Trial Outcomes & Findings for Multi-Family Group Therapy for Adult Eating Disorders (NCT NCT02106728)
NCT ID: NCT02106728
Last Updated: 2016-08-29
Results Overview
3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
3 months post enrollment
Results posted on
2016-08-29
Participant Flow
Consecutive patients with Anorexia Nervosa admitted to the Eating Disorder Program between 2011 and 2014, were approached to participate within the first 3 weeks of treatment. Patients shared information about the study with their family members whom they identified as being involved in supporting them.Exclusion factors was current family violence.
Participants were assigned non-randomly to Separated Family Therapy (treatment as usual) or Multi-Family thearpy dependent on treatment availability. MFT was offered four times a year as a closed group. A series of groups would begin once four to six families consented to participate in the study. After a group started, families were offered SFT.
Participant milestones
| Measure |
Multi-Family Therapy
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
47
|
|
Overall Study
COMPLETED
|
70
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Family Group Therapy for Adult Eating Disorders
Baseline characteristics by cohort
| Measure |
Multi-Family Therapy
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.20 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
26.20 years
STANDARD_DEVIATION 7.36 • n=7 Participants
|
26.20 years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
70 participants
n=5 Participants
|
47 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Diagnosis of Patient Participant Subset
Anorexia Nervosa (Restrictive Subtype)
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Diagnosis of Patient Participant Subset
(Anorexia Nervosa (Binge Purge subtype)
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post enrollment3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)
Outcome measures
| Measure |
Multi-Family Therapy
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (POST)
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (POST)
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (8WEEKS)
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (Approximately 10 WEEKS)
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
|---|---|---|---|---|---|---|
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Dropout
|
17 participants
|
18 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)Change in weight is measured to gauge if there has been a loss, gain, or maintenance.
Outcome measures
| Measure |
Multi-Family Therapy
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (POST)
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (POST)
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (8WEEKS)
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (Approximately 10 WEEKS)
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
|---|---|---|---|---|---|---|
|
Change in Weight
Post-Treatment Weight
|
20.29 pounds
Standard Deviation 1.41
|
20.29 pounds
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Change in Weight
Pre-Treatment Weight
|
15.68 pounds
Standard Deviation 1.61
|
15.68 pounds
Standard Deviation 1.61
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatmentEDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer's families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression
Outcome measures
| Measure |
Multi-Family Therapy
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (POST)
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (POST)
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
|
Multi-Family Therapy (8WEEKS)
n=70 Participants
Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.
Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
|
Supportive Family Therapy (Approximately 10 WEEKS)
n=47 Participants
Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.
Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
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|---|---|---|---|---|---|---|
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Change in Caregiver Functioning
Eating Disorder Symptom Impact Scale_behaviour
|
4.57 units on a scale
Standard Deviation 4.56
|
3.31 units on a scale
Standard Deviation 3.55
|
2.41 units on a scale
Standard Deviation 2.69
|
.95 units on a scale
Standard Deviation 1.38
|
2.03 units on a scale
Standard Deviation 2.66
|
1.57 units on a scale
Standard Deviation 1.63
|
|
Change in Caregiver Functioning
Eating Disorder Symptom Impact Scale_overall
|
35.13 units on a scale
Standard Deviation 15.11
|
35.06 units on a scale
Standard Deviation 11.58
|
22.28 units on a scale
Standard Deviation 14.70
|
18.18 units on a scale
Standard Deviation 1.06
|
18.21 units on a scale
Standard Deviation 13.26
|
13.94 units on a scale
Standard Deviation 3.76
|
|
Change in Caregiver Functioning
Eating Disorder Symptom Impact Scale_guilt
|
10.12 units on a scale
Standard Deviation 5.24
|
8.64 units on a scale
Standard Deviation 3.92
|
6.67 units on a scale
Standard Deviation 4.99
|
5.49 units on a scale
Standard Deviation 3.92
|
6.11 units on a scale
Standard Deviation 4.73
|
3.76 units on a scale
Standard Deviation 2.58
