniversityAbgeschlossenTyp 2 DiabetesTruthahn
-
Rabin Medical CenterNG Solutions LtdAktiv, nicht rekrutierend
-
Fatih Sultan Mehmet Training and Research HospitalAktiv, nicht rekrutierendCOVID-19 | Lifestyle-FaktorenTruthahn
-
Texas Christian UniversityAktiv, nicht rekrutierendMapping-Ansätze zur Vorbereitung des Implementierungstransfers | Behandlungsbereitschaft und EinführungsprogrammVereinigte Staaten
-
Makerere UniversityMinistry of Health, Uganda; Rakai Health Sciences ProjectAktiv, nicht rekrutierend
-
University of California, San DiegoKenya Ministry of Health; Population Council KenyaRekrutierungGewalt in der Partnerschaft | Reproduktiver ZwangKenia
-
Duke UniversityAbgeschlossenBehandlung und Vorbeugung von Anämie nach Verabreichung von Gudness Nutrition BarIndien