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An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity.

ABSTRACT: Web-based interventions are becoming an alternative of treatment aimed to support behavioral changes and several advantages over traditional treatments are reported. New ways of delivering an intervention may result in new challenges regarding monitoring of treatment fidelity (TF) which is essential to ensure internal and external validity. Despite the importance of the theme, only a few studies in this field are reported.To examine TF of a mobile phone delivered intervention based on Acceptance and Commitment Therapy (ACT) with electronic diaries and written situational feedback for persons with diabetes mellitus type 2, the recommendations from the Behavior Change Consortium (BCC) established by The National Institutes of Health (NHI) were applied. To analyze fidelity, they recommend 5 areas to be investigated (1) design of the study, (2) provider training, (3) delivery of treatment, (4) receipt of treatment, and (5) enactment of treatment. In the current study, these areas were examined based on the analysis of therapists' adherence to the treatment protocol and participants' and therapists' experience with the intervention.To investigate the therapists' adherence to the treatment protocol, a total of 251 written feedback text messages were divided into text segments. Qualitative thematic analyses were then performed to examine how ACT and other therapeutic processes were used in the feedback by the therapists. For the therapists' and participants' experience analysis, participants answered a self-reported questionnaire and participated in 2 interviews. The therapists continuously reported their experiences to the researcher responsible for the project.The results show high adherence to the TF strategies 20/21 (95%) applicable items of the fidelity checklist recommended by NHI BCC were identified in the present study. Measured provider skill acquisition post-training was the only item absent in the fidelity checklist. The results also show high therapists' adherence to the treatment protocol. All ACT processes (values, committed action, acceptance, contact with the present moment, self as context and cognitive defusion) were found in the coded text segments of the feedback in addition to communication and motivation strategies. For 336/730 (46%) of total possible text segments coded independently by 2 researchers, the interrater reliability measured by Cohen's kappa was .85. The evaluation of participants' and therapists' experience with the intervention was generally positive.Based on the analyses of therapists' adherence to the treatment protocol grounded by ACT-principles and participants' and therapists' experience with the intervention, the 5 areas of TF recommended by NHI BCC were analyzed indicating a high level of TF. These results ensure an appropriate level of internal and external validity of the study and reliable intervention results and facilitate a precise replication of this intervention concept. Web-based psychological interventions to support people with chronic conditions are becoming increasingly more common. This study supports the results from a previous study which indicated that ACT could be reliably delivered in a written web-based format.ClinicalTrials.gov NCT01297049; https://clinicaltrials.gov/ct2/show/NCT01297049 (Archived by WebCite at http://www.webcitation.org/70WC4Cm4T).

SUBMITTER: Nes AAG

PROVIDER: S-EPMC6053615 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity.

Nes Andréa Aparecida Gonçalves AAG van Dulmen Sandra S Brembo Espen Andreas EA Eide Hilde H

JMIR mHealth and uHealth 20180703 7

<h4>Background</h4>Web-based interventions are becoming an alternative of treatment aimed to support behavioral changes and several advantages over traditional treatments are reported. New ways of delivering an intervention may result in new challenges regarding monitoring of treatment fidelity (TF) which is essential to ensure internal and external validity. Despite the importance of the theme, only a few studies in this field are reported.<h4>Objective</h4>To examine TF of a mobile phone deliv ...[more]

PMID: 29970357

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Project description:Psychological interventions have a long history of successful treatment of patients suffering from mental health and certain medical conditions. At the same time, psychotherapy research has revealed key areas of growth for optimizing patient care. These include identifying novel treatment delivery methods that increase treatment adherence, developing new strategies to more effectively address the ever-growing population of patients with comorbid conditions, and elucidating the mechanisms by which effective treatments work in order to further refine their design. Acceptance and commitment therapy (ACT) is an empirically supported psychotherapy that offers promise for patients suffering from a wide range of mental and physical conditions, while addressing these gaps and challenges in the field. ACT rests on the fundamental premise that pain, grief, disappointment, illness, and anxiety are inevitable features of human life, with the therapeutic goal of helping individuals productively adapt to these types of challenges by developing greater psychological flexibility rather than engaging in counterproductive attempts to eliminate or suppress undesirable experiences. This is achieved through committed pursuit of valued life areas and directions, even in the face of the natural desire to escape or avoid painful and troubling experiences, emotions, and thoughts. ACT is transdiagnostic (applies to more than one condition), process-focused, and flexibly delivered. In a relatively short period of time, ACT has been effectively implemented across a broad range of therapeutic settings, including mental health, primary care, and specialty medical clinics. ACT has also been delivered in a variety of formats, including 1-day group workshops, online and smartphone applications, and telehealth. Focus on how best to package and deliver treatment to meet the unique needs of different patient populations helps to ensure treatment adherence and has fostered successful application of ACT for patients in everyday clinical settings.

