Trial Outcomes & Findings for Uniting Couples in the Treatment of Binge-Eating Disorder (NCT NCT03784820)
NCT ID: NCT03784820
Last Updated: 2023-04-11
Results Overview
Binge-eating abstinence is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) and is the number of participants across study time points achieving abstinence from objective binge eating over the past 28 days. The EDE-Q measure replaces the measure in the protocol to capture a month of abstinence. The weekly binge measure was unsuitable upon review of the data because the 4 times weekly measures did not capture an exact 4-week time frame because of therapy scheduling irregularities, as verified by date-stamps of measure completion. Also, the weekly binge measure captured the past 7 days and was administered every session and once at other timepoints.
COMPLETED
NA
44 participants
Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)
2023-04-11
Participant Flow
Participants were recruited between September 2018 to January 2021 from local physician offices, social media, advertisements, and local listservs. Potential participants were asked to contact the Research Coordinator for more information. Potential participants completed a screening questionnaire by phone with the Research Coordinator. The setting for the study was an outpatient clinic at the University of North Carolina at Chapel Hill.
After consenting to participate and completing an initial phone screening, participants were asked to complete a pre-treatment assessment consisting of electronic questionnaires and an in-person interview to determine study eligibility. The patient with binge-eating disorder (BED) in each couple had to provide written certification from their primary care provider (PCP) that their health status was suitable for this study. After determining eligibility, patients were randomized.
Participant milestones
| Measure |
CBT-E - Patients
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
CBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
|
CBT-E - Partners
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
CBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
|
UNITE - Patients
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
UNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
|
UNITE - Partners
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
UNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
|
Overall Study
Pre (T0) Intent-to-Treat (ITT)
|
11
|
11
|
11
|
11
|
|
Overall Study
Mid-Treatment (T1) Intent-to-Treat (ITT)
|
10
|
7
|
9
|
9
|
|
Overall Study
Post (T2) Intent-to-Treat (ITT)
|
7
|
6
|
9
|
9
|
|
Overall Study
3 Month Fup (T3) Intent-to-Treat (ITT)
|
6
|
6
|
9
|
9
|
|
Overall Study
6 Month Fup (T4) Intent-to-Treat (ITT)
|
6
|
6
|
8
|
8
|
|
Overall Study
Pre (T0) Modified Intent-to-Treat (mITT)
|
11
|
11
|
10
|
10
|
|
Overall Study
Mid-Treatment (T1) Modified Intent-to-Treat (mITT)
|
10
|
7
|
8
|
8
|
|
Overall Study
Post (T2) Modified Intent-to-Treat (mITT)
|
7
|
6
|
8
|
8
|
|
Overall Study
3 Month Fup (T3) Modified Intent-to-Treat (mITT)
|
6
|
6
|
8
|
8
|
|
Overall Study
6 Month Fup (T4) Modified Intent-to-Treat (mITT)
|
6
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
3
|
Reasons for withdrawal
| Measure |
CBT-E - Patients
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
CBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
|
CBT-E - Partners
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
CBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
|
UNITE - Patients
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
UNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
|
UNITE - Partners
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
UNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
3
|
3
|
Baseline Characteristics
Subtotals for patients and partners are provided.
Baseline characteristics by cohort
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
CBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
|
UNITE
n=22 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
UNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.00 years
STANDARD_DEVIATION 11.97 • n=22 Participants
|
40.27 years
STANDARD_DEVIATION 10.31 • n=22 Participants
|
41.14 years
STANDARD_DEVIATION 10.93 • n=44 Participants
|
|
Sex: Female, Male
Patients · Female
|
3 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
2 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
5 Participants
n=22 Participants • Subtotals for patients and partners are provided.
|
|
Sex: Female, Male
Patients · Male
|
8 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
9 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
17 Participants
n=22 Participants • Subtotals for patients and partners are provided.
|
|
Sex: Female, Male
Partners · Female
|
7 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
8 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
15 Participants
n=22 Participants • Subtotals for patients and partners are provided.
|
|
Sex: Female, Male
Partners · Male
|
4 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
3 Participants
n=11 Participants • Subtotals for patients and partners are provided.
|
7 Participants
n=22 Participants • Subtotals for patients and partners are provided.
