Computer-Aided Learning for Managing Stress

Beth Israel Deaconess Medical Center25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psychosis

Interventions

CALMSBEHAVIORAL

Family Therapy; Multi-user Biofeedback Videogames

Eligibility

Sex: ALLMin age: 12 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Feasibility: Percent of referred who consent and meet study criteria

Enrollment

Time frame: Up to six months

Feasibility: Percent of 12 sessions completed

Engagement: Percent of sessions completed by consented and eligible participants

Time frame: Up to six months

Feasibility: Counts of premature termination of intervention

Time frame: Up to six months

Feasibility: Self-report of Credibility/Satisfaction

Individual and family member self-report

Time frame: 12 week assessment or last assessment completed

Feasibility: Self-report of User Experience

Self-report of ability to learn/use technology to lower stress reactivity

Time frame: 12 week assessment or last assessment completed

Secondary Outcomes

Change in Perceived Stress relative to Baseline

Self-report via Perceived Stress Scale

Time frame: Weeks 4, 8, and 12 Assessments

Change relative to Baseline in Youth Perceptions of Relationship with Family Member

Self-report of conflict, criticism, and warmth in relationship with participating family member

Time frame: Weeks 4, 8, 12 Assessments

Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult

Self-report of conflict, criticism, and warmth in relationship with youth

Data from ClinicalTrials.gov

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