Computer-Aided Learning for Managing Stress (CALMS)
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CALMS
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring prodrome, family therapy, clinical high risk
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CALMS
Arm Description
12 session family therapy using multi-user biofeedback games
Outcomes
Primary Outcome Measures
Feasibility: Percent of referred who consent and meet study criteria
Enrollment
Feasibility: Percent of 12 sessions completed
Engagement: Percent of sessions completed by consented and eligible participants
Feasibility: Counts of premature termination of intervention
Feasibility: Self-report of Credibility/Satisfaction
Individual and family member self-report
Feasibility: Self-report of User Experience
Self-report of ability to learn/use technology to lower stress reactivity
Secondary Outcome Measures
Change in Perceived Stress relative to Baseline
Self-report via Perceived Stress Scale
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
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
Positive Symptom Score Change relative to Baseline
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Change in Social and Role Functioning relative to Baseline
Global Functioning: Social & Role Scales;
Change in Global Functioning relative to Baseline
SIPS Global Assessment of Functioning
Safety: Change in Hostility/Aggression relative to Baseline
Self-report
Safety: Change in Video-game Addiction relative to Baseline
Self-report
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
Executive Control of Emotion
Full Information
NCT ID
NCT02531243
First Posted
July 13, 2015
Last Updated
February 22, 2018
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH), Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02531243
Brief Title
Computer-Aided Learning for Managing Stress
Acronym
CALMS
Official Title
A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
January 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH), Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
prodrome, family therapy, clinical high risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CALMS
Arm Type
Experimental
Arm Description
12 session family therapy using multi-user biofeedback games
Intervention Type
Behavioral
Intervention Name(s)
CALMS
Intervention Description
Family Therapy; Multi-user Biofeedback Videogames
Primary Outcome Measure Information:
Title
Feasibility: Percent of referred who consent and meet study criteria
Description
Enrollment
Time Frame
Up to six months
Title
Feasibility: Percent of 12 sessions completed
Description
Engagement: Percent of sessions completed by consented and eligible participants
Time Frame
Up to six months
Title
Feasibility: Counts of premature termination of intervention
Time Frame
Up to six months
Title
Feasibility: Self-report of Credibility/Satisfaction
Description
Individual and family member self-report
Time Frame
12 week assessment or last assessment completed
Title
Feasibility: Self-report of User Experience
Description
Self-report of ability to learn/use technology to lower stress reactivity
Time Frame
12 week assessment or last assessment completed
Secondary Outcome Measure Information:
Title
Change in Perceived Stress relative to Baseline
Description
Self-report via Perceived Stress Scale
Time Frame
Weeks 4, 8, and 12 Assessments
Title
Change relative to Baseline in Youth Perceptions of Relationship with Family Member
Description
Self-report of conflict, criticism, and warmth in relationship with participating family member
Time Frame
Weeks 4, 8, 12 Assessments
Title
Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
Description
Self-report of conflict, criticism, and warmth in relationship with youth
Time Frame
Weeks 4, 8, 12 Assessments
Title
Positive Symptom Score Change relative to Baseline
Description
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Time Frame
Weeks 4,8, and 12 Assessments
Title
Change in Social and Role Functioning relative to Baseline
Description
Global Functioning: Social & Role Scales;
Time Frame
Weeks 4, 8, and 12 Assessments
Title
Change in Global Functioning relative to Baseline
Description
SIPS Global Assessment of Functioning
Time Frame
Weeks 4, 8, and 12 Assessments
Title
Safety: Change in Hostility/Aggression relative to Baseline
Description
Self-report
Time Frame
Weeks 4, 8, and 12
Title
Safety: Change in Video-game Addiction relative to Baseline
Description
Self-report
Time Frame
Weeks 4, 8, and 12
Title
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
Description
Executive Control of Emotion
Time Frame
Baseline, Weeks 4,8, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Woodberry, MSW, Ph.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32237208
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.
Results Reference
derived
Learn more about this trial
Computer-Aided Learning for Managing Stress
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