Boston, Massachusetts 02115


Purpose:

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.


Study summary:

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 1. enhancing engagement through the use of video and other games, 2. enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and 3. harnessing the power of the family to enhance contextual learning and the generality and duration of effects. Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.


Criteria:

Inclusion Criteria: - Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years - Estimated IQ > 70 - Speak fluent English - Have at least one parent or adult family member who also speaks fluent English and is willing to participate Exclusion Criteria: - Physical limitations precluding effective use of biofeedback videogames - Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated. - Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician


NCT ID:

NCT02531243


Primary Contact:

Principal Investigator
Kristen Woodberry, MSW, Ph.D.
Beth Israel Deaconess Medical Center

Kristen A Woodberry, MSW, Ph.D.
Phone: 617-754-1213
Email: kwoodber@bidmc.harvard.edu


Backup Contact:

Email: cchokran@bidmc.harvard.edu
Cole M Chokran, BA
Phone: 617-754-1225


Location Contact:

Boston, Massachusetts 02115
United States

Kristen Woodberry, MSW, Ph.D.
Phone: 617-754-1213
Email: kwoodber@bidmc.harvard.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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