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
2 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
20 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
0 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
0 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Ethnicity (NIH/OMB)
Partners · Hispanic or Latino
|
0 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
1 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Ethnicity (NIH/OMB)
Partners · Not Hispanic or Latino
|
11 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
21 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Ethnicity (NIH/OMB)
Partners · Unknown or Not Reported
|
0 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
0 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
0 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Race/Ethnicity, Customized
Patients · Race: White
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
20 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Race/Ethnicity, Customized
Patients · Race: Other
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
2 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Race/Ethnicity, Customized
Partners · Race: White
|
10 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
9 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
19 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Race/Ethnicity, Customized
Partners · Race: Other
|
1 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
2 Participants
n=11 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
3 Participants
n=22 Participants • The overall number of participants is equal to the number of patients and partners combined.
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Only patients completed this measure.
Binge-eating abstinence is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) and is the number of participants across study time points achieving abstinence from objective binge eating over the past 28 days. The EDE-Q measure replaces the measure in the protocol to capture a month of abstinence. The weekly binge measure was unsuitable upon review of the data because the 4 times weekly measures did not capture an exact 4-week time frame because of therapy scheduling irregularities, as verified by date-stamps of measure completion. Also, the weekly binge measure captured the past 7 days and was administered every session and once at other timepoints.
Outcome measures
| Measure |
CBT-E
n=10 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=8 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
Mid-Treatment (T1)
|
2 Participants
|
1 Participants
|
|
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
Post (T2)
|
5 Participants
|
4 Participants
|
|
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
3 Month Fup (T3)
|
5 Participants
|
5 Participants
|
|
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
6 Month Fup (T4)
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Only patients completed this measure.
Binge-eating frequency is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) number of objective binge episodes item which spans the past 28 days. Range is 0-no upper limit, with higher frequency indicative of more severe pathology. The EDE-Q measure replaces the originally planned measure in the protocol.
Outcome measures
| Measure |
CBT-E
n=11 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=10 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
Pre (T0)
|
12.45 number of binge-eating episodes
Standard Deviation 9.18
|
14.50 number of binge-eating episodes
Standard Deviation 15.30
|
|
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
Mid-Treatment (T1)
|
6.70 number of binge-eating episodes
Standard Deviation 5.31
|
3.88 number of binge-eating episodes
Standard Deviation 2.42
|
|
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
Post (T2)
|
1.00 number of binge-eating episodes
Standard Deviation 1.73
|
1.50 number of binge-eating episodes
Standard Deviation 1.85
|
|
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
3 Month Fup (T3)
|
0.83 number of binge-eating episodes
Standard Deviation 2.04
|
0.75 number of binge-eating episodes
Standard Deviation 1.16
|
|
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
6 Month Fup (T4)
|
0.50 number of binge-eating episodes
Standard Deviation 0.84
|
0.57 number of binge-eating episodes
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Only patients completed this measure.
Eating disorder symptomatology is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) global score. This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. The global score is obtained by summing the four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) and then dividing this sum by the number of subscales (i.e., four). The global score range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).
Outcome measures
| Measure |
CBT-E
n=11 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=10 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
Pre (T0)
|
2.97 score on a scale
Standard Deviation 1.14
|
3.53 score on a scale
Standard Deviation 0.68
|
|
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
Mid-Treatment (T1)
|
1.89 score on a scale
Standard Deviation 1.16
|
2.81 score on a scale
Standard Deviation 0.70
|
|
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
Post (T2)
|
1.77 score on a scale
Standard Deviation 0.47
|
1.82 score on a scale
Standard Deviation 0.63
|
|
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
3 Month Fup (T3)
|
1.38 score on a scale
Standard Deviation 0.82
|
1.66 score on a scale
Standard Deviation 0.79
|
|
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
6 Month Fup (T4)
|
1.18 score on a scale
Standard Deviation 0.73
|
1.40 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Binge-Eating Scale is a 16-item self-report scale that assesses behavioral, affective, and attitudinal components of the subject experience of binge-eating. Item responses range from 0 to 3, with a total score range of 0 to 48. Higher sum scores indicate greater binge-eating severity and associated emotional distress.
