Intolerance-of-uncertainty therapy versus metacognitive therapy for generalized anxiety disorder in primary health care: A randomized controlled pilot trial.

OBJECTIVE: This randomized controlled pilot study investigated the feasibility of a future full-scale RCT to compare the effects of intolerance-of-uncertainty therapy (IUT) and metacognitive therapy (MCT) in primary health care patients with generalized anxiety disorder (GAD). Preliminary treatment effects were also evaluated. MATERIALS AND METHODS: 64 patients with GAD at a large primary health care center in Stockholm, Sweden, were randomized to IUT or MCT. Feasibility outcomes included participant recruitment and retention, willingness to receive psychological treatment, and therapists' competence in and adherence to treatment protocols. Self-reported scales were used to assess treatment outcomes, including worry, depression, functional impairment, and quality of life. RESULTS: Recruitment was satisfactory, and dropout was low. On a scale from 0 to 6, participants were satisfied with participating in the study (M = 5.17, SD = 1.09). Following brief training, therapists' competence was rated as moderate, and adherence was rated as weak to moderate. From pre- to post-treatment, reductions on the primary treatment outcome measure of worry were of a large effect size and statistically significant in both the IUT and MCT conditions (Cohen's d for IUT = -2.69, 95% confidence interval [-3.63, -1.76] and d for MCT = -3.78 [-4.68, -2.90]). The between-group effect size from pre- to post-treatment was large and statistically significant (d = -2.03 [-3.31, -0.75]), in favor of the MCT condition. CONCLUSION: It is feasible to carry out a full-scale RCT to compare the effects of IUT to MCT for patients with GAD in primary health care. Both protocols seem effective, and MCT seems superior to IUT, but a full-scale RCT is needed to confirm these conclusions. TRIAL REGISTRATION: ClinicalTrials.gov (no. NCT03621371).

Clinical effectiveness of care managers in collaborative primary health care for patients with depression: 12- and 24-month follow-up of a pragmatic cluster randomized controlled trial.

BACKGROUND: In previous studies, we investigated the effects of a care manager intervention for patients with depression treated in primary health care. At 6 months, care management improved depressive symptoms, remission, return to work, and adherence to anti-depressive medication more than care as usual. The aim of this study was to compare the long-term effectiveness of care management and usual care for primary care patients with depression on depressive symptoms, remission, quality of life, self-efficacy, confidence in care, and quality of care 12 and 24 months after the start of the intervention. METHODS: Cluster randomized controlled trial that included 23 primary care centers (11 intervention, 12 control) in the regions of Västra Götaland and Dalarna, Sweden. Patients ≥18 years with newly diagnosed mild to moderate depression (n = 376: 192 intervention, 184 control) were included. Patients at intervention centers co-developed a structured depression care plan with a care manager. Via 6 to 8 telephone contacts over 12 weeks, the care manager followed up symptoms and treatment, encouraged behavioral activation, provided education, and communicated with the patient's general practitioner as needed. Patients at control centers received usual care. Adjusted mixed model repeated measure analysis was conducted on data gathered at 12 and 24 months on depressive symptoms and remission (MADRS-S); quality of life (EQ5D); and self-efficacy, confidence in care, and quality of care (study-specific questionnaire). RESULTS: The intervention group had less severe depressive symptoms than the control group at 12 (P = 0.02) but not 24 months (P = 0.83). They reported higher quality of life at 12 (P = 0.01) but not 24 months (P = 0.88). Differences in remission and self-efficacy were not significant, but patients in the intervention group were more confident that they could get information (53% vs 38%; P = 0.02) and professional emotional support (51% vs 40%; P = 0.05) from the primary care center. CONCLUSIONS: Patients with depression who had a care manager maintained their 6-month improvements in symptoms at the 12- and 24-month follow-ups. Without a care manager, recovery could take up to 24 months. Patients with care managers also had significantly more confidence in primary care and belief in future support than controls. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02378272. Submitted 2/2/2015. Posted 4/3/2015.

A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial.

BACKGROUND: Exposure-based psychological treatment appears to have beneficial effects for several patient groups that commonly report distress related to persistent somatic symptoms. Yet exposure-based treatment is rarely offered in routine care. This may be because existing treatment protocols have been developed for specific symptom clusters or specific unwanted responses to somatic symptoms, and many clinics do not have the resources to offer all these specialised treatments in parallel. In preparation for a randomised controlled trial, we investigated the feasibility of a new and unified Internet-delivered exposure treatment (OSF.io: cnbwj) for somatic symptom disorder regardless of somatic symptom domain (e.g. cardiopulmonary, fatigue, gastrointestinal, pain), combination of unwanted emotions (e.g. anger, anxiety, fear, shame) and whether somatic symptoms are medically explained or not. We hypothesised that a wide spectrum of subgroups would show interest, that the treatment would be rated as credible, that adherence would be adequate, that the measurement strategy would be acceptable and that there would be no serious adverse events. METHODS: Single-group prospective cohort study where 33 self-referred adults with undifferentiated DSM-5 somatic symptom disorder took part in 8 weeks of unified Internet-delivered exposure treatment delivered via a web platform hosted by a medical university. Self-report questionnaires were administered online before treatment, each week during treatment, post treatment and 3 months after treatment. RESULTS: Participants reported a broad spectrum of symptoms. The Credibility/Expectancy mean score was 34.5 (SD = 7.0, range: 18-47). Participants completed 91% (150/165) of all modules and 97% of the participants (32/33) completed at least two exposure exercises. The average participant rated the adequacy of the rationale as 8.4 (SD = 1.5) on a scale from 0 to 10. The post-treatment assessment was completed by 97% (32/33), and 84% (27/32) rated the measurement strategy as acceptable. The Client Satisfaction Questionnaire mean score was 25.3 (SD = 4.7, range: 17-32) and no serious adverse events were reported. Reductions in subjective somatic symptom burden (the Patient Health Questionnaire 15; d = 0.90) and symptom preoccupation (the somatic symptom disorder 12; d = 1.17) were large and sustained. CONCLUSIONS: Delivering a unified Internet-delivered exposure-based treatment protocol for individuals with undifferentiated somatic symptom disorder appears to be feasible. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04511286 . Registered on August 13, 2020.

