Computer-Aided Learning for Managing Stress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-01-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Psychosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CALMS

12 session family therapy using multi-user biofeedback games

Group Type EXPERIMENTAL

CALMS

Intervention Type BEHAVIORAL

Family Therapy; Multi-user Biofeedback Videogames

Interventions

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CALMS

Family Therapy; Multi-user Biofeedback Videogames

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No