Bipolar DisorderNCT02613104
Emotion Recognition Modification for Bipolar Disorder
A study testing emotion recognition modification - sad>happy and emotion recognition modification - angry>happy in people with Bipolar Disorder, run by Northwell Health at 1 site in United States.
Trial summary
Previous research suggests that people with bipolar disorder have trouble accurately identifying emotions. The goal of this study is to test a novel intervention, emotion recognition modification (ERM), to help improve the ability of young people with bipolar disorder to identify emotions. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- emotion recognition modification - sad>happy and emotion recognition modification - angry>happy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 16-25 with a bipolar spectrum disorder. Must be English-speaking.
Who cannot join
- Participants who have cognitive impairment, current psychosis, current suicidal intent, or current substance use disorder will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Previous research suggests that people with bipolar disorder have trouble accurately identifying emotions. The goal of this study is to test a novel intervention, emotion recognition modification (ERM), to help improve the ability of young people with bipolar disorder to identify emotions.
Read the detailed description
Procedure: Participants will be recruited through the University Clinic, affiliated psychiatric hospitals and outpatient psychiatric clinics in the area, and public websites. Interested participants will be interviewed on the phone to determine initial eligibility; those who meet criteria will be invited for a comprehensive evaluation.
For potential participants under the age of 18, parents/caregivers will be asked the eligibility questions about their child. If the child meets initial eligibility criteria, both s/he and the parent/caregiver will be invited to the baseline appointment.
The baseline appointment will take place at Zucker Hillside Hospital. Following the informed consent/assent process, participants will be interviewed by a trained research assistant to assess clinical and treatment history, and to determine diagnostic eligibility, using the SCID. Participants who meet eligibility criteria will proceed to complete other baseline measures.
Emotion recognition baseline procedure. The baseline task allows for the measurement of each participants' baseline balance point, the point at which they are equally likely to see a given face as happy or sad (or angry). Each participant will complete 45 trials of the emotion recognition task in which each face from a morph sequence of happy and sad (or angry) faces is presented, the participant is then forced to decide whether a face is sad (or angry) or happy.
Intervention: Once the baseline measures are completed, participants will be randomized to the sad-to-happy condition, the angry-to-happy condition, or a control condition (n =20 per group). Participants in the intervention conditions will complete the training task three times over three in-person sessions. The task will be similar to the baseline procedure; participants will view faces and be asked to judge the expression, however they will now be given feedback (e.g. "Incorrect! That face was happy."), in order to shift the category of happy faces to include those faces two morph steps beyond the participant's baseline balance point. Participants in the control condition will repeat the baseline task, with feedback consistent with their baseline performance (i.e. the faces they judged as happy initially will be called "correct" when judged happy again. The intervention will be administered a total of three times (once at baseline, once at the first follow-up, once at the second follow-up).
Follow-Up: After the final training session, participants will complete the first follow-up. This will consist of the clinician-administered YMRS, as well as online questionnaires, including the LEE, PANAS, GBI, social network task, Perceived Social Support, feasibility questionnaire.
Eight weeks after completing the final training session, participants will return to the research lab for the final follow-up, which will include the following measures, LEE, PANAS, GBI, social network task, Perceived Social Support, emotion recognition task, YMRS, and BDI-II to assess changes in mood episode over the study follow-up period. Participants will also be asked to complete a brief form about whether they liked the intervention and found it convenient to assess burden and feasibility.
- Conditions
- Bipolar Disorder
- Being tested
- emotion recognition modification - sad>happy, emotion recognition modification - sad>happy control, emotion recognition modification - angry>happy, emotion recognition modification - angry>happy control
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotion recognition modification - sad>happyOther
Participants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than sad. The intervention is completed three times.
emotion recognition modification - sad>happy controlOther
Participants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times.
emotion recognition modification - angry>happyOther
Participants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than angry. The intervention is completed three times.
emotion recognition modification - angry>happy controlOther
Participants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times.
