Computer-Aided Learning for Managing Stress (CALMS)

Beth Israel Lahey Health

Status: Completed

Conditions: Psychosis

Treatments: Behavioral: CALMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02531243

2012P000377

K23MH102358 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

CALMS

Experimental group

Description:

12 session family therapy using multi-user biofeedback games

Treatment:

Behavioral: CALMS