Emotion Recognition Modification for Bipolar Disorder

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.

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: emotion recognition modification - sad>happy; Other: emotion recognition modification - sad>happy control; Other: emotion recognition modification - angry>happy; Other: emotion recognition modification - angry>happy control

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Zucker Hillside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sad to Happy; emotion recognition modification - sad>happy	Other: emotion recognition modification - sad>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 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.
Placebo Comparator: Sad control; emotion recognition modification - sad>happy control	Other: emotion recognition modification - sad>happy control; 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.
Experimental: Angry to Happy; emotion recognition modification - angry>happy	Other: emotion recognition modification - angry>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 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.
Placebo Comparator: Angry control; emotion recognition modification - angry>happy control	Other: emotion recognition modification - angry>happy 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 placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in self reported depressed mood as measured by baseline and post intervention	General Behavior Inventory	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	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	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	two months after completion of intervention
change in social functioning as measured by the social network questionnaire	Social network questionnaire	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	two months after completion of intervention
change in positive affect as measured by the Positive and Negative Affect Scale	PANAS	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	two months after completion of intervention

Collaborators and Investigators

• Sponsor: Northwell Health

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 2013-2811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No