آموزش بیماران برای خودتزریقی: بررسی آزمایشی برای درمان اضطراب و هراس از تزریق در بیماران مولتیپل اسکلروزیس تجویز داروهای تزریقی

Medications are increasingly being developed for chronic illnesses that require regular injection. Usually it is recommended that, if possible, patients learn to inject themselves. Self-injection is associated with better adherence than injection by family or clinics. Yet large numbers of people have difficulty learning to self-inject due to injection anxiety or phobia. We present data from eight patients who went through a manualized 6-week cognitive behavioral treatment designed to increase self-efficacy and reduce anxiety. These patients were diagnosed with multiple sclerosis, were prescribed weekly intramuscular interferon beta-1a injections, and were unable to self-inject due to anxiety or phobia. Seven of the eight patients were able to inject within the 6 weeks of therapy. The eighth patient self-injected during an additional seventh session. Seven of the eight patients continued to self-inject at 3-month follow-up. Patients showed significant improvements in self-injection self-efficacy and injection anxiety.

Medications are increasingly being developed for chronic illnesses that require regular injection. Some of the many medical problems that now have treatments requiring regular injection include multiple sclerosis (MS) (Jacobs et al., 1996; Johnson et al., 1995; The IFNB Multiple Sclerosis Study Group, 1993), diabetes (Glasgow, McCaul, & Schafer, 1986; Johnson, 1992), migraine headache (Schulman et al., 2000), allergy (Hurst, Gordon, Fornadley, & Hunsaker, 1999), erectile dysfunction (Manecke & Mulhall, 1999), impaired female fertility (Gocial, Keye, Fein, & Nardi, 2000), and chronic infection (Esposito, 2000). When the medication regimen requires regular or frequent injection, it is preferable to have patients learn to self-inject (Pfohl, 1997). This avoids unnecessary dependence on others or the need for frequent clinic visits to receive medications on schedule. A recent study examined MS patients initiating treatment with interferon beta-1a (IFNβ-1a), which is a disease-modifying medication that requires weekly intramuscular injection (Mohr, Boudewyn, Likosky, Levine, & Goodkin, 2001). Inability to self-inject was significantly related to discontinuation of medication during the first 6 months of treatment. Injection anxiety and phobia are substantial problems for a large number of patients with MS. A specific phobia is diagnosed when a patient reports intense fear and avoidance of a non-dangerous stimulus, and when this fear and avoidance interferes significantly with the patient's normal routine, relationships, or causes marked distress (American Psychiatric Association, 1994). The prevalence of injection phobia has been estimated to be between 7% and 22% in the general population (Agras, Sylvester, & Oliveau, 1969; Bienvenu & Eaton, 1998; Cartwright et al., 1993; Costello, 1982). However, while these studies varied in the sample and criteria used, they all examined avoidance in receiving injections. Prevalence rates of injection-related anxiety significant enough to prevent self-injection may be as high as 50% for some types of injections (Mohr et al., 2001). Understanding predictors of ability to self-inject can suggest potentially useful interventions. Pretreatment self-efficacy expectations regarding ability to self-inject predicted both ability to self-inject and adherence. Self-efficacy refers to the belief in one's capacity to organize and execute specific behaviors to achieve specific goals. It has been found to be central to many health-related behaviors (Bandura, 1997). Injection anxiety after the initiation of treatment was also a significant contributor to adherence (Mohr et al., 2001). These findings suggest that by increasing injection self-efficacy and reducing injection anxiety, patients who initially present with self-injection anxiety may be able to learn to self-inject and increase their adherence to necessary medications. Treatment of injection phobia with the aim of helping patients receive injections has been shown to be effective in both case studies (Fazio, 1970; Ferguson, Taylor, & Wermuth, 1978; Thompson, 1999) and small studies (Oest, Hellstroem, & Kaver, 1992). However, it is likely more difficult for patients to perform self-injection than to receive injection. A few case studies have suggested that patients with injection anxiety or phobia can be taught to self-inject (Ellinwood & Hamilton, 1991; Jacobsen, 1991; Trijsburg et al., 1996). While such case studies are technically informative, they give no indication of how generalizable such an intervention is, since it is unclear how participants are selected. This is the first small study using a clearly articulated sampling procedure to examine a well-defined brief cognitive-behavioral intervention. This intervention was administered in a uniform fashion to assist MS patients with injection anxiety and phobia in learning to self-inject IFNβ-1a. Multiple Sclerosis (MS) is a chronic neurological disease affecting approximately 350,000 people in the United States (Anderson et al., 1992). Since 1993, three disease-modifying treatments have been approved by the FDA to treat relapsing-remitting MS: interferon beta-1b (IFNβ-1b) (The IFNB Multiple Sclerosis Study Group, 1993), interferon beta-1a (IFNβ-1a) (Jacobs et al., 1996), and glatiramer acetate (Johnson et al., 1995). These medications vary in the frequency and method of injection. We focused on IFNβ-1a, an intramuscular injection administered weekly, to reduce medication-related variability and to build on the previous work cited above (Mohr et al., 2001). We hypothesized that a brief cognitive-behavioral intervention would help patients with injection anxiety and phobias learn to self-inject.

