Computer-Aided Learning for Managing Stress (CALMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: CALMS

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute of Mental Health (NIMH); Boston Children's Hospital
• Investigators: Principal Investigator: Kristen Woodberry, MSW, Ph.D., Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Woodberry KA, Chokran C, Johnson KA, Nuechterlein KH, Miklowitz DJ, Faraone SV, Seidman LJ. Computer-aided learning for managing stress: A feasibility trial with clinical high risk adolescents and young adults. Early Interv Psychiatry. 2021 Jun;15(3):471-479. doi: 10.1111/eip.12958. Epub 2020 Apr 1.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: family therapy; prodrome; clinical high risk
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 2012P000377; K23MH102358 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO