The purpose of the present pilot study is to evaluate the feasibility, acceptability and likely effectiveness of an evidence-based guided self-help intervention for binge eating and related disordered over-eating in those unable to access clinician provided treatments. If feasible, acceptable and likely to be effective, such interventions could be made available more widely as an early intervention to those in need. Such interventions have the potential to improve quality of life by removing or ameliorating symptoms that impair psychological and social functioning. Eligible participants will receive the guided self-help intervention - an evidence-based self help program in the form of a self-help book plus telephone support and encouragement to follow the program provided by specially trained help-line volunteers. Support completing the self-help program will be provided over a period of 4 months and participants will be followed up for a year after completion of the intervention. Participants will be asked to complete brief online assessments before starting the program, at the end of 4 months when they complete the program and at 6 month and 12 month follow up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
44
Based on evidence based cognitive behavioral treatment for eating disorders. Self-help version described in self-help book. Participant follows self-help program with encouragement and support of a non specialist guide
Yale Medical School Department of Psychiatry
New Haven, Connecticut, United States
Feasibility of providing intervention-consent
Percentage of eligible participants who consent to intervention
Time frame: week 0 (baseline)
Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention
Percentage of eligible participants who complete intervention
Time frame: 16 weeks
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors of strongly agree to strongly disagree
Time frame: At Baseline - before start of intervention
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 16 weeks
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 10 months
Ratings of Acceptability of intervention to participants
Participants' ratings of suitability of intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 16 months
Ratings of participants' satisfaction with intervention with anchors strongly agree to strongly disagree
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 16 weeks
Ratings of participants' satisfaction with intervention
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 10 months
Ratings of participants' satisfaction with intervention
Participants rating of satisfaction with intervention on visual analogue scale with anchors strongly agree to strongly disagree
Time frame: 16 months
Likely effectiveness -Eating difficulties
Change in global score on a well validated self-report measure of eating disorder attitudes and behavior-Eating Disorder Questionnaire. Possible range from 0 - 6 where higher score indicates worse symptoms.
Time frame: week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness -Eating difficulties
Change in global score on a well validated self-report measure of eating disorder attitudes and behavior-Eating Disorder Questionnaire. Possible range from 0 - 6 where higher score indicates worse symptoms.
Time frame: week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - impairment due to eating difficulties
Change in impairment due to eating difficulties score on well validated self report measure the Clinical Impairment assessment (CIA). Possible scores range from 0 (no impairment ) to 48 (highest level of impairment).
Time frame: Week 0 (baseline) and week 16 (end of intervention)
Likely effectiveness - impairment due to eating difficulties
Change in impairment due to eating difficulties score on well validated self report measure the Clinical Impairment assessment (CIA). Possible scores range from 0 (no impairment ) to 48 (highest level of impairment).
Time frame: Week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)
Likely effectiveness - depression
Change in depression scores on well validated self report measure, Patient Health Questionnaire (PHQ 9). Possible scores 0 (no depressed mood) to 27 (highest levels of depressive symptoms.
Time frame: Week 0 and week 16 (end of intervention)
Likely effectiveness - depression
Change in depression scores on well validated self report measure, Patient Health Questionnaire (PHQ 9). Possible scores 0 (no depressed mood) to 27 (highest levels of depressive symptoms.
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Time frame: Week 0 and week 64 (48 weeks/1 Year after end of intervention)