Patient choice in treatment of PTSD might boost adherence.
"Our results highlight a need to rethink a 'one size fits all' approach to the treatment of PTSD," Norah C. Feeny, Ph.D., said during a late-breaking research session at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.
"We are fortunate we have good, efficacious treatments for PTSD," Dr. Feeny said. "But patient preference may affect efficacy down the line."
In this first head-to-head comparison between a validated cognitive-behavioral therapy and a selective serotonin reuptake inhibitor for PTSD, 61 % of 200 participants at baseline said they would prefer prolonged exposure. The remaining 39% indicated they would prefer treatment with sertraline.
Dr. Feeny was somewhat surprised by these percentages because "prolonged exposure requires them to engage with material they want to avoid, such as combat, a motor vehicle accident, or sexual assault. Sertraline does not require engagement with this painful stimuli," said Dr. Feeny, director of the PTSD Treatment & Research Program at Case Western Reserve University, Cleveland. The NIMH and Pfizer, maker of Zoloft, funded the study. Zoloft is the brand name for sertraline.
A total of 97 participants were randomized to a "choice" group and 103 others to a "no choice" group. Therefore, some in the no-choice group received an intervention they did not want. This design allowed analysis of the degree to which patient preference affects treatment adherence and outcomes, Dr. Feeny said.
The prolonged exposure group received manualized therapy for 10 weekly sessions, each lasting 90-120 minutes. The sertraline group also received 10 weekly, 30-minute manualized education sessions (e.g., about common reactions to trauma).
"We know very little about how prolonged exposure and sertraline compare with each other," Dr. Feeny said. Although overall there were no significant differences in treatment response (75% in the prolonged exposure group vs. 65% in the sertraline group), "prolonged exposure may have a slight advantage in terms of the magnitude of change [from baseline]."
Patient preference for treatment, however, did make a difference, Dr. Feeny said. After 10 weeks, "those who received their choice were doing better in terms of responder status."
Participants in the no-choice group randomized to the intervention they did not want, referred to as the "discrepancy" cohort, were more likely to have a lower response. "People in the discrepancy group were doing worse on every index." For example, this group had lower adherence to their treatment--they were more likely to attend fewer sessions of prolonged exposure or took "substantially lower" doses of sertraline during the study.
All participants met DSM-IV criteria for chronic PTSD as their primary diagnosis and were aged 18-65 years (mean, 37 years). The cohort was primarily female, 76%. Most, 65%, were white, 22% were African American, and the remaining 13% identified with other ethnic groups. Participants were "quite chronic," enrolling in the study a mean of 12 years after their trauma. The most common traumatic events were adult sexual assault (31%), childhood assault (24%), and adult nonsexual assault (23%). If patients were multiply traumatized, they were asked to choose a primary trauma in case they chose or were assigned to prolonged exposure.
Although patients could not be blinded in this or any behavioral versus medication protocol, raters were blinded to group assignment when interpreting the findings, Dr. Feeny said in response to a meeting attendee question. "In an attempt to be real-world, we were less concerned about blinding people to the interventions."
Dr. Feeny explained why she and her colleagues chose a novel, double-randomized treatment preference study design. Beyond the obvious lack of choice for patients in traditional randomized controlled trial, "if we just let people choose their own medications, there could be selection bias," she said. In an attempt to be as impartial as possible while allowing participants to make a more informed choice, they initially watched two videos. Each video featured clinicians who explained the rationale for each intervention, including efficacy information, procedures, and possible side effects. Wording of the two videos was matched as closely as possible.
Dr. Feeny only presented preliminary, intent-to-treat results of the 10-week Acute Treatment for Chronic PTSD study at the meeting. Two-year follow-up findings will be presented in the future, she added.
Dr. Feeny is a consultant or lecturer for multiple pharmaceutical companies, but none of her disclosures were relevant to this presentation.
Major Finding: Treatment response was 75% in the prolonged exposure group vs. 65% in the sertraline group, which was not a significant difference. However, prolonged exposure might have a slight advantage.
Data Source: Preliminary, intent-to-treat results for 200 participants in the 10-week Acute Treatment for Chronic PTSD study.
Disclosures: Dr. Feeny said she did not have any relevant disclosures.
FROM THE NEW CLINICAL DRUG EVALUATION UNIT MEETING SPONSORED BY THE NATIONAL INSTITUTE OF MENTAL HEALTH
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|Publication:||Clinical Psychiatry News|
|Date:||Jul 1, 2010|
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