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      Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study

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          Abstract

          Background

          Women with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibility and acceptability of this intervention.

          Methods

          This mixed-methods study incorporated a two-arm pilot randomized controlled trial and qualitative evaluation of the feasibility and acceptability of the adapted THP – Brief Group version (THP-BGV) to a range of stakeholders. We recruited pregnant women at 12-30 weeks’ gestation through pregnancy schools within the University Hospital’s catchment area. Women in the intervention arm received five online sessions of the THP-BGV delivered by antenatal nurses. The intervention employed principles of cognitive behaviour therapy to provide psychoeducation, behaviour activation, problem-solving strategies and group support to participants. In the control arm, women received usual care consisting of routine online educational pregnancy classes aided by the antenatal nurses. The women were assessed for depressive symptoms with the Edinburgh Postnatal Depression Scale at baseline and 4-6 weeks post-intervention and also evaluated for anxiety, perceived social support, partner relationship, level of disability and sleep quality. In-depth interviews were conducted with women and other key stakeholders.

          Results

          Of the 99 consecutive women referred to the pregnancy schools, 91 (91.9%) were eligible and 88 (88.8%) consented to participate in the study and were randomized. Eighty-two (83%) completed the final assessments. Our main findings were that this preventive group intervention was feasible to be integrated into routine antenatal educational classes and it was valued by the women and delivery-agents. While the study was not powered to detect differences between intervention and control conditions, we found small trends towards reduction in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported.

          Conclusions

          Given the paucity of preventive interventions for perinatal depression in low and middle-income countries, a fully powered definitive randomized controlled trial of this feasible and acceptable intervention should be conducted.

          Trial registration

          The study was registered at Clinical Trails.gov ( NCT04819711) (Registration Date: 29/03/2021).

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12888-022-04499-6.

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          Most cited references48

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          Using thematic analysis in psychology

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            A brief measure for assessing generalized anxiety disorder: the GAD-7.

            Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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              The PHQ-9: validity of a brief depression severity measure.

              While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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                Author and article information

                Contributors
                atifr@liverpool.ac.uk
                Journal
                BMC Psychiatry
                BMC Psychiatry
                BMC Psychiatry
                BioMed Central (London )
                1471-244X
                6 January 2023
                6 January 2023
                2023
                : 23
                : 14
                Affiliations
                [1 ]GRID grid.16477.33, ISNI 0000 0001 0668 8422, Marmara University, School of Medicine, Division of Social Pediatrics, ; Istanbul, Turkey
                [2 ]GRID grid.16477.33, ISNI 0000 0001 0668 8422, Marmara University, School of Medicine, Department of Psychiatry, ; Istanbul, Turkey
                [3 ]GRID grid.16477.33, ISNI 0000 0001 0668 8422, Marmara University, Institute of Health Sciences, Social Pediatrics Doctorate Program, ; Istanbul, Turkey
                [4 ]GRID grid.16477.33, ISNI 0000 0001 0668 8422, Marmara University, School of Medicine, Department of Public Health, ; Istanbul, Turkey
                [5 ]GRID grid.43169.39, ISNI 0000 0001 0599 1243, School of Public Health, , Xi’an Jiaotong University, ; Xi’an, China
                [6 ]GRID grid.490844.5, Human Development Research Foundation, ; Islamabad, Pakistan
                [7 ]GRID grid.10025.36, ISNI 0000 0004 1936 8470, University of Liverpool, Department of Primary Care and Mental Health, ; Waterhouse Buildings Block B, Liverpool, L69 3LH UK
                Author information
                https://orcid.org/0000-0002-9885-7656
                https://orcid.org/0000-0001-6848-5516
                https://orcid.org/0000-0003-3396-8002
                https://orcid.org/0000-0003-1120-3498
                https://orcid.org/0000-0003-0475-8946
                https://orcid.org/0000-0003-0862-0303
                https://orcid.org/0000-0002-9540-9356
                https://orcid.org/0000-0002-0223-7234
                https://orcid.org/0000-0001-8656-4613
                https://orcid.org/0000-0002-5252-5189
                https://orcid.org/0000-0002-2066-4467
                Article
                4499
                10.1186/s12888-022-04499-6
                9816542
                36604685
                576582c0-2193-491c-867d-ef35498bd56a
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 5 September 2022
                : 26 December 2022
                Categories
                Research
                Custom metadata
                © The Author(s) 2023

                Clinical Psychology & Psychiatry
                perinatal depression,psychological interventions,thinking healthy program

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