Computer-Aided Learning for Managing Stress

Study Overview
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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.

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 enhancing engagement through the use of video and other games, enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and 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.

Official Title
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A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: CALMS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALMS<br>12 session family therapy using multi-user biofeedback games | Behavioral: CALMS<br>* Family Therapy; Multi-user Biofeedback Videogames<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Percent of referred who consent and meet study criteria | Enrollment | Up to six months | 
| Feasibility: Percent of 12 sessions completed | Engagement: Percent of sessions completed by consented and eligible participants | Up to six months | 
| Feasibility: Counts of premature termination of intervention |  | Up to six months | 
| Feasibility: Self-report of Credibility/Satisfaction | Individual and family member self-report | 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 | 12 week assessment or last assessment completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress relative to Baseline | Self-report via Perceived Stress Scale | 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 | 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 | Weeks 4, 8, 12 Assessments | 
| Positive Symptom Score Change relative to Baseline | Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS) | Weeks 4,8, and 12 Assessments | 
| Change in Social and Role Functioning relative to Baseline | Global Functioning: Social & Role Scales; | Weeks 4, 8, and 12 Assessments | 
| Change in Global Functioning relative to Baseline | SIPS Global Assessment of Functioning | Weeks 4, 8, and 12 Assessments | 
| Safety: Change in Hostility/Aggression relative to Baseline | Self-report | Weeks 4, 8, and 12 | 
| Safety: Change in Video-game Addiction relative to Baseline | Self-report | Weeks 4, 8, and 12 | 
| Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task | Executive Control of Emotion | Baseline, Weeks 4,8, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prodrome, family therapy, clinical high risk