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The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial.

ABSTRACT: Panic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3% of the population in Sweden. Untreated, panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity, morbidity and mortality, employment difficulties, and healthcare utilization. Cognitive behavioral approaches are the recommended first-line treatment for panic disorder; however, many patients in routine care receive another evidence-based psychotherapy, including psychodynamic therapy. Allowing patients to choose among evidence-based approaches to panic disorder may improve outcomes and reduce overall health costs. Trials comparing the 'gold standard' treatment for panic disorder to other evidence-based psychotherapies are needed, and also trials that can separate patient preferences for treatment from randomization effects on outcome, disability and healthcare utilization in the longer term.A phase 2/3 doubly-randomized controlled trial carried out in routine care with 216 adults (aged 18 to 70 years) with a primary diagnosis of DSM-IV Panic Disorder (with or without Agoraphobia). Within each clinic, patients are randomized to self-selection, random assignment of treatment, or wait-list. Patients choose or are randomly assigned to either Panic Control Treatment or Panic-Focused Psychodynamic Psychotherapy. Primary outcomes are changes in panic symptom severity, occupational status, and sickness-related absences from work at post-treatment and 6, 12 and 24 months post-treatment. Secondary outcomes include changes in agoraphobic avoidance, psychiatric comorbidity, disability, and healthcare utilization. The study also employs elements of an effectiveness trial as therapist and service-related effects on outcome will be estimated. Putative change mechanisms for the two treatments are also assessed.Cognitive behavioral and psychodynamic therapies are both evidence-based approaches that are routinely offered to panic disordered patients in Sweden. However, little is known about the relative effectiveness of these two approaches for panic/agoraphobia, work-related disability and healthcare utilization over the longer term. The current trial (POSE) also addresses the important but understudied issue of whether patient preference for a particular psychotherapeutic approach moderates outcome.ClinicalTrials.gov NCT01606592 (registered 19 March 2012).

SUBMITTER: Sandell R

PROVIDER: S-EPMC4393576 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial.

Sandell Rolf R Svensson Martin M Nilsson Thomas T Johansson Håkan H Viborg Gardar G Perrin Sean S

Trials 20150331

<h4>Background</h4>Panic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3% of the population in Sweden. Untreated, panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity, morbidity and mortality, employment difficulties, and healthcare utilization. Cognitive behavioral approaches are the recommended first-line treatment for panic disorder; however, many patients in routine care receive another evidence-based p ...[more]

PMID: 25873067

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Project description:Background. Psychodynamic psychotherapy is a psychological treatment approach that has a growing empirical base. Research has indicated an association between therapist-facilitated affective experience and outcome in psychodynamic therapy. Affect-phobia therapy (APT), as outlined by McCullough et al., is a psychodynamic treatment that emphasizes a strong focus on expression and experience of affect. This model has neither been evaluated for depression nor anxiety disorders in a randomized controlled trial. While Internet-delivered psychodynamic treatments for depression and generalized anxiety disorder exist, they have not been based on APT. The aim of this randomized controlled trial was to investigate the efficacy of an Internet-based, psychodynamic, guided self-help treatment based on APT for depression and anxiety disorders. Methods. One hundred participants with diagnoses of mood and anxiety disorders participated in a randomized (1:1 ratio) controlled trial of an active group versus a control condition. The treatment group received a 10-week, psychodynamic, guided self-help treatment based on APT that was delivered through the Internet. The treatment consisted of eight text-based treatment modules and included therapist contact (9.5 min per client and week, on average) in a secure online environment. Participants in the control group also received online therapist support and clinical monitoring of symptoms, but received no treatment modules. Outcome measures were the 9-item Patient Health Questionnaire Depression Scale (PHQ-9) and the 7-item Generalized Anxiety Disorder Scale (GAD-7). Process measures were also included. All measures were administered weekly during the treatment period and at a 7-month follow-up. Results. Mixed models analyses using the full intention-to-treat sample revealed significant interaction effects of group and time on all outcome measures, when comparing treatment to the control group. A large between-group effect size of Cohen's d = 0.77 (95% CI: 0.37-1.18) was found on the PHQ-9 and a moderately large between-group effect size d = 0.48 (95% CI: 0.08-0.87) was found on the GAD-7. The number of patients who recovered (had no diagnoses of depression and anxiety, and had less than 10 on both the PHQ-9 and the GAD-7) were at post-treatment 52% in the treatment group and 24% in the control group. This difference was significant, ?(2)(N = 100, d f = 1) = 8.3, p < .01. From post-treatment to follow-up, treatment gains were maintained on the PHQ-9, and significant improvements were seen on the GAD-7. Conclusion. This study provides initial support for the efficacy of Internet-delivered psychodynamic therapy based on the affect-phobia model in the treatment of depression and anxiety disorders. The results support the conclusion that psychodynamic treatment approaches may be transferred to the guided self-help format and delivered via the Internet.

Project description:BackgroundAdolescent depression is one of the largest health issues in the world and there is a pressing need for effective and accessible treatments.ObjectiveThis trial examines whether affect-focused internet-based psychodynamic therapy (IPDT) with therapist support is more effective than an internet-based supportive control condition on reducing depression in adolescents.MethodsThe trial included 76 adolescents (61/76, 80% female; mean age 16.6 years), self-referred via an open access website and fulfilling criteria for major depressive disorder. Adolescents were randomized to 8 weeks of IPDT (38/76, 50%) or supportive control (38/76, 50%). The primary outcome was self-reported depressive symptoms, measured with the Quick Inventory of Depressive Symptomatology for Adolescents (QIDS-A17-SR). Secondary outcomes were anxiety severity, emotion regulation, self-compassion, and an additional depression measure. Assessments were made at baseline, postassessment, and at 6 months follow-up, in addition to weekly assessments of the primary outcome measure as well as emotion regulation during treatment.ResultsIPDT was significantly more effective than the control condition in reducing depression (d=0.82, P=.01), the result of which was corroborated by the second depression measure (d=0.80, P<.001). IPDT was also significantly more effective in reducing anxiety (d=0.78, P<.001) and increasing emotion regulation (d=0.97, P<.001) and self-compassion (d=0.65, P=.003). Significantly more patients in the IPDT group compared to the control group met criteria for response (56% vs 21%, respectively) and remission (35% vs 8%, respectively). Results on depression and anxiety symptoms were stable at 6 months follow-up. On average, participants completed 5.8 (SD 2.4) of the 8 modules.ConclusionsIPDT may be an effective intervention to reduce adolescent depression. Further research is needed, including comparisons with other treatments.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) 16206254; http://www.isrctn.com/ISRCTN16206254.

Project description:BACKGROUND:Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. OBJECTIVE:The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. METHODS:A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). RESULTS:Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). CONCLUSIONS:Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. TRIAL REGISTRATION:Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb).

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The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial.

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The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial.

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