| Study group | Role | What they receive |
|---|---|---|
| Sad to Happy | Experimental | emotion recognition modification - sad>happy Receives: Other: emotion recognition modification - sad>happy |
| Sad control | Placebo comparator | emotion recognition modification - sad>happy control Receives: Other: emotion recognition modification - sad>happy control |
| Angry to Happy | Experimental | emotion recognition modification - angry>happy Receives: Other: emotion recognition modification - angry>happy |
| Angry control | Placebo comparator | emotion recognition modification - angry>happy control Receives: Other: emotion recognition modification - angry>happy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in face emotion recognition as assessed by the number of face emotions correctly identified
Ratio of faces identified as happy versus sad/angry
Measured: two months after the completion of the intervention
Secondary outcomes (8)
change in self reported depressed mood as measured by baseline and post intervention
General Behavior Inventory
Measured: following three sessions of the intervention (approximately two weeks)
change in clinician-rated depressed mood as measured by baseline and post intervention scores o
Beck Depression Inventory
Measured: following three sessions of the intervention (approximately two weeks)
change in self-reported depressed mood as measured by baseline and two month follow-up scores
General Behavior Inventory
Measured: two months after completion of intervention
change in clinician-rated depressed mood as measured by baseline and two month follow-up scores
Beck Depression Inventory
Measured: two months after completion of intervention
change in social functioning as measured by the social network questionnaire
Social network questionnaire
Measured: following three sessions of the intervention (approximately two weeks)
change in social functioning as measured by the social network questionnaire at follow-up
Social network questionnaire
Measured: two months after completion of intervention
change in positive affect as measured by the Positive and Negative Affect Scale
PANAS
Measured: following three sessions of the intervention (approximately two weeks)
change in positive affect as measured by the Positive and Negative Affect Scale at follow-up
PANAS
Measured: two months after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Van Meter, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613104
- Sponsor's protocol ID
- 2013-2811
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Penton-Voak IS, Bate H, Lewis G, Munafo MR. Effects of emotion perception training on mood in undergraduate students: randomised controlled trial. Br J Psychiatry. 2012 Jul;201(1):71-2. doi: 10.1192/bjp.bp.111.107086. Epub 2012 Apr 26.
PubMed 22539781Penton-Voak IS, Thomas J, Gage SH, McMurran M, McDonald S, Munafo MR. Increasing recognition of happiness in ambiguous facial expressions reduces anger and aggressive behavior. Psychol Sci. 2013 May;24(5):688-97. doi: 10.1177/0956797612459657. Epub 2013 Mar 26.
PubMed 23531485
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Recognition Modification for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02613104
- Acronym / sponsor ID
- 2013-2811
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 Nov 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.
Previous research suggests that people with bipolar disorder have trouble accurately identifying emotions. The goal of this study is to test a novel intervention, emotion recognition modification (ERM), to help improve the ability of young people with bipolar disorder to identify emotions.
Detailed description
Procedure: Participants will be recruited through the University Clinic, affiliated psychiatric hospitals and outpatient psychiatric clinics in the area, and public websites. Interested participants will be interviewed on the phone to determine initial eligibility; those who meet criteria will be invited for a comprehensive evaluation.
For potential participants under the age of 18, parents/caregivers will be asked the eligibility questions about their child. If the child meets initial eligibility criteria, both s/he and the parent/caregiver will be invited to the baseline appointment.
The baseline appointment will take place at Zucker Hillside Hospital. Following the informed consent/assent process, participants will be interviewed by a trained research assistant to assess clinical and treatment history, and to determine diagnostic eligibility, using the SCID. Participants who meet eligibility criteria will proceed to complete other baseline measures.
Emotion recognition baseline procedure. The baseline task allows for the measurement of each participants' baseline balance point, the point at which they are equally likely to see a given face as happy or sad (or angry). Each participant will complete 45 trials of the emotion recognition task in which each face from a morph sequence of happy and sad (or angry) faces is presented, the participant is then forced to decide whether a face is sad (or angry) or happy.
Intervention: Once the baseline measures are completed, participants will be randomized to the sad-to-happy condition, the angry-to-happy condition, or a control condition (n =20 per group). Participants in the intervention conditions will complete the training task three times over three in-person sessions. The task will be similar to the baseline procedure; participants will view faces and be asked to judge the expression, however they will now be given feedback (e.g. "Incorrect! That face was happy."), in order to shift the category of happy faces to include those faces two morph steps beyond the participant's baseline balance point. Participants in the control condition will repeat the baseline task, with feedback consistent with their baseline performance (i.e. the faces they judged as happy initially will be called "correct" when judged happy again. The intervention will be administered a total of three times (once at baseline, once at the first follow-up, once at the second follow-up).
