Trials / Completed
CompletedNCT02531243
Computer-Aided Learning for Managing Stress
A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 12 Years – 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CALMS | Family Therapy; Multi-user Biofeedback Videogames |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-01-05
- Completion
- 2018-01-05
- First posted
- 2015-08-24
- Last updated
- 2018-02-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02531243. Inclusion in this directory is not an endorsement.