Computer-Aided Learning for Managing Stress

Psychosis Clinical Trial

— CALMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531243
• Other study ID #: 2012P000377
• Secondary ID: K23MH102358
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: February 22, 2018
• Start date: September 2015
• Est. completion date: January 5, 2018

Study information

• Verified date: February 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychosis

Intervention

Behavioral:
• CALMS
Family Therapy; Multi-user Biofeedback Videogames

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Boston Children’s Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Percent of referred who consent and meet study criteria	Enrollment	Up to six months
Primary	Feasibility: Percent of 12 sessions completed	Engagement: Percent of sessions completed by consented and eligible participants	Up to six months
Primary	Feasibility: Counts of premature termination of intervention		Up to six months
Primary	Feasibility: Self-report of Credibility/Satisfaction	Individual and family member self-report	12 week assessment or last assessment completed
Primary	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	Change in Perceived Stress relative to Baseline	Self-report via Perceived Stress Scale	Weeks 4, 8, and 12 Assessments
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Social and Role Functioning relative to Baseline	Global Functioning: Social & Role Scales;	Weeks 4, 8, and 12 Assessments
Secondary	Change in Global Functioning relative to Baseline	SIPS Global Assessment of Functioning	Weeks 4, 8, and 12 Assessments
Secondary	Safety: Change in Hostility/Aggression relative to Baseline	Self-report	Weeks 4, 8, and 12
Secondary	Safety: Change in Video-game Addiction relative to Baseline	Self-report	Weeks 4, 8, and 12
Secondary	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