ERRT for Bipolar Disorder
(BERRT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Tulsa
Must be taking: Bipolar medication
Disqualifiers: Recent mania, Substance use disorder, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.
Will I have to stop taking my current medications?
The trial requires that you have been stable on your bipolar medication for at least 2 months, so you will need to continue taking your current medications.
What data supports the effectiveness of the treatment ERRT-Bipolar Disorder?
Research suggests that people with bipolar disorder often experience intrusive mental images that can worsen anxiety and mood instability. Treatments targeting these images, like Imagery Based Emotion Regulation, have shown potential to reduce anxiety and improve mood stability, indicating that similar approaches like ERRT-Bipolar Disorder might also be effective.
12345Is ERRT safe for humans?
The available research suggests that similar therapies, like Eye Movement Desensitization and Reprocessing and Behavioral Activation, have been found to be safe for people with bipolar disorder, with no serious adverse events reported.
12678How is ERRT-Bipolar Disorder treatment different from other treatments for bipolar disorder?
ERRT-Bipolar Disorder is unique because it focuses on using imagery techniques to help patients manage intrusive and distressing mental images, which are common in bipolar disorder and can worsen anxiety and mood instability. This approach is different from traditional therapies like cognitive behavioral therapy (CBT) by specifically targeting emotional mental imagery to improve emotional regulation.
12569Eligibility Criteria
This trial is for adults with Bipolar Disorder (I or II) who have experienced a traumatic event over a month ago and suffer from frequent nightmares. Participants must be stable on bipolar medication for at least two months and not currently experiencing mania/hypomania, recent suicide attempts, hospitalizations, or untreated substance use disorders.Inclusion Criteria
I have been diagnosed with Bipolar disorder.
You have experienced a traumatic event at least one month before the study starts.
I have experienced nightmares at least once a week for the last month.
+1 more
Exclusion Criteria
Intellectual disability
Current or recent mania/hypomania within the last 3 months
Suicide attempt or hospitalization within the last 3 months
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Exposure, Relaxation, and Rescripting Therapy (ERRT) for Bipolar disorder once a week for five consecutive weeks
5 weeks
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at 1-week, 3-months, and potentially 1-year
1 year
3 visits (in-person)
Participant Groups
The study tests ERRT-Bipolar Disorder, a therapy aimed at reducing trauma-related nightmares and improving sleep in those with bipolar disorder. The effectiveness of this psychological intervention will be evaluated by its impact on the frequency and intensity of nightmares.
1Treatment groups
Experimental Treatment
Group I: Nightmare TreatmentExperimental Treatment1 Intervention
The nightmare treatment, Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder (ERRT-Bipolar Disorder), is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.
ERRT-Bipolar Disorder is already approved in United States for the following indications:
🇺🇸 Approved in United States as ERRT for:
- Trauma-related nightmares
- Sleep disturbances in trauma-exposed adults with bipolar disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of TulsaTulsa, OK
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Who Is Running the Clinical Trial?
University of TulsaLead Sponsor
References
The IBER study: study protocol for a feasibility randomised controlled trial of Imagery Based Emotion Regulation for the treatment of anxiety in bipolar disorder. [2022]Anxiety is highly prevalent in people diagnosed with bipolar disorder (BD), and can persist between acute episodes of mania and depression. Recent studies indicate that people with BD are prone to experiencing frequent, intrusive and emotional mental images which further fuel their levels of anxiety and mood instability. These intrusive emotional mental images represent a specific target for treatment for this disorder with the potential to reduce anxiety and improve mood stability. A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD. A feasibility trial is required in order to assess whether a full randomised controlled trial is indicated in order to evaluate this approach.
Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study. [2018]Traumatic events are frequent in bipolar patients and can worsen the course of the disease. Psychotherapeutic interventions for these events have not been studied so far. Twenty DSM-IV bipolar I and II patients with subsyndromal mood symptoms and a history of traumatic events were randomly assigned to Eye Movement Desensitization and Reprocessing therapy (n=10) or treatment as usual (n=10). The treatment group received between 14 and 18 Eye Movement Desensitization and Reprocessing sessions during 12 weeks. Evaluations of affective symptoms, symptoms of trauma and trauma impact were carried out by a blind rater at baseline, 2 weeks, 5 weeks, 8 weeks, 12 weeks and at 24 weeks follow-up. Patients in the treatment group showed a statistically significant improvement in depressive and hypomanic symptoms, symptoms of trauma and trauma impact compared to the treatment as usual group after intervention. This effect was only partly maintained in trauma impact at the 24 weeks follow-up visit. One patient dropped from Eye Movement Desensitization and Reprocessing group whereas four from the treatment as usual group. This pilot study suggests that Eye Movement Desensitization and Reprocessing therapy may be an effective and safe intervention to treat subsyndromal mood and trauma symptoms in traumatized bipolar patients.
