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Imagery rehearsal therapy and/or mianserin in treatment of refugees diagnosed with PTSD: Results from a randomized controlled trial.

ABSTRACT: Sleep disturbances are frequently part of the symptomatology in refugees with post-traumatic stress disorder (PTSD). It has been suggested that targeting sleep disturbances may enhance the outcome of PTSD treatment. However, randomized studies on the effect of treatment focusing on sleep disturbances in refugees with PTSD are lacking. The aim of this study was to examine add-on treatment with imagery rehearsal therapy (IRT) and/or mianserin against treatment as usual (TAU) alone in a sample of trauma-affected refugees with PTSD at 8-12 months follow-up. In a randomized controlled trial, 219 adult refugees diagnosed with PTSD and suffering from sleep disturbances were randomized to four groups (1:1:1:1) receiving, respectively, TAU, TAU + mianserin, TAU + IRT, and TAU + IRT + mianserin. The primary outcome was subjective sleep quality (Pittsburgh Sleep Quality Index) and the secondary outcomes included PTSD and depression symptoms, level of functioning and subjective well-being. The data were analysed using mixed models. The only significant effect of IRT was on level of functioning (p = .040, ES 0.44), whereas there was no significant effect of mianserin on any of the measured outcomes. Low adherence to both IRT (39%) and mianserin (20%) was observed. Contrary to our hypothesis, we did not find IRT or mianserin to be superior to TAU. The low adherence may potentially cause an underestimation of the effect of IRT and mianserin and indicates a necessity to further analyse the complex factors that may impact the motivation and ability of trauma-affected refugees to participate in and profit from available treatment options.

SUBMITTER: Sandahl H

PROVIDER: S-EPMC8365672 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMeta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy.MethodsA randomized controlled study with a non-inferiority design is carried out in three locations of a regional outpatient psychiatric clinic for refugees. Seventy Arabic-, English- or Danish-speaking adult refugees (aged 18-67 years) diagnosed with PTSD are randomized to 16 sessions of either music therapy or verbal therapy (standard treatment). All participants are offered medical treatment, psychoeducation by nurses, physiotherapy or body therapy and social counseling as needed. Outcome measures are performed at baseline, post therapy and at 6 months' follow-up. A blind assessor measures outcomes post treatment and at follow-up. Questionnaires measuring trauma symptoms (HTQ), quality of life (WHO-5), dissociative symptoms (SDQ-20, DSS-20) and adult attachment (RAAS) are applied, as well as physiological measures (salivary oxytocin, beta-endorphin and substance P) and participant evaluation of each session.DiscussionThe effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration.Trial registrationClinicalTrials.gov ID number NCT03574228, registered retrospectively on 28 June 2016.

Project description:Posttraumatic stress disorder (PTSD) is a prevalent condition associated with intimate relationship problems, and intimate relationship factors have been shown to affect individual PTSD treatment outcomes.To compare cognitive-behavioral conjoint therapy for PTSD (a manualized couple therapy delivered to patients with PTSD and their significant others to simultaneously treat PTSD symptoms and enhance relationship satisfaction) with a wait-list condition.Randomized controlled trial of heterosexual and same-sex couples (n = 40 couples; n = 80 individuals) in which one partner met criteria for PTSD according to the Clinician-Administered PTSD Scale, conducted from 2008 to 2012 in a Department of Veterans Affairs outpatient hospital setting in Boston, Massachusetts, and a university-based research center in Toronto, Ontario, Canada. Symptoms of PTSD, comorbid conditions, and relationship satisfaction were collected by blinded assessors at baseline, at mid treatment (median, 8.00 weeks [range, 1.71-20.43 weeks] after baseline), and at posttreatment (median, 15.86 weeks [range, 7.14-38.57 weeks] after baseline). An uncontrolled 3-month follow-up (median, 38.21 weeks [range, 28.43-50.57 weeks] after baseline) was also completed.Couples were randomly assigned to take part in the 15-session cognitive-behavioral conjoint therapy for PTSD protocol immediately (n = 20) or were placed on a wait list for the therapy (n = 20).Clinician-rated PTSD symptom severity was the primary outcome and was assessed with the Clinician-Administered PTSD Scale. Intimate relationship satisfaction, assessed with the Dyadic Adjustment Scale, patient- and partner-rated PTSD symptoms, and comorbid symptoms were secondary outcomes.PTSD symptom severity (score range, 0-136) was significantly more improved in the couple therapy condition than in the wait-list condition (mean change difference, -23.21; 95% CI, -37.87 to -8.55). Similarly, patients' intimate relationship satisfaction (score range, 0-151) was significantly more improved in couple therapy than in the wait-list condition (mean change difference, 9.43; 95% CI, 0.04-18.83). The time × condition interaction effect in the multilevel model predicting PTSD symptoms (t37.5 = -3.09; P = .004) and patient-reported relationship satisfaction (t68.5 = 2.00; P = .049) revealed superiority of the couple therapy compared with the wait list. Treatment effects were maintained at 3-month follow-up.Among couples in which one partner was diagnosed as having PTSD, a disorder-specific couple therapy, compared with a wait list for the therapy, resulted in decreased PTSD symptom severity and patient comorbid symptom severity and increased patient relationship satisfaction.clinicaltrials.gov Identifier: NCT00669981.

Project description:Background: Posttraumatic stress disorder (PTSD) is a serious and relatively common mental disorder causing a high burden of suffering. Whereas evidence-based treatments are available, dropout and non-response rates remain high. PTSD and Cluster C personality disorders (avoidant, dependent or obsessive-compulsive personality disorder; CPD) are highly comorbid and there is evidence for suboptimal treatment effects in this subgroup of patients. An integrated PTSD and CPD treatment may be needed to increase treatment efficacy. However, no studies directly comparing the efficacy of regular PTSD treatment and treatment tailored to PTSD and comorbid CPD are available. Whether integrated treatment is more effective than treatment focused on PTSD alone is important, since (1) no evidence-based guideline for PTSD and comorbid CPD treatment exists, and (2) treatment approaches to CPD are costly and time consuming. Present study design describes a randomized controlled trial (RCT) directly comparing trauma focused treatment with integrated trauma focused and personality focused treatment. Methods: An RCT with two parallel groups design will be used to compare the clinical efficacy and cost-effectiveness of "standalone" imagery rescripting (n = 63) with integrated imagery rescripting and schema therapy (n = 63). This trial is part of a larger research project on PTSD and personality disorders. Predictors, mediators and outcome variables are measured at regular intervals over the course of 18 months. The main outcome is PTSD severity at 12 months. Additionally, machine-learning techniques will be used to predict treatment outcome using biopsychosocial variables. Discussion: This study protocol outlines the first RCT aimed at directly comparing the clinical efficacy and cost-effectiveness of imagery rescripting and integrated imagery rescripting and schema therapy for treatment seeking adult patients with PTSD and comorbid cluster C personality pathology. Additionally, biopsychosocial variables will be used to predict treatment outcome. As such, the trial adds to the development of an empirically informed and individualized treatment indication process. Clinical Trial registration: ClinicalTrials.gov, NCT03833531.

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Imagery rehearsal therapy and/or mianserin in treatment of refugees diagnosed with PTSD: Results from a randomized controlled trial.

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