Computer-Aided Learning for Managing Stress
- Conditions
- Psychosis
- Interventions
- Behavioral: CALMS
- Registration Number
- NCT02531243
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CALMS CALMS 12 session family therapy using multi-user biofeedback games
- Primary Outcome Measures
Name Time Method Feasibility: Percent of referred who consent and meet study criteria Up to six months Enrollment
Feasibility: Percent of 12 sessions completed Up to six months Engagement: Percent of sessions completed by consented and eligible participants
Feasibility: Counts of premature termination of intervention Up to six months Feasibility: Self-report of Credibility/Satisfaction 12 week assessment or last assessment completed Individual and family member self-report
Feasibility: Self-report of User Experience 12 week assessment or last assessment completed Self-report of ability to learn/use technology to lower stress reactivity
- Secondary Outcome Measures
Name Time Method Safety: Change in Hostility/Aggression relative to Baseline Weeks 4, 8, and 12 Self-report
Change in Perceived Stress relative to Baseline Weeks 4, 8, and 12 Assessments Self-report via Perceived Stress Scale
Change relative to Baseline in Youth Perceptions of Relationship with Family Member Weeks 4, 8, 12 Assessments Self-report of conflict, criticism, and warmth in relationship with participating family member
Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult Weeks 4, 8, 12 Assessments Self-report of conflict, criticism, and warmth in relationship with youth
Positive Symptom Score Change relative to Baseline Weeks 4,8, and 12 Assessments Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Change in Social and Role Functioning relative to Baseline Weeks 4, 8, and 12 Assessments Global Functioning: Social \& Role Scales;
Change in Global Functioning relative to Baseline Weeks 4, 8, and 12 Assessments SIPS Global Assessment of Functioning
Safety: Change in Video-game Addiction relative to Baseline Weeks 4, 8, and 12 Self-report
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task Baseline, Weeks 4,8, and 12 Executive Control of Emotion
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States