Patient characteristics: The study was advertised through the UCSF MS Center and the newsletter of the local chapter of the National MS Society. Of the 20 people screened during the two week enrollment period, five patients were excluded because they were able to self-inject, albeit with anxiety, two were taking IFNβ-1b rather than IFNβ-1a (which requires subcutaneous rather than intramuscular injections), 1 was unable to come into the clinic due to exacerbation, two met criteria for dementia, and two decided not to come to the clinic. The 8 patients who met criteria and were enrolled in the study were female (N=8) with a mean age of 38.2 years (range 29–45). Six were Caucasian, one was Asian/Caucasian, and one was Hispanic/Caucasian. Patients had a mean of 17.0 years of education (range 12–20), six were employed, one was a student, and one was not employed. Six were living with a partner or spouse, while two were not. Four patients met DSM-IV criteria for Specific Phobia, Blood-Injection Type. Two of these patients had other co-morbid specific phobias, and 1 had a history of vasovagal response following injections and self-injection attempts. Seven patients were receiving injections from their spouse, partner, or family member, while one patient came to the UCSF MS Center to receive her injections. Six patients had never been able to self-inject, while two had been able to self-inject at one point but had subsequently developed anxiety that prevented them from self-injecting. Primary outcome: Seven out of eight patients (87.5%) successfully self-injected during the six sessions of treatment. The eighth patient wished to continue treatment until she was able to self-inject, and she self-injected in the seventh session. At 3-month follow-ups, seven of eight continue to self-inject. The non-self-injector at follow-up was not the non-injector at post-treatment. She reported that she chose to have her husband administer the injections, but that she still is able to self-inject, although this was not verified through behavioral assessment. For purposes of statistical analysis, we conservatively determined that seven out of eight patients met criteria for significant improvement at post-treatment and seven out of eight at 3-month follow-up. Thus, this intervention resulted in a significant change in ability to self-injection (Cochran's Q=12.25, p=0.0081). (1) Secondary outcomes: It should be noted that one of the eight enrolled patients successfully injected after the first session and decided not to return. Therefore, for this patient, secondary outcomes were missing at post-treatment but were available for 3-month follow-up. Missing post-treatment data were replaced with baseline data. This is the most conservative method of addressing missing data, as it assumes no change. Results were also run using missing data, which eliminates this subject. The results were not different from those presented. (2) Self-efficacy: The overall MSSE score did not change over time (p=0.11). Self-injection self-efficacy increased significantly over time [F(2,12)=18.15, p<0.001]. Post-hoc Newman Kuels analysis test revealed significant reductions from baseline to post-treatment (p=0.0002), but no significant change between post-treatment and follow-up (p=0.64). (3) Injection anxiety: Participants demonstrated significant reductions in self-injection-related anxiety from pretest to follow-up, as assessed by the SUDS rating, F(2,12)=8.89, p=0.004. Post-hoc analysis with the Newman–Kuels test revealed a significant change between baseline and post-treatment (p=0.009), but no significant change between post-treatment and three-month follow-up (p=0.37).