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      Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes

      research-article
      , MPsych 1 , 2 , , , MBBS, MD, FRANZCP 1 , 2 , 3 , , MPsych 1 , 3 , , PhD 2 , 4
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      type 1 diabetes, type 2 diabetes, diabetes-related distress, writing, Internet intervention, randomized controlled trial

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          Abstract

          Background

          Diabetes mellitus is Australia’s fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes.

          Objective

          The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes.

          Methods

          A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners’ offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups.

          Results

          This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken.

          Conclusions

          This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes.

          Trial Registration

          Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538)

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          Most cited references64

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          Assessing psychosocial distress in diabetes: development of the diabetes distress scale.

          The purpose of this study was to describe the development of the Diabetes Distress Scale (DDS), a new instrument for the assessment of diabetes-related emotional distress, based on four independent patient samples. In consultation with patients and professionals from multiple disciplines, a preliminary scale of 28 items was developed, based a priori on four distress-related domains: emotional burden subscale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. The new instrument was included in a larger battery of questionnaires used in diabetes studies at four diverse sites: waiting room at a primary care clinic (n = 200), waiting room at a diabetes specialty clinic (n = 179), a diabetes management study program (n = 167), and an ongoing diabetes management program (n = 158). Exploratory factor analyses revealed four factors consistent across sites (involving 17 of the 28 items) that matched the critical content domains identified earlier. The correlation between the 28-item and 17-item scales was very high (r = 0.99). The mean correlation between the 17-item total score (DDS) and the four subscales was high (r = 0.82), but the pattern of interscale correlations suggested that the subscales, although not totally independent, tapped into relatively different areas of diabetes-related distress. Internal reliability of the DDS and the four subscales was adequate (alpha > 0.87), and validity coefficients yielded significant linkages with the Center for Epidemiological Studies Depression Scale, meal planning, exercise, and total cholesterol. Insulin users evidenced the highest mean DDS total scores, whereas diet-controlled subjects displayed the lowest scores (P < 0.001). The DDS has a consistent, generalizable factor structure and good internal reliability and validity across four different clinical sites. The new instrument may serve as a valuable measure of diabetes-related emotional distress for use in research and clinical practice.
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            The prevalence of comorbid depression in adults with diabetes: a meta-analysis.

            To estimate the odds and prevalence of clinically relevant depression in adults with type 1 or type 2 diabetes. Depression is associated with hyperglycemia and an increased risk for diabetic complications; relief of depression is associated with improved glycemic control. A more accurate estimate of depression prevalence than what is currently available is needed to gauge the potential impact of depression management in diabetes. MEDLINE and PsycINFO databases and published references were used to identify studies that reported the prevalence of depression in diabetes. Prevalence was calculated as an aggregate mean weighted by the combined number of subjects in the included studies. We used chi(2) statistics and odds ratios (ORs) to assess the rate and likelihood of depression as a function of type of diabetes, sex, subject source, depression assessment method, and study design. A total of 42 eligible studies were identified; 20 (48%) included a nondiabetic comparison group. In the controlled studies, the odds of depression in the diabetic group were twice that of the nondiabetic comparison group (OR = 2.0, 95% CI 1.8-2.2) and did not differ by sex, type of diabetes, subject source, or assessment method. The prevalence of comorbid depression was significantly higher in diabetic women (28%) than in diabetic men (18%), in uncontrolled (30%) than in controlled studies (21%), in clinical (32%) than in community (20%) samples, and when assessed by self-report questionnaires (31%) than by standardized diagnostic interviews (11%). The presence of diabetes doubles the odds of comorbid depression. Prevalence estimates are affected by several clinical and methodological variables that do not affect the stability of the ORs.
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              • Article: not found

              Experimental disclosure and its moderators: a meta-analysis.

              Disclosing information, thoughts, and feelings about personal and meaningful topics (experimental disclosure) is purported to have various health and psychological consequences (e.g., J. W. Pennebaker, 1993). Although the results of 2 small meta-analyses (P. G. Frisina, J. C. Borod, & S. J. Lepore, 2004; J. M. Smyth, 1998) suggest that experimental disclosure has a positive and significant effect, both used a fixed effects approach, limiting generalizability. Also, a plethora of studies on experimental disclosure have been completed that were not included in the previous analyses. One hundred forty-six randomized studies of experimental disclosure were collected and included in the present meta-analysis. Results of random effects analyses indicate that experimental disclosure is effective, with a positive and significant average r-effect size of .075. In addition, a number of moderators were identified. (c) 2006 APA, All Rights Reserved.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                March 2017
                14 March 2017
                : 6
                : 3
                : e42
                Affiliations
                [1] 1Faces in the Street Urban Mental Health Research Institute St. Vincent's Health Australia SydneyAustralia
                [2] 2School of Psychiatry Faculty of Medicine University of New South Wales SydneyAustralia
                [3] 3Consultation Liaison Psychiatry St. Vincent's Health Australia SydneyAustralia
                [4] 4Black Dog Institute SydneyAustralia
                Author notes
                Corresponding Author: Joanna Crawford Joanna.Crawford@ 123456svha.org.au
                Author information
                http://orcid.org/0000-0002-4947-1626
                http://orcid.org/0000-0002-8542-6478
                http://orcid.org/0000-0002-0288-1564
                http://orcid.org/0000-0002-3872-9871
                Article
                v6i3e42
                10.2196/resprot.7151
                5373675
                28292741
                09f41c59-8f35-48a7-b64e-6a0a0922b260
                ©Joanna Crawford, Kay Wilhelm, Lisa Robins, Judy Proudfoot. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.03.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 12 December 2016
                : 10 January 2017
                : 15 January 2017
                : 16 January 2017
                Categories
                Protocol
                Protocol

                type 1 diabetes,type 2 diabetes,diabetes-related distress,writing,internet intervention,randomized controlled trial

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