Hypomanic Experience in Young Adults Confers Vulnerability to Intrusive Imagery After Experimental Trauma: Relevance for Bipolar Disorder. [2022]Emotional mental imagery occurs across anxiety disorders, yet is neglected in bipolar disorder despite high anxiety comorbidity. Furthermore, a heightened susceptibility to developing intrusive mental images of stressful events in bipolar disorder and people vulnerable to it (with hypomanic experience) has been suggested. The current study assessed, prospectively, whether significant hypomanic experience (contrasting groups scoring high vs. low on the Mood Disorder Questionnaire, MDQ) places individuals at increased risk of visual reexperiencing after experimental stress. A total of 110 young adults watched a trauma film and recorded film-related intrusive images for 6 days. Compared to the low MDQ group, the high MDQ group experienced approximately twice as many intrusive images, substantiated by convergent measures. Findings suggest hypomanic experience is associated with developing more frequent intrusive imagery of a stressor. Because mental imagery powerfully affects emotion, such imagery may contribute to bipolar mood instability and offer a cognitive treatment target.
Mood stability versus mood instability in bipolar disorder: a possible role for emotional mental imagery. [2022]A cognitive model of bipolar disorder suggests that mental imagery acts as an emotional amplifier of mood and may be heightened in bipolar disorder. First, we tested whether patients with bipolar disorder would score higher on mental imagery measures than a matched healthy control group. Second, we examined differences in imagery between patients divided into groups according to their level of mood stability. Mood ratings over approximately 6-months, made using a mobile phone messaging system, were used to divide patients into stable or unstable groups. Clinician decisions of mood stability were corroborated with statistical analysis. Results showed (I) compared to healthy controls, patients with bipolar disorder had significantly higher scores for general mental imagery use, more vivid imagery of future events, higher levels of intrusive prospective imagery, and more extreme imagery-based interpretation bias; (II) compared to patients with stable mood, patients with unstable mood had higher levels of intrusive prospective imagery, and this correlated highly with their current levels of anxiety and depression. The findings were consistent with predictions. Further investigation of imagery in bipolar disorder appears warranted as it may highlight processes that contribute to mood instability with relevance for cognitive behaviour therapy.
Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. [2023]CBT for patients with bipolar disorder has modest effects. Across disorders, mental imagery has been used to update CBT to increase effectiveness. In order to enhance CBT for bipolar disorder with imagery techniques, research is needed into emotional imagery quality and, related appraisals of imagery and their relationships with mood instability and subsequent behaviour in bipolar disorder.
The IBER study: a feasibility randomised controlled trial of imagery based emotion regulation for the treatment of anxiety in bipolar disorder. [2023]Intrusive mental imagery is associated with anxiety and mood instability within bipolar disorder and therefore represents a novel treatment target. Imagery Based Emotion Regulation (IBER) is a brief structured psychological intervention developed to enable people to use the skills required to regulate the emotional impact of these images.
Targeted psychosocial interventions for bipolar disorder. [2019]Pharmacotherapy is the foundation of treatment for bipolar disorder, but research suggests that adjunctive psychosocial interventions that are manualized, reproducible, time-limited, empirically supported, and strategically target a number of critical domains, can efficiently provide additional benefits. Psychoeducation as an adjunct of pharmacotherapy may be beneficial, but questions remain about the utility of this treatment for patients who are already compliant with medication treatment. Family educational interventions have demonstrated encouraging results in relapse prevention, but follow-up data are limited and application to patients who have limited social networks may be problematic. Reports on interpersonal and social rhythm therapy in patients with bipolar disorder are scarce, and what is available shows no differential effect on time to remission or relapse, but a significant impact on subsyndromal symptoms. Follow-up data suggest that patients receiving cognitive behavior therapy have significantly fewer bipolar episodes, shorter episodes, fewer hospitalizations, and less subsyndromal mood symptoms. It is unclear, however, if cognitive behavior therapy is superior to other active psychosocial treatments and whether its mechanism in patients with bipolar disorder is through changing dysfunctional cognitions or simply enhancing early symptom detection. Psychotherapies should be considered early in the course of illness to improve medication compliance and to help patients identify prodromes of relapse in order to take steps for prevention. In addition, some strategies may have a beneficial effect on residual symptoms, particularly symptoms of depression, and thus help move patients toward a more comprehensive functional recovery.
Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. [2022]Behavioural Activation (BA) is associated with a substantial evidence base for treatment of acute unipolar depression, and has promise as an easily disseminable psychological intervention for bipolar depression. Using a randomised multiple baseline case series design we examined the feasibility and acceptability of an adapted version of BA in a U.K. outpatient sample of 12 adults with acute bipolar depression. Participants were allocated at random to a 3-8 week wait period before being offered up to 20 sessions of BA. They completed outcome measures at intake, pre- and post-treatment and weekly symptom measures across the study period. Retention in therapy was high (11/12 participants completed the target minimum number of sessions), and all participants returning acceptability measures reported high levels of satisfaction with the intervention. No therapy-related serious adverse events were reported, nor were there exacerbations in manic symptoms that were judged to be a result of the intervention. The pattern of change on outcome measures is consistent with the potential for clinical benefit; six of the nine participants with a stable baseline showed clinically significant improvement on the primary outcome measure. The findings suggest adapted BA for bipolar depression is a feasible and acceptable approach that merits further investigation.
[Cognitive behavioral therapy for bipolar disorders]. [2019]Objectives and main techniques of cognitive behavior therapy for the treatment of bipolar disorder patients are described.