Outcome measures
| Measure |
CBT-E
n=11 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=10 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
6 Month Fup (T4)
|
7.00 score on a scale
Standard Deviation 8.10
|
9.64 score on a scale
Standard Deviation 3.96
|
|
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
Pre (T0)
|
25.40 score on a scale
Standard Deviation 6.60
|
28.83 score on a scale
Standard Deviation 7.02
|
|
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
Mid-Treatment (T1)
|
15.17 score on a scale
Standard Deviation 8.37
|
17.76 score on a scale
Standard Deviation 6.20
|
|
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
Post (T2)
|
9.56 score on a scale
Standard Deviation 4.60
|
11.30 score on a scale
Standard Deviation 5.98
|
|
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
3 Month Fup (T3)
|
7.17 score on a scale
Standard Deviation 6.37
|
8.17 score on a scale
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)Population: Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The total score range is 0 to 40. Higher scores indicate greater severity of compulsive behaviors and preoccupations related to binge-eating.
Outcome measures
| Measure |
CBT-E
n=11 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=10 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
Pre (T0)
|
17.91 score on a scale
Standard Deviation 3.33
|
17.10 score on a scale
Standard Deviation 4.75
|
|
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
Mid-Treatment (T1)
|
14.11 score on a scale
Standard Deviation 2.98
|
13.13 score on a scale
Standard Deviation 4.82
|
|
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
Post (T2)
|
6.32 score on a scale
Standard Deviation 4.24
|
7.38 score on a scale
Standard Deviation 4.44
|
|
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
6 Month Fup (T4)
|
4.67 score on a scale
Standard Deviation 6.41
|
6.50 score on a scale
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures of depressive symptoms. It includes 21 self-report items. Total scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
18.82 score on a scale
Standard Deviation 8.53
|
19.50 score on a scale
Standard Deviation 8.49
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
10.90 score on a scale
Standard Deviation 6.79
|
14.88 score on a scale
Standard Deviation 8.49
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
7.14 score on a scale
Standard Deviation 4.22
|
12.00 score on a scale
Standard Deviation 7.70
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
7.33 score on a scale
Standard Deviation 4.89
|
9.13 score on a scale
Standard Deviation 7.53
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
4.33 score on a scale
Standard Deviation 4.27
|
7.43 score on a scale
Standard Deviation 3.95
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
6.18 score on a scale
Standard Deviation 4.75
|
6.00 score on a scale
Standard Deviation 5.70
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
5.43 score on a scale
Standard Deviation 5.03
|
5.75 score on a scale
Standard Deviation 7.63
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
7.50 score on a scale
Standard Deviation 8.04
|
5.88 score on a scale
Standard Deviation 5.54
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
8.00 score on a scale
Standard Deviation 8.02
|
5.50 score on a scale
Standard Deviation 6.50
|
|
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
7.67 score on a scale
Standard Deviation 9.65
|
5.29 score on a scale
Standard Deviation 8.08
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed
The Beck-Anxiety Inventory-II (BAI) is a self-report measure that assesses different aspects of the anxiety experience (e.g., physiological, cognitive, behavioral). The total score ranges from 0 to 63 with higher scores indicative of greater anxiety symptoms.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
8.18 score on a scale
Standard Deviation 4.92
|
13.40 score on a scale
Standard Deviation 8.80
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
8.00 score on a scale
Standard Deviation 5.46
|
12.25 score on a scale
Standard Deviation 12.70
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
9.43 score on a scale
Standard Deviation 7.02
|
5.71 score on a scale
Standard Deviation 4.19
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
5.33 score on a scale
Standard Deviation 6.44
|
9.88 score on a scale
Standard Deviation 9.30
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
3.83 score on a scale
Standard Deviation 4.12
|
4.71 score on a scale
Standard Deviation 4.72
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
2.64 score on a scale
Standard Deviation 3.44
|
6.00 score on a scale
Standard Deviation 7.45
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
4.14 score on a scale
Standard Deviation 5.76
|
9.75 score on a scale
Standard Deviation 13.86
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
4.00 score on a scale
Standard Deviation 3.29
|
6.13 score on a scale
Standard Deviation 10.01
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
2.50 score on a scale
