Trial Outcomes & Findings for The Emotion Builder: An Intervention for Emotional Deficits After Brain Injury (NCT NCT02432300)

Last Updated: 2017-11-22

Results Overview

This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Week 6

Results posted on

2017-11-22

Participant Flow

Participants were only enrolled in the treatment if they were found to have met the criteria for moderate to severe alexithymia on the Toronto Alexithymia Scale 20 (\>=52).

Participant milestones

Participant milestones
Measure	Treatment Group (Emotion Builder) The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group (Emotion Builder) n=17 Participants The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
Age, Continuous	46.12 years STANDARD_DEVIATION 11.41 • n=17 Participants
Sex: Female, Male Female	4 Participants n=17 Participants
Sex: Female, Male Male	13 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=17 Participants
Race (NIH/OMB) Asian	0 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	0 Participants n=17 Participants
Race (NIH/OMB) White	17 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=17 Participants
Toronto Alexithymia Scale	61.54 units on a scale STANDARD_DEVIATION 7.26 • n=13 Participants • Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13).
Levels of Emotional Awareness Scale	36.92 units on a scale STANDARD_DEVIATION 7.88 • n=13 Participants • Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13).
PHQ 9 (Depression)	10.77 units on a scale STANDARD_DEVIATION 4.82 • n=13 Participants • Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13).
Trait Anxiety (State Trait Anxiety Inventory)	68.38 T score STANDARD_DEVIATION 11.45 • n=13 Participants • Because 4 participants withdrew, we provide only baseline data here for those who completed the intervention (n=13).

PRIMARY outcome

Timeframe: Week 6

Outcome measures

Outcome measures
Measure	Treatment Group (Emotion Builder) n=13 Participants The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
Toronto Alexithymia Scale-20 (TAS-20)	52.54 units on a scale Standard Deviation 11.95

PRIMARY outcome

Timeframe: Week 6

The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants must respond how they think they would feel and how another person would feel in response to the hypothetical scenario. The more discrete emotions (e.g., bad vs sad) receive higher points, as well as blended emotions (e.g. sad and angry). There are 10 items on this measure. The minimum score for each item is 0 and the max score for each item is 5. The item scores are summed to calculate a total score. Thus, the total scores range from 0-50; 0=lowest awareness and 50=highest awareness. A computerized scoring system and parallel forms were used.

Outcome measures

Outcome measures
Measure	Treatment Group (Emotion Builder) n=13 Participants The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
Levels of Emotional Awareness Scale (LEAS)	44.23 units on a scale Standard Deviation 5.23

SECONDARY outcome

Timeframe: Week 6

The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression. The 9 items describe problems associated with depression, and participants must rate how often they have been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, which higher scores indicating greater depression.

Outcome measures

Outcome measures
Measure	Treatment Group (Emotion Builder) n=13 Participants The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression	9.69 units on a scale Standard Deviation 5.25

SECONDARY outcome

Timeframe: Week 6

The STAI is a self-report measure of state and trait anxiety (20 items each). The trait anxiety subscale was the variable of interest for this study. Higher scores indicate more trait or state anxiety. Scores for each scale range from 20-80, with higher scores indicating greater anxiety. The raw scores were converted into T scores using age and gender norms provided by the authors for the STAI. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Higher T scores were still indicative of higher anxiety. We reported T scores for trait anxiety.

Outcome measures

Outcome measures
Measure	Treatment Group (Emotion Builder) n=13 Participants The intervention was a web-based treatment program called the Emotion Builder that was delivered by a clinician research assistant individually to participants. Emotion Builder: Total of 8 therapy sessions (60-90 minutes each) over approximately four (4) weeks (2 sessions a week). The objective of these sessions were to increase emotional awareness and labeling. Lessons included exercises designed to build emotional vocabulary, lessons to help differentiate emotions, activities to enhance attention to changes in body states associated with emotional responses (emotional arousal), and virtual videos simulating emotional scenarios for practicing lessons learned.
State Trait Anxiety Inventory (STAI)	61.54 units on a scale Standard Deviation 12.08

Adverse Events

Treatment Group (Emotion Builder)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group (Emotion Builder) n=17 participants at risk 8 sessions of a web-based treatment, each lasting 60-90 minutes, twice per week over 4 weeks with a clinician research assistant. This treatment aimed to improve emotional awareness and labeling.
Psychiatric disorders Emotional Distress	5.9% 1/17 • Number of events 1 • One year. From the start of participant enrollment until the last day of testing.

Additional Information

Dawn Neumann

EmotEd, LLC

Phone: 716-713-5048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place