Anorexia Nervosa
Conditions
Keywords
FBT, Family Based Treatment, Guided Self-Help
Brief summary
This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data collected in a previous study suggest that a Guided Parental Self-Help Version of FBT (GSH-FBT) has similar outcomes as therapist provided FBT.
Detailed description
In this study, families will be randomized to either receive 12 weekly online sessions of Guided Self-Help for Family Based Treatment (GSH-FBT), or 15 sessions of online, professionally delivered, standard FBT over the course of 6 months. Potential subjects will be recruited from Stanford University, McMaster University, other local medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview during which the investigators will conduct interviews and collect questionnaire measures. Participants will complete a follow-up interview at the end of treatment and 3-month after end of treatment.
Interventions
BEHAVIORALGuided Self-Help for Family Based Treatment
A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
BEHAVIORALFamily Based Treatment
Standard Family Based Treatment provided for up to 15 sessions.
Sponsors
McMaster University
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Participants are 12-18 years of age 2. Participants live with a family (some families may contain only one parent) 3. Family members fluently speak and read English and have access to a computer with internet 4. Participants meet DSM-5 criteria for AN (both subtypes) 5. IBW between 75% and 88% 6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine 7. Participants are not engaged in another individual or family based psychotherapy trial during the duration of treatment sessions in the study. 8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.
Exclusion criteria
1. Associated physical illness that necessitates hospitalization 2. Psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy. 3. Current dependence on drugs or alcohol 4. Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight 5. Previous (5 or more sessions of) or current FBT-AN 6. Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments. 7. Current weight is less than 75% or above 88% of expected weight given age and height.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Assessed through the end of recruitment (about one year) | Number of participants enrolled in the study per month. |
| Treatment Retention Rate | Up to 6 months | The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT). |
| Study Retention Rate | Up to 9 months | The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment. |
| Treatment Acceptability Ratings | Session 1 and Session 8 (approximately 5 minutes to complete questionnaire) | To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from Strongly feels it's true (+3) to Strongly feel it's not true (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded. |
| Number of Treatment Sessions Attended | Through end of treatment (up to approximately 6 months) | The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted. |
| Serious Adverse Events | Baseline through end of treatment period (up to 6 months) | Number of events in which a participant required hospitalization |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FBT-V Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions. | 20 |
| GSH-FBT Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.
Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.93 years STANDARD_DEVIATION 1.82 | 14.82 years STANDARD_DEVIATION 1.86 | 14.88 years STANDARD_DEVIATION 1.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 18 Participants | 35 Participants |
| Region of Enrollment Canada | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United States | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 4 / 20 |
Outcome results
Primary
Number of Treatment Sessions Attended
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
Time frame: Through end of treatment (up to approximately 6 months)
Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Sample | Number of Treatment Sessions Attended | 13.32 Sessions attended per participant | Standard Deviation 3.32 |
| GSH-FBT | Number of Treatment Sessions Attended | 11.71 Sessions attended per participant | Standard Deviation 0.77 |
Primary
Recruitment Rate
Number of participants enrolled in the study per month.
Time frame: Assessed through the end of recruitment (about one year)
Population: Since this is a feasibility study, all enrolled and randomized participants are analyzed together to report the rate that they were recruited to the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Sample | Recruitment Rate | 2.86 participants recruited per month |
Primary
Serious Adverse Events
Number of events in which a participant required hospitalization
Time frame: Baseline through end of treatment period (up to 6 months)
Population: Following intent-to-treat principles, the number analyzed is based on the total N per sample in each arm, except for investigator withdrawals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Sample | Serious Adverse Events | 2 events |
| GSH-FBT | Serious Adverse Events | 4 events |
Primary
Study Retention Rate
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
Time frame: Up to 9 months
Population: Since this is a feasibility study, participants enrolled and randomized to a treatment arm are analyzed together to report the study retention rate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Sample | Study Retention Rate | 37 Participants |
Primary
Treatment Acceptability Ratings
To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from Strongly feels it's true (+3) to Strongly feel it's not true (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded.
Time frame: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Sample | Treatment Acceptability Ratings | HAQ - Helpfulness after Session 1 | 3.97 score on a scale | Standard Deviation 3.64 |
| Overall Sample | Treatment Acceptability Ratings | HAQ - Helpfulness after Session 8 | 6.01 score on a scale | Standard Deviation 4.36 |
| Overall Sample | Treatment Acceptability Ratings | HAQ - Cooperation after Session 1 | 11.47 score on a scale | Standard Deviation 3.3 |
| Overall Sample | Treatment Acceptability Ratings | HAQ - Cooperation after Session 8 | 13.09 score on a scale | Standard Deviation 3.68 |
| GSH-FBT | Treatment Acceptability Ratings | HAQ - Cooperation after Session 8 | 12.38 score on a scale | Standard Deviation 4.8 |
| GSH-FBT | Treatment Acceptability Ratings | HAQ - Helpfulness after Session 1 | 4.78 score on a scale | Standard Deviation 4.75 |
| GSH-FBT | Treatment Acceptability Ratings | HAQ - Cooperation after Session 1 | 11.91 score on a scale | Standard Deviation 5.74 |
| GSH-FBT | Treatment Acceptability Ratings | HAQ - Helpfulness after Session 8 | 7.77 score on a scale | Standard Deviation 4.4 |
Primary
Treatment Acceptability Ratings
To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome.
Time frame: Session 1 (approximately 5 minutes to complete questionnaire)
Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Sample | Treatment Acceptability Ratings | TSPE - Expectations of Therapy after Session 1 | 8.29 score on a scale | Standard Deviation 1.29 |
| Overall Sample | Treatment Acceptability Ratings | TSPE - Suitability of Treatment after Session 1 | 8.5 score on a scale | Standard Deviation 1.37 |
| GSH-FBT | Treatment Acceptability Ratings | TSPE - Suitability of Treatment after Session 1 | 7.85 score on a scale | Standard Deviation 1.98 |
| GSH-FBT | Treatment Acceptability Ratings | TSPE - Expectations of Therapy after Session 1 | 7.35 score on a scale | Standard Deviation 1.77 |
Primary
Treatment Retention Rate
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Time frame: Up to 6 months
Population: Since this is a feasibility study, all participants who were enrolled and randomized to a treatment arm are analyzed together to report the treatment retention rate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Sample | Treatment Retention Rate | 35 Participants |