Follow-Up: After the final training session, participants will complete the first follow-up. This will consist of the clinician-administered YMRS, as well as online questionnaires, including the LEE, PANAS, GBI, social network task, Perceived Social Support, feasibility questionnaire.
Eight weeks after completing the final training session, participants will return to the research lab for the final follow-up, which will include the following measures, LEE, PANAS, GBI, social network task, Perceived Social Support, emotion recognition task, YMRS, and BDI-II to assess changes in mood episode over the study follow-up period. Participants will also be asked to complete a brief form about whether they liked the intervention and found it convenient to assess burden and feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sad to Happy | Experimental | Other: emotion recognition modification - sad>happyemotion recognition modification - sad>happy |
| Sad control | Placebo comparator | Other: emotion recognition modification - sad>happy controlemotion recognition modification - sad>happy control |
| Angry to Happy | Experimental | Other: emotion recognition modification - angry>happyemotion recognition modification - angry>happy |
| Angry control | Placebo comparator | Other: emotion recognition modification - angry>happy controlemotion recognition modification - angry>happy control |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Aged 16-25 with a bipolar spectrum disorder. Must be English-speaking.
Key exclusion criteria (1 listed)
- Participants who have cognitive impairment, current psychosis, current suicidal intent, or current substance use disorder will be excluded.
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 |
|---|---|---|
| emotion recognition modification - sad>happyParticipants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than sad. The intervention is completed three times. | Other | Sad to Happy |
| emotion recognition modification - sad>happy controlParticipants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times. | Other | Sad control |
| emotion recognition modification - angry>happyParticipants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than angry. The intervention is completed three times. | Other | Angry to Happy |
| emotion recognition modification - angry>happy controlParticipants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times. | Other | Angry control |
Primary outcome
change in face emotion recognition as assessed by the number of face emotions correctly identified
Time frame: two months after the completion of the intervention
Ratio of faces identified as happy versus sad/angry
8 secondary outcomes
change in self reported depressed mood as measured by baseline and post intervention
Time frame: following three sessions of the intervention (approximately two weeks)
change in clinician-rated depressed mood as measured by baseline and post intervention scores o
Time frame: following three sessions of the intervention (approximately two weeks)
change in self-reported depressed mood as measured by baseline and two month follow-up scores
Time frame: two months after completion of intervention
change in clinician-rated depressed mood as measured by baseline and two month follow-up scores
Time frame: two months after completion of intervention
change in social functioning as measured by the social network questionnaire
Time frame: following three sessions of the intervention (approximately two weeks)
change in social functioning as measured by the social network questionnaire at follow-up
Time frame: two months after completion of intervention
change in positive affect as measured by the Positive and Negative Affect Scale
Time frame: following three sessions of the intervention (approximately two weeks)
change in positive affect as measured by the Positive and Negative Affect Scale at follow-up
Time frame: two months after completion of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 22539781Penton-Voak IS, Bate H, Lewis G, Munafo MR. Effects of emotion perception training on mood in undergraduate students: randomised controlled trial. Br J Psychiatry. 2012 Jul;201(1):71-2. doi: 10.1192/bjp.bp.111.107086. Epub 2012 Apr 26.
- Background: PubMed 23531485Penton-Voak IS, Thomas J, Gage SH, McMurran M, McDonald S, Munafo MR. Increasing recognition of happiness in ambiguous facial expressions reduces anger and aggressive behavior. Psychol Sci. 2013 May;24(5):688-97. doi: 10.1177/0956797612459657. Epub 2013 Mar 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotion recognition modification - sad>happy and emotion recognition modification - angry>happy in people with Bipolar Disorder, run by Northwell Health 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Oct 2021. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
change in face emotion recognition as assessed by the number of face emotions correctly identified (time frame: two months after the completion of the intervention). 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 NCT02613104, which also lists 2 linked publications.
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 6 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.