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Completed

NCT Number: NCT02531243

Computer-Aided Learning for Managing Stress

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.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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

  • enhancing engagement through the use of video and other games,
  • enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CALMS

Behavioral

Family Therapy; Multi-user Biofeedback Videogames

Primary outcomes

  1. Feasibility: Percent of referred who consent and meet study criteria

    Time frame: Up to six months

    Enrollment

  2. Feasibility: Percent of 12 sessions completed

    Time frame: Up to six months

    Engagement: Percent of sessions completed by consented and eligible participants

  3. Feasibility: Counts of premature termination of intervention

    Time frame: Up to six months

  4. Feasibility: Self-report of Credibility/Satisfaction

    Time frame: 12 week assessment or last assessment completed

    Individual and family member self-report

  5. Feasibility: Self-report of User Experience

    Time frame: 12 week assessment or last assessment completed

    Self-report of ability to learn/use technology to lower stress reactivity

Secondary outcomes

  1. Change in Perceived Stress relative to Baseline

    Time frame: Weeks 4, 8, and 12 Assessments

    Self-report via Perceived Stress Scale

  2. Change relative to Baseline in Youth Perceptions of Relationship with Family Member

    Time frame: Weeks 4, 8, 12 Assessments

    Self-report of conflict, criticism, and warmth in relationship with participating family member

  3. Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult

    Time frame: Weeks 4, 8, 12 Assessments

    Self-report of conflict, criticism, and warmth in relationship with youth

  4. Positive Symptom Score Change relative to Baseline

    Time frame: Weeks 4,8, and 12 Assessments

    Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)

  5. Change in Social and Role Functioning relative to Baseline

    Time frame: Weeks 4, 8, and 12 Assessments

    Global Functioning: Social & Role Scales;

  6. Change in Global Functioning relative to Baseline

    Time frame: Weeks 4, 8, and 12 Assessments

    SIPS Global Assessment of Functioning

  7. Safety: Change in Hostility/Aggression relative to Baseline

    Time frame: Weeks 4, 8, and 12

    Self-report

  8. Safety: Change in Video-game Addiction relative to Baseline

    Time frame: Weeks 4, 8, and 12

    Self-report

  9. Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task

    Time frame: Baseline, Weeks 4,8, and 12

    Executive Control of Emotion

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Boston Children's Hospital
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CALMS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2015
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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