Preliminary Findings Study design

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A single large trial of IPSRT as a treatment for bipolar disorder (in combination with medication) is currently nearing completion at the University of Pittsburgh. This study, Maintenance Therapies in Bipolar Disorder (MTBD), is funded by a grant from the National Institute of Mental Health (R37 MH29618). In MTBD, acutely ill patients meeting criteria for bipolar I disorder are treated with medication and randomly assigned to either IPSRT or intensive clinical management (ICM). In order to enter the protocol, subjects must meet the Schedule for Affective Disorders and Schizophrenia criteria (Spitzer & Endicott, 1978) or the Research Diagnostic Criteria (Endicott et al., 1977) for bipolar I disorder with a score of 15 or greater on the 24-item HRSD (Hamilton, 1960; Thase et al., 1991) or the Bech-Rafaelson Mania Scale (Bech et al., 1979). Exclusion criteria include pregnancy, chronic alcohol and drug abuse, rapid cycling (defined as four or more affective episodes in 1 year), or an unstable comorbid medical condition. In addition, individuals meeting criteria for antisocial and borderline personality disorder or schizophrenia are excluded from this study.

Once stabilized (defined as 4 weeks of symptom scores averaging <7 on the 24-item version of the HRSD and <7 on the Bech-Rafaelsen Mania Scale while on a stable medication regimen), patients are reassigned to either IPSRT or ICM (in conjunction with the medication regimen that led to stabilization) for 2 years of monthly maintenance treatment. The maintenance phase of treatment consists of 3 months of bimonthly sessions followed by 21 months of monthly session. Thus, four treatment sequences are possible in this study: IPSRT followed by IPSRT; IPSRT followed by ICM; ICM followed by ICM; and ICM followed by IPSRT. See Figure 15.1 for a schematic depiction of the MTBD study design.

Although used as a comparison condition in MTBD, ICM is an important psychothera-peutic intervention in its own right. It should not be mistaken for an inactive control. Influenced by the medical model of clinical management, ICM focuses on fostering support, promoting treatment adherence, assessing symptoms, and providing psychoeducation.

Intensive Clinical Management visits and protocol pharmacotherapy

Figure 1S.1 Maintenance therapies in bipolar disorder: study design

Maintenance Therapies in Bipolar Disorder Study Design

RANDOM ASSIGNMENT TO ACUTE PHASE

•Acute treatment weekly until HRSD and Bech-Rafaelsen average < 7 over four weeks

•Patient and family attend psychoed ucation-al workshop

Intensive Clinical Management visits and protocol pharmacotherapy

•Acute treatment weekly until HRSD and Bech-Rafaelsen average < 7 over four weeks

•Patient and family attend psychoed ucation-al workshop

Intensive Clinical Management visits and protocol pharmacotherapy

Intensive Clinical Management visits and protocol pharmacotherapy

Maintenance treatment biweekly (x 12 weeks) followed by monthly (X 2 years) visits. Frequency of visits increased temporarily if patient experiences new episode.

Figure 1S.1 Maintenance therapies in bipolar disorder: study design

Thus, ICM incorporates many general psychotherapeutic strategies that contribute to the successful management of bipolar illness. See Table 15.2 for a summary of ICM techniques. In contrast to IPSRT, therapists providing ICM are proscribed from discussing interpersonal stressors and social rhythm stability. In MTBD, all therapists are trained to administer reliably both IPSRT and ICM.

In MTBD, all patients receive pharmacotherapy according to a specified algorithm (available from the authors). Unless contraindicated, pharmacotherapy begins with lithium. Neuroleptics, additional mood stabilizers, benzodiazepines, and antidepressants are added in stepwise fashion, guided by weekly symptom scores. Once stable, attempts are made to withdraw all medication except for the primary mood stabilizer (or combination of mood stabilizers, in some cases). If patients cannot tolerate a reduction of medications (that is, of an antidepressant or antipsychotic), they are permitted to remain on the combination that keeps them well. Once reassigned to the maintenance phase of the study, medication cannot be changed unless a recurrence is declared (except for 5 days of "rescue" medications, such as lorazepam, administered under specified conditions for subsyndromal hypomanic symptoms).