Standard Deviation 3.27
|
5.13 score on a scale
Standard Deviation 8.48
|
|
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
3.17 score on a scale
Standard Deviation 4.17
|
2.14 score on a scale
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Difficulties in Emotion Regulation Scale is a 36-item self-report scale that assesses emotion regulation. Item responses range from 1 to 5, with a total score range of 36 to 180. Higher scores indicate more difficulties in emotion regulation.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
85.73 score on a scale
Standard Deviation 19.06
|
97.60 score on a scale
Standard Deviation 25.36
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
77.60 score on a scale
Standard Deviation 19.72
|
90.13 score on a scale
Standard Deviation 23.34
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
79.00 score on a scale
Standard Deviation 17.82
|
73.71 score on a scale
Standard Deviation 16.68
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
66.17 score on a scale
Standard Deviation 21.25
|
74.88 score on a scale
Standard Deviation 21.45
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
66.00 score on a scale
Standard Deviation 20.38
|
72.14 score on a scale
Standard Deviation 18.46
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
76.18 score on a scale
Standard Deviation 23.46
|
64.50 score on a scale
Standard Deviation 16.22
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
65.86 score on a scale
Standard Deviation 23.74
|
66.63 score on a scale
Standard Deviation 17.48
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
69.67 score on a scale
Standard Deviation 24.86
|
68.25 score on a scale
Standard Deviation 19.65
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
72.33 score on a scale
Standard Deviation 24.47
|
66.00 score on a scale
Standard Deviation 17.34
|
|
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
69.17 score on a scale
Standard Deviation 18.76
|
61.43 score on a scale
Standard Deviation 16.40
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The partner version of the Difficulties in Emotion Regulation Scale is an 8-item modified version of the DERS. It is a self-report scale that assesses perceptions of one's partner's emotion regulation ability and skills. Three items from the Impulse Control Difficulties (ICD) and 5 items from the Emotion Regulation Strategies (ERS) subscale were administered. Item responses range from 1 to 5 and the total score is the sum of the items. The total score range is 8 to 40. Higher scores indicate more (perceived) difficulties in one's partner's emotion regulation.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
15.36 score on a scale
Standard Deviation 5.52
|
16.60 score on a scale
Standard Deviation 5.85
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
13.89 score on a scale
Standard Deviation 5.58
|
19.38 score on a scale
Standard Deviation 8.37
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
15.86 score on a scale
Standard Deviation 4.14
|
16.71 score on a scale
Standard Deviation 5.35
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
13.83 score on a scale
Standard Deviation 4.45
|
18.38 score on a scale
Standard Deviation 6.99
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
15.17 score on a scale
Standard Deviation 6.91
|
18.29 score on a scale
Standard Deviation 8.69
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
20.73 score on a scale
Standard Deviation 8.60
|
15.40 score on a scale
Standard Deviation 4.95
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
22.71 score on a scale
Standard Deviation 10.40
|
16.63 score on a scale
Standard Deviation 5.10
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
19.17 score on a scale
Standard Deviation 8.84
|
15.75 score on a scale
Standard Deviation 5.01
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
21.17 score on a scale
Standard Deviation 11.30
|
14.38 score on a scale
Standard Deviation 4.60
|
|
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
20.33 score on a scale
Standard Deviation 9.67
|
12.71 score on a scale
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed
The Dyadic Adjustment Scale is a 32-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 151. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
112.27 score on a scale
Standard Deviation 15.31
|
109.60 score on a scale
Standard Deviation 18.84
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
115.44 score on a scale
Standard Deviation 12.13
|
112.00 score on a scale
Standard Deviation 18.50
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
117.29 score on a scale
Standard Deviation 19.76
|
119.29 score on a scale
Standard Deviation 14.04
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
113.67 score on a scale
Standard Deviation 23.96
|
112.75 score on a scale
Standard Deviation 17.77
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
114.17 score on a scale
Standard Deviation 26.13
|
116.43 score on a scale
Standard Deviation 15.98
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
