Questions and Answers About the STEP-BD Depression Psychosocial Treatment Trial
1. Q. What was the goal of the STEP-BD depression psychosocial treatment trial and how did it fit into STEP-BD?
A. The study reported in the April 2007 issue of the Archives of General Psychiatry describes the results of a clinical trial examining the effectiveness of four psychosocial interventions for people with bipolar disorder who are experiencing a depressive episode. The clinical trial was part of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) research program, the largest, federally funded treatment trial ever conducted for bipolar disorder. STEP-BD enabled researchers to explore a range of treatment options related to bipolar disorder, including mood-stabilizing medications, antidepressants, atypical antipsychotic medications, and psychosocial interventions (talk therapies).
Once enrolled in the STEP-BD program, participants aged 15 or older received individualized care from their STEP-BD treatment provider that included the best available treatment options. This approach was called the Best Practice Pathway. Participants in the Best Practice Pathway who were age 18 or older and whose depression did not improve or who experienced a new depressive episode, could enter the randomized clinical trial that examined the effectiveness of different combinations of medication and psychosocial therapy for the depressive phase of bipolar disorder.
In this one-year randomized clinical trial, the goal of the psychosocial study was to determine if receiving intensive (and long-term) treatment with any one of the three psychosocial therapies offered in STEP-BD was more effective in relieving bipolar depression than receiving treatment with a brief, short-term talk therapy intervention.
2. Q. Why is the psychosocial treatment trial important?
A. Although various treatments currently are available for treating bipolar disorder, including medications and talk therapies, it is not known if psychosocial interventions, when received alongside medication, can help relieve bipolar-related depression and keep patients well in typical, real-world clinical settings. In addition, most previous clinical trials were conducted in single academic centers and included carefully selected groups of research participants who may be different from the people seeking care in everyday practice settings.
In this regard, the psychosocial treatment study in STEP-BD is unique because it included “real world” patients experiencing the early phases of a depressive episode, who were already receiving care for their bipolar disorder as part of STEP-BD. The therapists who delivered care in the psychosocial treatment study received STEP-BD training in the different psychosocial therapies by experts in the field. The training and ongoing supervision was of low intensity, consistent with what is typically available in clinical practice.
3. Q. How were participants selected for inclusion in the psychosocial treatment trial?
A. While enrolled in the STEP-BD Best Practice Pathway, participants were evaluated for depression at every follow-up visit. These clinic visits recorded and tracked participants’ treatment and assessed their symptoms and clinical status for the duration of participation in the study. If the study participants experienced a depressive episode, they could choose to leave the Best Practice Pathway and enter the randomized portion of STEP-BD; 366 participants did so.
The randomized acute depression study lasted 26 weeks and addressed the question of whether adding an antidepressant medication (buproprion or paroxetine) to an existing mood stabilizing medication is more effective for treating acute bipolar-related depression than adding a placebo pill. All participants in this portion were required to be on a mood stabilizing medication, such as lithium, valproate, carbamazepine or other mood stabilizer approved by the U.S. Food and Drug Administration.
These 366 participants also had the option of participating in the randomized psychosocial treatment study in which they would receive psychosocial treatment in addition to their medication treatment. Of the 366 participants who entered the randomized depression trial, 236 chose to enter the psychosocial portion. In addition, 57 STEP-BD participants who were enrolled in the Best Practice Pathway, but who were not part of the medication portion of the randomized depression trial, chose to enter the psychosocial study as well. Altogether, 293 participants took part in the psychosocial treatment study. Many of those who chose not to participate in the psychosocial portion of the study were already receiving psychotherapy on their own.
4. Q. What psychosocial interventions did participants receive?
A. Researchers randomly assigned participants to receive either a short-term collaborative care intervention or one of three longer-term intensive therapies that have been shown to help stabilize bipolar symptoms—cognitive-behavioral therapy (CBT), interpersonal and social rhythm therapy (IPSRT), or family-focused treatment (FFT). Collaborative care was considered the “control” intervention, meaning that the outcomes of this therapy were used as a baseline by which to compare the other three intensive therapies. All of these therapies focused on education about the illness, relapse prevention planning, and bipolar illness management interventions, and all but collaborative care consisted of up to 30, 50-minute sessions that took place over nine months.
Collaborative care, which consisted of three, 50-minute sessions over six weeks, provided participants with a workbook, an educational videotape and other information that aimed to help them understand and manage the illness, maintain adherence to medications, and develop a treatment contract geared toward preventing bipolar episodes.
In the CBT intervention group, participants received education about the illness. They learned to challenge negative thoughts or beliefs about bipolar disorder or its associated stressful life circumstances, developed schedules to stay active, and developed strategies to detect and cope with mood swings.
The focus of IPSRT was on attaining and maintaining regular social rhythms (daily routines and sleep/wake cycles) and the relationship of daily activities to mood and levels of social stimulation. IPSRT therapists encouraged participants to keep track of their daily routines (e.g., when they went to sleep, when they woke up, etc.) while working toward establishing stable social rhythms. Patients also worked to resolve key interpersonal problems related to grief, role transitions, interpersonal disputes, or interpersonal skill deficits.
In FFT, participants and their relatives (e.g., spouses and parents) were taught an understanding of bipolar illness, its course, treatment and management. Family members were taught how to recognize early warning signs that might predict an oncoming depressive or manic episode in the person with bipolar illness, and strategies to intervene when these warning signs occurred. Treatment included enhancing communication between the participants and their family members to improve the quality of family interactions, and problem-solving to manage conflicts related to the illness.
5. Q. What do the results from the STEP-BD psychosocial treatment trial tell us about the treatment of bipolar disorder?
A. The outcome measures that were used to evaluate success of the treatments were “time to recovery” (e.g., how quickly did people get well) and the total amount of time during the study year that participants remained “well” (measured by the probability of being well during any given month). To be considered “well” in the study, participants had to have no more than two symptoms of mild or moderate mania or depression.
Of the 293 STEP-BD participants in the psychosocial treatment study, 59 percent recovered from their depression; 41 percent either did not recover or left the study early.
Over the course of the study year, participants in the intensive psychotherapies (FFT, IPSRT, CBT) had a more successful recovery rate (64 percent) compared to the individuals in the collaborative care group (52 percent). Also, participants in the intensive psychotherapies who recovered did so faster (on average, after about 113 days) than those in the collaborative care group (after about 146 days). Furthermore, the participants in the intensive psychotherapies were one and a half times more likely to remain well during any given month of the study year than those in the collaborative care group.
The study also showed that in each of the four psychosocial treatment groups, participants who were also enrolled in the randomized medication portion of the trial got well faster than those who were not, even though all patients were receiving some type of medication. In addition, recovery time was faster in all four groups for those participants who had family supports available.
Differences among the three intensive psychosocial interventions were not statistically significant, but they are worth noting. Over the yearlong study, 77 percent of participants in the FFT recovered, compared to 65 percent of participants in IPSRT and 60 percent in CBT.
6. Q. What do the results mean for people with bipolar depression and the doctors who provide care for them?
A. This one-year study showed that, in conjunction with adequate mood stabilizing medications, intensive psychotherapy is more effective in helping people recover from a depressive episode, and stay well over a one-year period, than a brief collaborative care treatment. All three types of intensive psychosocial treatments had comparable benefits.
Overall, psychotherapy appears to be a vital part of the effort to stabilize episodes of depression in bipolar illness. These findings should help clinicians plan treatments for individuals recovering from an episode of bipolar depression.