Table 1S.2 Intensive clinical management

Elements of intensive clinical management (ICM)

1. Education about bipolar disorder

2. Education about medications used to treat bipolar disorder

3. Education about basic sleep hygiene

4. Careful review of side effects

5. Medical and behavioral management of side effects

6. Nonspecific support

7. Education regarding early warning signs of impending episodes and use of rescue medication

8. 24-hour on-call service

Results

The first published report from the MTBD protocol examined the relative impact of ICM and IPSRT on stability of daily routines (Frank et al., 1997). This analysis included 38 subjects (18 receiving IPSRT and 20 receiving ICM) followed in the acute phase of treatment for up to 52 weeks. As measured by the SRM (Monk et al., 1991), a random regression analysis illustrated that individuals who received IPSRT achieved greater stability in their social rhythms when compared to ICM treatment over a similar time period (chi square = 3.96; P = 0.047). The two groups did not differ on levels of symptomatology over 52 weeks (measured by the HRSD and the Bech-Rafaelson; chi square = 0.12; P = 0.73). These analyses demonstrate that IPSRT effectively enhances stability of daily routines.

We have also reported on the effects of episode polarity on time to stabilization in the acute phase of the study (Hlastala et al., 1997; Kupfer et al., 2000). We first reported on differential time to stabilization among subjects treated for depression (n = 22), mania (n = 8), or a mixed state (n = 12) during the acute phase of the study (Hlastala et al., 1997), finding significant differences among groups (chi square = 14.80, P = 0.0006). Subsequent analyses of a larger sample (n = 151) demonstrated longer median times to stabilization in depressed and mixed/cycling subjects: 11.0 weeks for subjects treated for mania, 24.0 weeks for subjects treated for depression, and 40.3 weeks for subjects treated for mixed/cycling episodes. Between-group comparisons of survival analyses (time to stabilization) were significantly different (for all, P < 0.05). In the earlier report, although no specific treatment effects were found, among depressed subjects, those who received IPSRT had a median time to remission of 22 weeks, versus 40 weeks in subjects assigned to ICM. Although not statistically significant, this finding suggests that IPSRT may selectively hasten recovery from a depressive episode.

We have only recently begun to analyze data from the maintenance phase of the study. As shown in Figure 15.1, subjects can receive one of four possible treatment assignments in MTBD: IPSRT followed by IPSRT; IPSRT followed by ICM; ICM followed by ICM; or ICM followed by IPSRT. In one report, we looked at the effects of changing psychotherapy assignment between acute and maintenance treatment (Frank et al., 1999). Among the first 82 subjects to enter the maintenance phase of the study, we found that subjects who received the same treatment for both acute and maintenance phases (IPSRT/IPSRT or ICM/ICM) trended toward lower levels of manic and depressive symptomatology (P = 0.06) and had a significantly lower risk of recurrence (P = 0.03) over 52 weeks than those assigned to altered treatments (iPSRT/ICM or ICM/IPSRT). We also showed that subjects assigned to IPSRT in the acute phase who then "lost" it (IPSRT/ICM) had significantly higher symptom scores than the other three groups during the 52 weeks of maintenance treatment. These finding were particularly remarkable in light of the fact that, according to our protocol, patients change neither the timing of their appointments nor their therapists when treatment content is altered. Because only subjects who achieved stability in the acute phase were permitted to enter the maintenance phase, these data also suggest that treatments that get patients well keep them well (subjects who fail to achieve remission with their assigned treatment condition are withdrawn from the study). In keeping with our theory that stabilizing routines encourage wellness in patients suffering from bipolar disorder, we concluded that a constant treatment regimen contributes to enhanced stability in this population.

We also observed that subjects assigned to either IPSRT or ICM during the maintenance phase of MTBD remain relatively well (recurrence-free) compared to historical reports of subjects assigned to medication alone. It seems likely that both "high-dose" (IPSRT) and "low-dose" (ICM) adjunctive psychotherapy contribute to enhanced wellness in this population (Frank et al., 1999), resulting in improved stability for many of the patients in our protocol. In a subsequent analysis of the first 90 subjects to enter the preventative phase of the study, we found that, over time, patients assigned to IPSRT were increasingly likely to experience euthymia and decreasingly likely to experience periods characterized by depressive symptoms, compared to patients assigned to ICM (Frank, 1999).

Some subjects express a preference for assignment to IPSRT, stating that they want to receive psychotherapy (although these preferences do not affect the random assignment process). We believe that the desire for psychotherapy may play into observed dropout rates among groups. Thus far, dropout rates are highest among those assigned to ICM in both the acute and maintenance phases (25%; 8/32) and lowest among those assigned to ICM in the acute phase followed by IPSRT in the maintenance phase (6%; 2/31). Dropout rates in the IPSRT/ICM and IPSRT/IPSRT groups are intermediate to the other groups (19% or 6/32 and 15% or 4/27, respectively) (Swartz et al., 2001). Patients assigned to ICM in the acute phase who discover that they are again assigned to ICM for maintenance may drop out of the study and seek more intensive psychotherapy elsewhere. Alternately, some patients who are assigned to ICM initially and then assigned to IPSRT for maintenance may be relieved to "finally get psychotherapy", leading to lower attrition in this group.

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