NCT02531243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

July 13, 2015

Last Update Submit

February 22, 2018

Conditions

Psychosis

Keywords

prodromefamily therapyclinical high risk

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (9)

  • Change in Perceived Stress relative to Baseline

    Weeks 4, 8, and 12 Assessments

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

    Weeks 4, 8, 12 Assessments

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

    Weeks 4, 8, 12 Assessments

  • Positive Symptom Score Change relative to Baseline

    Weeks 4,8, and 12 Assessments

  • Change in Social and Role Functioning relative to Baseline

    Weeks 4, 8, and 12 Assessments

  • +4 more secondary outcomes

Study Arms (1)

CALMS

EXPERIMENTAL

12 session family therapy using multi-user biofeedback games

Behavioral: CALMS

Interventions

CALMSBEHAVIORAL

Family Therapy; Multi-user Biofeedback Videogames

CALMS

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 32237208DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Kristen Woodberry, MSW, Ph.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Program for Psychosocial Protective Mechanisms

Study Record Dates

First Submitted

July 13, 2015

First Posted

August 24, 2015

Study Start

September 1, 2015

Primary Completion

January 5, 2018

Study Completion

January 5, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)