Clinical trial NCT02531243: Computer-Aided Learning for Managing Stress
Official title: A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: prodrome
family therapy
clinical high risk
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Boston Children's Hospital
First posted: 2015-08-24
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Percent of referred who consent and meet study criteria
timeFrame: Up to six months
measure: Feasibility: Percent of 12 sessions completed
timeFrame: Up to six months
measure: Feasibility: Counts of premature termination of intervention
timeFrame: Up to six months
measure: Feasibility: Self-report of Credibility/Satisfaction
timeFrame: 12 week assessment or last assessment completed
measure: Feasibility: Self-report of User Experience
timeFrame: 12 week assessment or last assessment completed
Secondary outcomes:
measure: Change in Perceived Stress relative to Baseline
timeFrame: Weeks 4, 8, and 12 Assessments
measure: Change relative to Baseline in Youth Perceptions of Relationship with Family Member
timeFrame: Weeks 4, 8, 12 Assessments
measure: Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
timeFrame: Weeks 4, 8, 12 Assessments
measure: Positive Symptom Score Change relative to Baseline
timeFrame: Weeks 4,8, and 12 Assessments
measure: Change in Social and Role Functioning relative to Baseline
timeFrame: Weeks 4, 8, and 12 Assessments
measure: Change in Global Functioning relative to Baseline
timeFrame: Weeks 4, 8, and 12 Assessments
measure: Safety: Change in Hostility/Aggression relative to Baseline
timeFrame: Weeks 4, 8, and 12
measure: Safety: Change in Video-game Addiction relative to Baseline
timeFrame: Weeks 4, 8, and 12
measure: Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
timeFrame: Baseline, Weeks 4,8, and 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Kristen Woodberry, MSW, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.