110.27 score on a scale
Standard Deviation 14.95
|
116.00 score on a scale
Standard Deviation 16.75
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
112.14 score on a scale
Standard Deviation 16.63
|
112.71 score on a scale
Standard Deviation 14.31
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
111.17 score on a scale
Standard Deviation 7.88
|
119.43 score on a scale
Standard Deviation 16.00
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
110.67 score on a scale
Standard Deviation 7.12
|
117.83 score on a scale
Standard Deviation 17.93
|
|
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
112.50 score on a scale
Standard Deviation 9.77
|
114.00 score on a scale
Standard Deviation 21.36
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Dyadic Adjustment Scale-Short Form (DAS-4) is a 4-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 21. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
15.91 score on a scale
Standard Deviation 2.34
|
16.30 score on a scale
Standard Deviation 2.87
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
17.33 score on a scale
Standard Deviation 1.66
|
16.13 score on a scale
Standard Deviation 2.70
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
16.71 score on a scale
Standard Deviation 3.04
|
17.00 score on a scale
Standard Deviation 2.83
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
17.33 score on a scale
Standard Deviation 2.42
|
16.13 score on a scale
Standard Deviation 3.48
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
17.00 score on a scale
Standard Deviation 3.10
|
17.43 score on a scale
Standard Deviation 2.76
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
15.82 score on a scale
Standard Deviation 2.64
|
15.90 score on a scale
Standard Deviation 3.11
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
15.86 score on a scale
Standard Deviation 2.19
|
15.50 score on a scale
Standard Deviation 1.93
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
16.67 score on a scale
Standard Deviation 1.37
|
17.13 score on a scale
Standard Deviation 2.17
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
15.83 score on a scale
Standard Deviation 2.23
|
17.25 score on a scale
Standard Deviation 2.25
|
|
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
16.00 score on a scale
Standard Deviation 2.19
|
17.29 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Communication Patterns Questionnaire-Short Form (modified for Binge-Eating Disorder) assesses how the couple communicates about binge-eating when the issue arises and when discussing the issue. Item responses range from 1 to 9. The three subscales measured are Self Demand/Partner Withdraw (3 items), Partner Demand/Self Withdraw (3 items), and Constructive Communication (3 items). The Demand/Withdraw subscales were combined and have a score range of 6 to 54 and the Constructive Communication subscale has a score range of 3 to 27. Higher (subscale) sum scores indicate more of those types of behaviors, respectively; high scores on the Demand/Withdraw and low scores on the Constructive Communication subscale are worse, respectively.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients, Demand/Withdraw subscale
|
18.55 score on a scale
Standard Deviation 6.65
|
20.70 score on a scale
Standard Deviation 10.94
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients, Demand/Withdraw subscale
|
16.33 score on a scale
Standard Deviation 8.90
|
18.38 score on a scale
Standard Deviation 8.37
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients, Demand/Withdraw subscale
|
18.57 score on a scale
Standard Deviation 9.62
|
15.29 score on a scale
Standard Deviation 11.64
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients, Demand/Withdraw subscale
|
12.50 score on a scale
Standard Deviation 7.61
|
12.88 score on a scale
Standard Deviation 6.83
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients, Demand/Withdraw subscale
|
13.00 score on a scale
Standard Deviation 5.93
|
13.43 score on a scale
Standard Deviation 7.96
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners, Demand/Withdraw subscale
|
18.36 score on a scale
Standard Deviation 8.09
|
14.50 score on a scale
Standard Deviation 8.75
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners, Demand/Withdraw subscale
|
16.57 score on a scale
Standard Deviation 8.32
|
16.50 score on a scale
Standard Deviation 6.57
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners, Demand/Withdraw subscale
|
22.83 score on a scale
Standard Deviation 9.79
|
12.25 score on a scale
Standard Deviation 5.28
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners, Demand/Withdraw subscale
|
14.00 score on a scale
Standard Deviation 9.06
|
14.13 score on a scale
Standard Deviation 6.85
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners, Demand/Withdraw subscale
|
16.33 score on a scale
Standard Deviation 6.28
|
14.71 score on a scale
Standard Deviation 8.40
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients, Constructive Communication subscale
|
18.45 score on a scale
Standard Deviation 6.98
