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Emotion Recognition Modification for Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
emotion recognition modification - sad>happy
emotion recognition modification - sad>happy control
emotion recognition modification - angry>happy
emotion recognition modification - angry>happy control
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Sad to Happy

Sad control

Angry to Happy

Angry control

Arm Description

emotion recognition modification - sad>happy

emotion recognition modification - sad>happy control

emotion recognition modification - angry>happy

emotion recognition modification - angry>happy control

Outcomes

Primary Outcome Measures

change in face emotion recognition as assessed by the number of face emotions correctly identified
Ratio of faces identified as happy versus sad/angry

Secondary Outcome Measures

change in self reported depressed mood as measured by baseline and post intervention
General Behavior Inventory
change in clinician-rated depressed mood as measured by baseline and post intervention scores o
Beck Depression Inventory
change in self-reported depressed mood as measured by baseline and two month follow-up scores
General Behavior Inventory
change in clinician-rated depressed mood as measured by baseline and two month follow-up scores
Beck Depression Inventory
change in social functioning as measured by the social network questionnaire
Social network questionnaire
change in social functioning as measured by the social network questionnaire at follow-up
Social network questionnaire
change in positive affect as measured by the Positive and Negative Affect Scale
PANAS
change in positive affect as measured by the Positive and Negative Affect Scale at follow-up
PANAS

Full Information

First Posted
November 18, 2015
Last Updated
October 5, 2021
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT02613104
Brief Title
Emotion Recognition Modification for Bipolar Disorder
Official Title
Emotion Recognition Modification for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sad to Happy
Arm Type
Experimental
Arm Description
emotion recognition modification - sad>happy
Arm Title
Sad control
Arm Type
Placebo Comparator
Arm Description
emotion recognition modification - sad>happy control
Arm Title
Angry to Happy
Arm Type
Experimental
Arm Description
emotion recognition modification - angry>happy
Arm Title
Angry control
Arm Type
Placebo Comparator
Arm Description
emotion recognition modification - angry>happy control
Intervention Type
Other
Intervention Name(s)
emotion recognition modification - sad>happy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
emotion recognition modification - sad>happy control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
emotion recognition modification - angry>happy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
emotion recognition modification - angry>happy control
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in face emotion recognition as assessed by the number of face emotions correctly identified
Description
Ratio of faces identified as happy versus sad/angry
Time Frame
two months after the completion of the intervention
Secondary Outcome Measure Information:
Title
change in self reported depressed mood as measured by baseline and post intervention
Description
General Behavior Inventory
Time Frame
following three sessions of the intervention (approximately two weeks)
Title
change in clinician-rated depressed mood as measured by baseline and post intervention scores o
Description
Beck Depression Inventory
Time Frame
following three sessions of the intervention (approximately two weeks)
Title
change in self-reported depressed mood as measured by baseline and two month follow-up scores
Description
General Behavior Inventory
Time Frame
two months after completion of intervention
Title
change in clinician-rated depressed mood as measured by baseline and two month follow-up scores
Description
Beck Depression Inventory
Time Frame
two months after completion of intervention
Title
change in social functioning as measured by the social network questionnaire
Description
Social network questionnaire
Time Frame
following three sessions of the intervention (approximately two weeks)
Title
change in social functioning as measured by the social network questionnaire at follow-up
Description
Social network questionnaire
Time Frame
two months after completion of intervention
Title
change in positive affect as measured by the Positive and Negative Affect Scale
Description
PANAS
Time Frame
following three sessions of the intervention (approximately two weeks)
Title
change in positive affect as measured by the Positive and Negative Affect Scale at follow-up
Description
PANAS
Time Frame
two months after completion of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22539781
Citation
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.
Results Reference
background
PubMed Identifier
23531485
Citation
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.
Results Reference
background

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Emotion Recognition Modification for Bipolar Disorder

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