Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
NCT Number: NCT02531243
The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.
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Notify Me12 year–30 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.
In this feasibility study, family dyads will participate in 12 sessions aimed at
Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Family Therapy; Multi-user Biofeedback Videogames
Time frame: Up to six months
Enrollment
Time frame: Up to six months
Engagement: Percent of sessions completed by consented and eligible participants
Time frame: Up to six months
Time frame: 12 week assessment or last assessment completed
Individual and family member self-report
Time frame: 12 week assessment or last assessment completed
Self-report of ability to learn/use technology to lower stress reactivity
Time frame: Weeks 4, 8, and 12 Assessments
Self-report via Perceived Stress Scale
Time frame: Weeks 4, 8, 12 Assessments
Self-report of conflict, criticism, and warmth in relationship with participating family member
Time frame: Weeks 4, 8, 12 Assessments
Self-report of conflict, criticism, and warmth in relationship with youth
Time frame: Weeks 4,8, and 12 Assessments
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Time frame: Weeks 4, 8, and 12 Assessments
Global Functioning: Social & Role Scales;
Time frame: Weeks 4, 8, and 12 Assessments
SIPS Global Assessment of Functioning
Time frame: Weeks 4, 8, and 12
Self-report
Time frame: Weeks 4, 8, and 12
Self-report
Time frame: Baseline, Weeks 4,8, and 12
Executive Control of Emotion
Beth Israel Deaconess Medical Center
Other
A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
Acronym: CALMS
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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