|
|
Change in Caregiver Functioning
Eating Disorder Symptom Impact Sc_social isolation
|
4.62 units on a scale
Standard Deviation 3.49
|
5.13 units on a scale
Standard Deviation 3.05
|
3.64 units on a scale
Standard Deviation 3.84
|
3.32 units on a scale
Standard Deviation 3.15
|
3.17 units on a scale
Standard Deviation 2.69
|
2.20 units on a scale
Standard Deviation 2.34
|
|
Change in Caregiver Functioning
Social Provisions Scale_reassurance of worth
|
13.02 units on a scale
Standard Deviation 2.07
|
13.29 units on a scale
Standard Deviation 1.60
|
13.47 units on a scale
Standard Deviation 1.75
|
13.13 units on a scale
Standard Deviation 1.26
|
13.32 units on a scale
Standard Deviation 1.88
|
12.82 units on a scale
Standard Deviation 1.18
|
|
Change in Caregiver Functioning
Social Provisions Scale_guidance
|
12.76 units on a scale
Standard Deviation 1390
|
13.34 units on a scale
Standard Deviation 1.90
|
13.41 units on a scale
Standard Deviation 1.75
|
13.21 units on a scale
Standard Deviation 1.79
|
12.98 units on a scale
Standard Deviation 1.94
|
12.84 units on a scale
Standard Deviation 1.48
|
|
Change in Caregiver Functioning
Social Provisions Scale_nurturance
|
12.55 units on a scale
Standard Deviation 2.46
|
11.69 units on a scale
Standard Deviation 2.67
|
12.58 units on a scale
Standard Deviation 2.01
|
11.95 units on a scale
Standard Deviation 2.08
|
12.49 units on a scale
Standard Deviation 2.48
|
11.83 units on a scale
Standard Deviation 1.51
|
|
Change in Caregiver Functioning
Social Provisions Scale_reliance alliance
|
14.18 units on a scale
Standard Deviation 1.56
|
13.14 units on a scale
Standard Deviation 1.77
|
13.68 units on a scale
Standard Deviation 1.37
|
13.20 units on a scale
Standard Deviation 1.83
|
13.53 units on a scale
Standard Deviation 1.56
|
12.93 units on a scale
Standard Deviation 1.64
|
|
Change in Caregiver Functioning
DCCFS_consumer
|
15.93 units on a scale
Standard Deviation 3.14
|
14.94 units on a scale
Standard Deviation 3.30
|
15.64 units on a scale
Standard Deviation 3.02
|
15.46 units on a scale
Standard Deviation 2.89
|
15.33 units on a scale
Standard Deviation 2.49
|
14.99 units on a scale
Standard Deviation 2.06
|
|
Change in Caregiver Functioning
DCCFS_family
|
14.25 units on a scale
Standard Deviation 3.87
|
13.41 units on a scale
Standard Deviation 2.62
|
14.84 units on a scale
Standard Deviation 2.57
|
13.38 units on a scale
Standard Deviation 2.65
|
14.05 units on a scale
Standard Deviation 3.32
|
14.04 units on a scale
Standard Deviation 1.97
|
|
Change in Caregiver Functioning
Beck Depression Inventory
|
12.64 units on a scale
Standard Deviation 9.75
|
10.50 units on a scale
Standard Deviation 7.54
|
8.68 units on a scale
Standard Deviation 9.92
|
7.52 units on a scale
Standard Deviation 7.52
|
6.12 units on a scale
Standard Deviation 8.34
|
3.77 units on a scale
Standard Deviation 2.72
|
|
Change in Caregiver Functioning
Eating Disorder Symptom Impact Scale_nutrition
|
15.69 units on a scale
Standard Deviation 6.13
|
18.04 units on a scale
Standard Deviation 5.62
|
9.43 units on a scale
Standard Deviation 6.47
|
8.41 units on a scale
Standard Deviation 6.10
|
6.98 units on a scale
Standard Deviation 5.21
|
6.81 units on a scale
Standard Deviation 3.81
|
|
Change in Caregiver Functioning
Family Questionnaire_criticism
|
19.92 units on a scale
Standard Deviation 4.73
|
16.80 units on a scale
Standard Deviation 6.20
|
16.46 units on a scale
Standard Deviation 4.69
|
15.08 units on a scale
Standard Deviation 4.25
|
16.38 units on a scale
Standard Deviation 4.18
|
12.91 units on a scale
Standard Deviation 2.21
|
|
Change in Caregiver Functioning
Family Questionnaire_over-involvement
|
26.17 units on a scale
Standard Deviation 4.40
|
27.06 units on a scale
Standard Deviation 4.28
|
23.97 units on a scale
Standard Deviation 5.20
|
24.23 units on a scale
Standard Deviation 4.37
|
21.82 units on a scale
Standard Deviation 5.42
|
19.52 units on a scale
Standard Deviation 3.30
|
|
Change in Caregiver Functioning
Social Provisions Scale_overall
|
76.47 units on a scale
Standard Deviation 9.41
|
78.22 units on a scale
Standard Deviation 7.07
|
78.40 units on a scale
Standard Deviation 8.77
|
77.41 units on a scale
Standard Deviation 6.27
|
77.07 units on a scale
Standard Deviation 86.17
|
75.77 units on a scale
Standard Deviation 5.10
|
|
Change in Caregiver Functioning
Social Provisions Scale_attachment
|
12.31 units on a scale
Standard Deviation 2.49
|
12.18 units on a scale
Standard Deviation 2.09
|
12.79 units on a scale
Standard Deviation 2.45
|
12.59 units on a scale
Standard Deviation 1.55
|
12.32 units on a scale
Standard Deviation 23.70
|
12.07 units on a scale
Standard Deviation 1.68
|
|
Change in Caregiver Functioning
Social Provisions Scale_social integration
|
12.69 units on a scale
Standard Deviation 2.09
|
13.10 units on a scale
Standard Deviation 1.57
|
12.78 units on a scale
Standard Deviation 1.90
|
12.89 units on a scale
Standard Deviation 1.51
|
12.98 units on a scale
Standard Deviation 1.64
|
12.74 units on a scale
Standard Deviation 1.37
|
Adverse Events
Multi-Family Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Family Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place