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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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