|
16.40 score on a scale
Standard Deviation 4.67
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients, Constructive Communication subscale
|
17.56 score on a scale
Standard Deviation 7.26
|
16.00 score on a scale
Standard Deviation 5.24
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients, Constructive Communication subscale
|
19.86 score on a scale
Standard Deviation 5.84
|
21.86 score on a scale
Standard Deviation 4.22
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients, Constructive Communication subscale
|
18.83 score on a scale
Standard Deviation 9.33
|
20.38 score on a scale
Standard Deviation 4.84
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients, Constructive Communication subscale
|
18.33 score on a scale
Standard Deviation 9.29
|
21.43 score on a scale
Standard Deviation 3.64
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners, Constructive Communication subscale
|
15.18 score on a scale
Standard Deviation 6.03
|
20.20 score on a scale
Standard Deviation 3.97
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners, Constructive Communication subscale
|
19.57 score on a scale
Standard Deviation 4.47
|
20.50 score on a scale
Standard Deviation 3.46
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners, Constructive Communication subscale
|
20.83 score on a scale
Standard Deviation 4.79
|
22.88 score on a scale
Standard Deviation 2.95
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners, Constructive Communication subscale
|
18.17 score on a scale
Standard Deviation 6.40
|
20.75 score on a scale
Standard Deviation 4.23
|
|
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners, Constructive Communication subscale
|
20.33 score on a scale
Standard Deviation 5.28
|
21.86 score on a scale
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
The Eating Disorder Quality of Life questionnaire is a self-report 25-item health-related quality of life questionnaire that measures the perceived extent to which the eating disorder affects the subject's quality of life in different domains. Item responses range from 0 to 4, with a possible score range of 0 to 100. Higher scores indicate lower quality of life.
Outcome measures
| Measure |
CBT-E
n=11 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=10 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
Pre (T0)
|
1.22 score on a scale
Standard Deviation 0.58
|
1.38 score on a scale
Standard Deviation 0.55
|
|
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
Mid-Treatment (T1)
|
0.86 score on a scale
Standard Deviation 0.41
|
1.10 score on a scale
Standard Deviation 0.44
|
|
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
Post (T2)
|
0.86 score on a scale
Standard Deviation 0.45
|
0.73 score on a scale
Standard Deviation 0.36
|
|
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
3 Month Fup (T3)
|
0.63 score on a scale
Standard Deviation 0.51
|
0.52 score on a scale
Standard Deviation 0.43
|
|
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
6 Month Fup (T4)
|
0.45 score on a scale
Standard Deviation 0.65
|
0.51 score on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.
This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study, the investigators examined the Problem-Solving Communication scale (PSC - 19 items), which measures the inability to resolve differences in the relationship. PSC scores range from 0-19 with higher scores indicating poorer problem-solving communication skills.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
9.18 score on a scale
Standard Deviation 6.40
|
6.33 score on a scale
Standard Deviation 5.72
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
5.64 score on a scale
Standard Deviation 4.23
|
7.20 score on a scale
Standard Deviation 5.65
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
6.22 score on a scale
Standard Deviation 4.84
|
8.25 score on a scale
Standard Deviation 5.01
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
6.14 score on a scale
Standard Deviation 4.74
|
6.14 score on a scale
Standard Deviation 5.64
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
6.17 score on a scale
Standard Deviation 4.45
|
7.00 score on a scale
Standard Deviation 5.83
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
6.17 score on a scale
Standard Deviation 5.85
|
6.14 score on a scale
Standard Deviation 3.85
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
7.14 score on a scale
Standard Deviation 5.40
|
7.25 score on a scale
Standard Deviation 6.61
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
8.50 score on a scale
Standard Deviation 5.89
|
5.75 score on a scale
Standard Deviation 5.55
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
10.00 score on a scale
Standard Deviation 5.62
|
6.00 score on a scale
Standard Deviation 5.37
|
|
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
8.50 score on a scale
Standard Deviation 5.21
|
4.00 score on a scale
Standard Deviation 5.33
|
SECONDARY outcome
Timeframe: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)Population: Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.