Outcomes of psychiatric interviews and self-rated symptom scales in people on sick leave for common mental disorders: an observational study.

OBJECTIVES: To investigate the correspondence between diagnoses on sick leave certificates and diagnoses made in structured psychiatric interviews. Secondary aims were to investigate length of sick leave by diagnoses on sick leave certificates, diagnoses made in structured interviews and symptom severity. DESIGN: Observational study consisting of a secondary analysis of data from a randomised controlled trial and an observational study. SETTING: The regions of Stockholm and Västra Götaland, Sweden. PARTICIPANTS: 480 people on sick leave for common mental disorders. INTERVENTIONS: Participants were examined with structured psychiatric interviews and self-rated symptom severity scales. OUTCOME MEASURES: (1) Sick leave certificate diagnoses, (2) diagnoses from the Mini International Neuropsychiatric Interview and the Self-rated Stress-Induced Exhaustion Disorder (SED) Instrument (s-ED), (3) symptom severity (Montgomery-Asberg Depression Rating Scale-self-rating version and the Karolinska Exhaustion Disorder Scale) and (4) number of sick leave days. RESULTS: There was little correspondence between diagnoses on sick leave certificates and diagnoses made in structured psychiatric interviews. Many participants on sick leave for SED, anxiety disorder or depression fulfilled criteria for other mental disorders. Most on sick leave for SED (76%) and anxiety disorder (67%) had depression (p=0.041). Length of sick leave did not differ by certificate diagnoses. Participants with SED (s-ED) had longer sick leave than participants without SED (144 vs 84 days; 1.72 (1.37-2.16); p<0.001). More severe symptoms were associated with longer sick leave. CONCLUSION: Diagnoses on sick leave certificates did not reflect the complex and overlapping nature of the diagnoses found in the structured psychiatric interviews. This finding is relevant to the interpretation of information from health data registers, including studies and guidelines based on these data. A result of clinical interest was that more severe symptoms predicted long-term sick leave better than actual diagnoses.

The Mini-International Neuropsychiatric Interview is useful and well accepted as part of the clinical assessment for depression and anxiety in primary care: a mixed-methods study.

BACKGROUND: Psychiatric complaints are common among primary care patients, with depression and anxiety being the most frequent. Diagnosis of anxiety and depression can be difficult, potentially leading to over- as well as under-diagnosis. The diagnostic process can be facilitated by incorporating structured interviews as part of the assessment. One such instrument, the Mini-International Neuropsychiatric Interview (MINI), has been established and accepted in psychiatric care. The purpose of this study was to explore the experiences and perceptions of the paper-and-pen version of MINI version 6.0 among patients and staff in primary care centers in Sweden. METHODS: The MINI was introduced at three primary care centers and was conducted by either therapists or general practitioners. Patients presented with symptoms that could suggest depression or anxiety disorders. The duration of the interview was recorded. The experiences and perceptions of 125 patients and their interviewers were collected using a structured questionnaire. Global satisfaction was measured with a visual-analog scale (0-100). Semi-structured interviews were conducted with 24 patients and three therapists, and focus groups were held with 17 general practitioners. Qualitative content analysis was used for the interviews and focus groups. The findings across the groups were triangulated with results from the questionnaires. RESULTS: The median global satisfaction with the MINI was 80 for patients and 86 for interviewers. General practitioners appreciated that the MINI identified comorbidities, as one-third of the patients had at least two psychiatric diagnoses. The MINI helped general practitioners attain a more accurate diagnosis. Patients appreciated that the MINI helped them recognize and verbalize their problems and did not find it intrusive. Patients and interviewers had mixed experiences with the yes-no format of the MINI, and the risk of subjective interpretations was acknowledged. Patients, general practitioners and therapists stated that the MINI contributed to appropriate treatment. The MINI assessment lasted 26 min on average (range 12 to 60 min). CONCLUSIONS: The paper-and-pen version of the MINI could be useful in primary care as part of the clinical assessment of patients with problems suggestive of depression or anxiety disorders. The MINI was well accepted by patients, general practitioners and therapists.