PsychosisCALMSNCT02531243
Computer-Aided Learning for Managing Stress
A study testing CALMS in people with Psychosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Psychosis
- What is being tested?
- CALMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 5 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- CALMS
- Keywords
- prodrome, family therapy, clinical high risk
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALMSBehavioural
Family Therapy; Multi-user Biofeedback Videogames
| Study group | Role | What they receive |
|---|---|---|
| CALMS | Experimental | 12 session family therapy using multi-user biofeedback games Receives: Behavioral: CALMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Percent of referred who consent and meet study criteria
Enrollment
Measured: Up to six months
Feasibility: Percent of 12 sessions completed
Engagement: Percent of sessions completed by consented and eligible participants
Measured: Up to six months
Feasibility: Counts of premature termination of intervention
Measured: Up to six months
Feasibility: Self-report of Credibility/Satisfaction
Individual and family member self-report
Measured: 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
Measured: 12 week assessment or last assessment completed
Secondary outcomes (9)
Change in Perceived Stress relative to Baseline
Self-report via Perceived Stress Scale
Measured: Weeks 4, 8, and 12 Assessments
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
Measured: Weeks 4, 8, 12 Assessments
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
Measured: Weeks 4, 8, 12 Assessments
Positive Symptom Score Change relative to Baseline
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Measured: Weeks 4,8, and 12 Assessments
Change in Social and Role Functioning relative to Baseline
Global Functioning: Social \& Role Scales;
Measured: Weeks 4, 8, and 12 Assessments
Change in Global Functioning relative to Baseline
SIPS Global Assessment of Functioning
Measured: Weeks 4, 8, and 12 Assessments
Safety: Change in Hostility/Aggression relative to Baseline
Self-report
Measured: Weeks 4, 8, and 12
Safety: Change in Video-game Addiction relative to Baseline
Self-report
Measured: Weeks 4, 8, and 12
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
Executive Control of Emotion
Measured: Baseline, Weeks 4,8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Boston Children's Hospital
- Responsible party
- Principal investigator, Kristen Woodberry, Beth Israel Deaconess Medical Center
- Investigators
- Kristen Woodberry, MSW, Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531243
- Sponsor's protocol ID
- 2012P000377
- Other IDs
- K23MH102358
- Acronym
- CALMS
- Status last verified
- Feb 2018
- First submitted
- 13 Jul 2015
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32237208
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
- ClinicalTrials.gov ID
- NCT02531243
- Acronym / sponsor ID
- CALMS / 2012P000377
- Conditions
- Psychosis
- Keywords
- prodrome, family therapy, clinical high risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Boston Children's Hospital
- Study start
- Sep 2015
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALMS | Experimental | Behavioral: CALMS12 session family therapy using multi-user biofeedback games |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALMSFamily Therapy; Multi-user Biofeedback Videogames | Behavioural | CALMS |
Primary outcome
Feasibility: Percent of referred who consent and meet study criteria
Time frame: Up to six months
Enrollment
Feasibility: Percent of 12 sessions completed
Time frame: Up to six months
Engagement: Percent of sessions completed by consented and eligible participants
Feasibility: Counts of premature termination of intervention
Time frame: Up to six months
Feasibility: Self-report of Credibility/Satisfaction
Time frame: 12 week assessment or last assessment completed
Individual and family member self-report
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
9 secondary outcomes
Change in Perceived Stress relative to Baseline
Time frame: Weeks 4, 8, and 12 Assessments
Change relative to Baseline in Youth Perceptions of Relationship with Family Member
Time frame: Weeks 4, 8, 12 Assessments
Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
Time frame: Weeks 4, 8, 12 Assessments
Positive Symptom Score Change relative to Baseline
Time frame: Weeks 4,8, and 12 Assessments
Change in Social and Role Functioning relative to Baseline
Time frame: Weeks 4, 8, and 12 Assessments
Change in Global Functioning relative to Baseline
Time frame: Weeks 4, 8, and 12 Assessments
Safety: Change in Hostility/Aggression relative to Baseline
Time frame: Weeks 4, 8, and 12
Safety: Change in Video-game Addiction relative to Baseline
Time frame: Weeks 4, 8, and 12
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
Time frame: Baseline, Weeks 4,8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 32237208Woodberry 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Woodberry, MSW, Ph.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALMS in people with Psychosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Percent of referred who consent and meet study criteria (time frame: Up to six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.