Clinical trial NCT02613104: Emotion Recognition Modification for Bipolar Disorder
Official title: Emotion Recognition Modification for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in face emotion recognition as assessed by the number of face emotions correctly identified
timeFrame: two months after the completion of the intervention
Secondary outcomes:
measure: change in self reported depressed mood as measured by baseline and post intervention
timeFrame: following three sessions of the intervention (approximately two weeks)
measure: change in clinician-rated depressed mood as measured by baseline and post intervention scores o
timeFrame: following three sessions of the intervention (approximately two weeks)
measure: change in self-reported depressed mood as measured by baseline and two month follow-up scores
timeFrame: two months after completion of intervention
measure: change in clinician-rated depressed mood as measured by baseline and two month follow-up scores
timeFrame: two months after completion of intervention
measure: change in social functioning as measured by the social network questionnaire
timeFrame: following three sessions of the intervention (approximately two weeks)
measure: change in social functioning as measured by the social network questionnaire at follow-up
timeFrame: two months after completion of intervention
measure: change in positive affect as measured by the Positive and Negative Affect Scale
timeFrame: following three sessions of the intervention (approximately two weeks)
measure: change in positive affect as measured by the Positive and Negative Affect Scale at follow-up
timeFrame: two months after completion of intervention
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
References:
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.
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.