NCT02613104

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

4 years

First QC Date

November 18, 2015

Last Update Submit

October 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in face emotion recognition as assessed by the number of face emotions correctly identified

    Ratio of faces identified as happy versus sad/angry

    two months after the completion of the intervention

Secondary Outcomes (8)

  • change in self reported depressed mood as measured by baseline and post intervention

    following three sessions of the intervention (approximately two weeks)

  • change in clinician-rated depressed mood as measured by baseline and post intervention scores o

    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

    two months after completion of intervention

  • change in clinician-rated depressed mood as measured by baseline and two month follow-up scores

    two months after completion of intervention

  • change in social functioning as measured by the social network questionnaire

    following three sessions of the intervention (approximately two weeks)

  • +3 more secondary outcomes

Study Arms (4)

Sad to Happy

EXPERIMENTAL

emotion recognition modification - sad\>happy

Other: emotion recognition modification - sad>happy

Sad control

PLACEBO COMPARATOR

emotion recognition modification - sad\>happy control

Other: emotion recognition modification - sad>happy control

Angry to Happy

EXPERIMENTAL

emotion recognition modification - angry\>happy

Other: emotion recognition modification - angry>happy

Angry control

PLACEBO COMPARATOR

emotion recognition modification - angry\>happy control

Other: emotion recognition modification - angry>happy control

Interventions

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.

Sad to Happy

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.

Sad control

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.

Angry to Happy

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.

Angry control

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 16-25 with a bipolar spectrum disorder. Must be English-speaking.

You may not qualify if:

  • Participants who have cognitive impairment, current psychosis, current suicidal intent, or current substance use disorder will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Related Publications (2)

  • 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.

    PMID: 22539781BACKGROUND
  • Penton-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.

    PMID: 23531485BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 24, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations