Analysis of binary outcomes with missing data: missing = smoking, last observation carried forward, and a little multiple imputation.
Donald Hedeker, Robin J Mermelstein, Hakan Demirtas
https://pubmed.ncbi.nlm.nih.gov/17854333/Actively Recruiting
Led by VA Connecticut Healthcare System · Updated on 2025-11-25
144
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying ways to improve access to evidence-based treatments for eating disorders, specifically Bulimia Nervosa and Binge Eating Disorder, among active duty Service members and Veterans. This trial compares two types of cognitive behavioral therapy CBT delivered virtually or as self-help, aiming to reduce binge eating frequency and improve mental health outcomes. The study also seeks to inform VA Clinical Practice Guidelines to better serve diverse and underrepresented populations affected by eating disorders. Participants will be randomly assigned to one of two groups Telehealth Cognitive Behavioral Therapy TeleCBT or Self-Help Cognitive Behavioral Therapy shCBT. TeleCBT involves 8 to 10 individual sessions conducted by a masters-level clinician over three months using an approved video platform. The shCBT group will receive the same treatment materials by mail and complete one chapter per week independently over 12 weeks. Both treatments use the same CBT manual adapted for Veterans. During the study, participants will have assessments at baseline, 3 months post-treatment, and 6 months to measure changes in binge frequency using interviews and questionnaires. Additional evaluations will track depression, PTSD symptoms, overall wellness, and participant engagement and satisfaction. Researchers will monitor progress via surveys and clinical interviews to understand treatment effects and support future implementation. The total participation duration spans at least six months, including follow-up evaluations.
CONDITIONS
Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans
R
Robin M Masheb, PhD
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VA Connecticut Healthcare System
Lead Sponsor
United States Department of Defense
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Telehealth Therapist-Led CBT | Self-Help CBT (Guided Manual) |
|---|---|---|
| What it is | A structured therapist-led Cognitive Behavioral Therapy program delivered via telehealth, following a manualized three-stage CBT protocol adapted for veterans with binge-eating disorder or bulimia. | A self-directed Cognitive Behavioral Therapy program using written materials and minimal therapist support, also following the same three-stage CBT manual for veterans with binge-eating disorder or bulimia. |
| Role in the study | Serves as the experimental intervention arm to test whether therapist-led telehealth CBT improves binge-eating or bulimia symptoms in veterans compared to self-directed treatment. | Acts as the active comparator arm, offering participants access to the same CBT content in a self-guided written format. |
| Primary use | To reduce episodes of binge eating or bulimia and support long-term recovery in adults with these disorders who use VA healthcare, by providing structured, therapist-supported therapy remotely. | To reduce symptoms of binge eating or bulimia by providing accessible, self-guided CBT tools and resources to veterans, aiming to empower participants in their own recovery. |
| How it is given or performed | Participants connect remotely with a trained therapist, who guides them through three stages of CBT over scheduled telehealth sessions, following an adapted protocol for veterans. | Participants work independently through the CBT manual at their own pace. Minimal therapist input is provided as required; primary work is participant-driven. |
| Evidence status | Therapist-led CBT is supported by multiple meta-analyses and systematic reviews as an effective treatment for both binge-eating disorder and bulimia, including in remote and veteran populations, though evidence on telehealth delivery is emerging. | Self-help CBT approaches also show benefit for some adults with binge-eating disorder and bulimia, but typically achieve lower abstinence rates and less sustained improvement compared to therapist-led CBT. |
| Important limitations | Requires reliable access to telehealth technology and regular sessions with a therapist, which may not be feasible for all participants. Individual adaptation for unique needs or comorbidities may be limited in protocol-led settings. | May be less effective for individuals needing structured session accountability, and lower engagement can affect treatment completion and outcomes. Some veterans may require greater support than self-help provides. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive Cognitive Behavioral Therapy (CBT) either through Telehealth sessions or self-help materials to reduce binge eating behaviors.
8 to 10 hourly sessions for TeleCBT or weekly self-help chapters for shCBT
Duration - 3 months
Participants are monitored after treatment to assess ongoing changes in eating behavior and mental health outcomes.
Assessments at 3 and 6 months post-baseline
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23815116/VA Connecticut Healthcare System
Lead Sponsor
United States Department of Defense
Collaborating Sponsor