What side effects are associated with this type of intervention?

Common treatments for PTSD include pharmacological options like prazosin and SSRIs/SNRIs, as well as non-pharmacological approaches such as cognitive-behavioral therapy (CBT). Prazosin, an alpha-adrenergic receptor blocker, can cause side effects such as hypotension, dizziness, and rebound hypertension if discontinued abruptly. SSRIs and SNRIs may lead to side effects including nausea, insomnia, sexual dysfunction, and increased anxiety. CBT, a non-pharmacological treatment, generally has fewer side effects but may cause temporary emotional discomfort as patients confront traumatic memories.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), including selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. These medications help manage PTSD symptoms such as anxiety and depression, which can indirectly support weight management by improving overall mental health. Prazosin, an alpha-adrenergic receptor blocker, is also used off-label to treat PTSD-related nightmares and sleep disturbances. While not directly approved for weight management, these treatments can help alleviate PTSD symptoms that may interfere with weight loss efforts, aligning with the goals of integrated programs like MOVE!+UP.

What other types of research exist?

Promising, novel alternatives to the Tailored Weight Management Program for PTSD patients include: 1) Cognitive-behavioral therapy (CBT) combined with physical exercise and dietary therapy, which has shown feasibility and effectiveness in treating eating disorders and improving psychological health. 2) Service dog training programs, which have demonstrated benefits in PTSD symptom management and could complement weight management efforts. 3) Pharmacotherapy options such as lisdexamfetamine, which has been effective in treating binge-eating disorder and could help manage weight and PTSD symptoms. These alternatives offer a comprehensive approach by addressing both mental and physical health needs.

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Tailored Weight Management Program for Veterans with PTSD

N/A

Waitlist Available

Led By Katherine D Hoerster, PhD MPH BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline weight >440 lbs

or moderate to severe chronic, progressive neurologic conditions such as Dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 and 12 months post-baseline

Awards & highlights

Summary

This trial tests a new weight loss program, MOVE!+UP, for Veterans with PTSD who are overweight. The program combines weight loss support with therapy to address PTSD-related challenges. It aims to improve both weight and PTSD symptoms. MOVE!+UP is a tailored weight management program developed to address the unique barriers faced by veterans with PTSD, combining weight loss education with cognitive behavior therapy skills.

Who is the study for?

This trial is for Veterans with PTSD who are overweight or obese, have experienced trauma, and score at least 33 on the PCL-5. They must be enrolled in PTSD treatment, approved by a physician to participate, and not planning bariatric surgery soon. Excluded are those with severe hearing loss, no phone access, current MOVE! participation or pregnancy.

What is being tested?

The study tests a tailored weight management program called MOVE!+UP against the standard VA care program MOVE!. It aims to see if addressing PTSD-related barriers within the weight management program can improve both weight and PTSD symptoms more effectively than standard care.

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medication, typical side effects associated with drugs may not apply. However, participants might experience stress or discomfort related to changes in diet and exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is over 440 lbs.

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I have a moderate to severe long-term brain condition like dementia.

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I have had or plan to have weight loss surgery within 18 months.

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I cannot safely use a scale due to mobility issues or because I use assistive devices.

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I have PTSD with a trauma history and a score of 33 or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 and 12 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 and 12 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 and 12 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

weight (pounds) change

Secondary study objectives

PTSD symptom severity on the PTSD Checklist for DSM-5

weight (pounds)

Other study objectives

Eating habits measured with "PACE" eating habits measure

Internalized weight bias measured with "Modified Weight Bias Internalization Scale"

binge eating disorder criteria (yes vs. no) measured using an adapted Patient Health Questionnaire for DSM 5 criteria

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MOVE!+UP (intervention)Experimental Treatment1 Intervention

usual care enhanced with MOVE!+UP (intervention)

Group II: MOVE! (control condition)Active Control1 Intervention

usual care enhanced with MOVE! (control condition)

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD include cognitive-behavioral therapy (CBT), exposure therapy, and integrated approaches that address comorbid conditions like substance use disorders. CBT helps patients reframe negative thought patterns and develop coping strategies. Exposure therapy involves controlled exposure to trauma-related memories to reduce their emotional impact. Integrated approaches, such as Seeking Safety, focus on both PTSD and related issues like substance abuse, emphasizing safety and grounding techniques. These treatments are crucial for PTSD patients as they not only alleviate PTSD symptoms but also address barriers to healthy behaviors, such as weight management, by improving overall psychological functioning and reducing avoidance behaviors.

Theoretical and empirical issues in the treatment of post-traumatic stress disorder in Vietnam veterans.Providing a treatment rationale for PTSD: does what we say matter?