This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study the investigators examined the 13-item Affective Communication scale (ACS), which assesses general communication. ACS scores range from 0-13 with higher scores indicating poorer affective communication skills.
Outcome measures
| Measure |
CBT-E
n=22 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=20 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Pre (T0) Patients
|
4.09 score on a scale
Standard Deviation 3.36
|
4.30 score on a scale
Standard Deviation 3.71
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Patients
|
3.67 score on a scale
Standard Deviation 3.84
|
5.13 score on a scale
Standard Deviation 4.29
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
3.57 score on a scale
Standard Deviation 4.39
|
2.57 score on a scale
Standard Deviation 1.99
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Patients
|
4.17 score on a scale
Standard Deviation 3.92
|
4.50 score on a scale
Standard Deviation 3.34
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Patients
|
4.33 score on a scale
Standard Deviation 4.80
|
3.14 score on a scale
Standard Deviation 2.48
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Pre (T0) Partners
|
4.36 score on a scale
Standard Deviation 3.20
|
2.50 score on a scale
Standard Deviation 2.14
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Mid-Treatment (T1) Partners
|
4.00 score on a scale
Standard Deviation 3.96
|
2.43 score on a scale
Standard Deviation 2.37
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
3.83 score on a scale
Standard Deviation 4.07
|
2.75 score on a scale
Standard Deviation 3.20
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
3 Month Fup (T3) Partners
|
3.83 score on a scale
Standard Deviation 3.06
|
2.75 score on a scale
Standard Deviation 2.60
|
|
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
6 Month Fup (T4) Partners
|
4.00 score on a scale
Standard Deviation 3.10
|
1.17 score on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Post (after 16 weekly treatment sessions) (T2)Population: Patients in CBT-E and UNITE, and partners in UNITE, completed this measure. CBT-E partners did not complete this measure as they did not receive any treatment. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.
Treatment acceptability was measured with the 8-item Client Satisfaction Questionnaire, a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate greater treatment satisfaction (acceptability). An independent samples t test was conducted.
Outcome measures
| Measure |
CBT-E
n=7 Participants
CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.
|
UNITE
n=15 Participants
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
|
|---|---|---|
|
Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Patients
|
28.71 score on a scale
Standard Deviation 3.64
|
29.24 score on a scale
Standard Deviation 3.55
|
|
Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners
Post (T2) Partners
|
—
|
30.38 score on a scale
Standard Deviation 2.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Pre-treatment through Follow-upCouple communication will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS), observational coding systems that assess communication behaviors, affective expression, and supportive behavior.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Pre-treatment through Follow-upCouple interpersonal problem-solving/behavior change skills will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to problem-solve on some aspect of the patient's binge-eating disorder and attempt to agree upon behavioral changes that they will make. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Pre-treatment through Follow-upTwo 10-minute video-taped interactions during which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder and to problem-solve on some aspect of the patient's binge-eating disorder, respectively. Vocally encoded emotional arousal will be measured using fundamental frequency (f0) from patients' and partners' speech. F0 is a spectral analysis-based measure of speech prosody that refers to the lowest frequency harmonic of the speech sound wave, created by the opening and closing of the vocal folds while air flows outward from the lungs during speech production. Emotion regulation is indicated by one's ability to return to a stable set-point after being perturbed from that set-point. Stronger regulation is indicated by a faster return to the set-point. The range of fundamental frequency for speech in adult men and women is approximately 75-300hz.
Outcome measures
Outcome data not reported
Adverse Events
CBT-E Patients
CBT-E Partners
UNITE Patients
UNITE Partners
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hunna Watson, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place