Project description:BackgroundTheory-based intervention materials must be carefully adapted to meet the needs of users with specific physical conditions. Acceptance and Commitment Therapy (ACT) has been adapted successfully for cancer, chronic pain, diabetes, irritable bowel syndrome, multiple sclerosis, and a range of other conditions, but not so far for people receiving renal haemodialysis. This paper presents findings from a study to adapt ACT-based intervention materials specifically for renal dialysis.MethodsDraft written materials consisting of four stories depicting fictitious individuals who used ACT-related techniques to help overcome different challenges and difficulties related to dialysis were adapted using a systematic patient consultation process. The participants were 18 people aged 19-80 years, with chronic kidney disease and receiving renal dialysis. Individual, semi-structured interviews were conducted to elicit participants' views about how the content of the draft materials should be adapted to make them more realistic and relevant for people receiving renal dialysis and about how the materials should be presented and delivered to people receiving renal dialysis. The interview transcripts were analysed using a qualitative adaptation of the Delphi method in which themes are used as a framework for translating feedback into proposals for modifications.ResultsThe analysis of patient feedback supported the use of patient stories but suggested they should be presented by video and narrated by real dialysis patients. They also indicated specific adaptations to make the stories more credible and realistic. Participant feedback was translated into proposals for change that were considered along with clinical, ethical and theoretical factors. The outcome was a design for a video-based intervention that separated the stories about individuals from the explanations of the specific ACT techniques and provided greater structure, with material organised into smaller chunks. This intervention is adapted specifically for people receiving renal dialysis while retaining the distinctive theoretical principles of ACT.ConclusionsThe study shows the value of consulting patients in the development of intervention materials and illustrates a process for integrating patient feedback with theoretical, clinical and practical considerations in intervention design.

Project description:IntroductionIntegrating diabetes self-management into daily life involves a range of complex challenges for affected individuals. Environmental, social, behavioural and emotional psychological factors influence the lives of those with diabetes. The aim of this study is to evaluate the impact of a stress management group intervention based on acceptance and commitment therapy (ACT) among adults living with poorly controlled type 1 diabetes.Methods and analysisThis study will use a randomised controlled trial design evaluating treatment as usual (TAU) and ACT versus TAU. The stress management group intervention will be based on ACT and comprises a programme divided into seven 2-hour sessions conducted over 14 weeks. A total of 70 patients who meet inclusion criteria will be recruited over a 2-year period with follow-up after 1, 2 and 5 years.The primary outcome measure will be HbA1c. The secondary outcome measures will be the Depression Anxiety Stress Scales, the Swedish version of the Hypoglycemia Fear Survey, the Swedish version of the Problem Areas in Diabetes Scale, The Summary of Self-Care Activities, Acceptance Action Diabetes Questionnaire, Swedish Acceptance and Action Questionnaire and the Manchester Short Assessment of Quality of Life. The questionnaires will be administered via the internet at baseline, after sessions 4 (study week 7) and 7 (study week 14), and 6, 12 and 24 months later, then finally after 5 years. HbA1c will be measured at the same time points.Assessment of intervention effect will be performed through the analysis of covariance. An intention-to-treat approach will be used. Mixed-model repeated measures will be applied to explore effect of intervention across all time points.Ethics and disseminationThe study has received ethical approval (Dnr: 2016/14-31/1). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders.Trial registration numberNCT02914496; Pre-results.

Project description:BackgroundEating disorders (EDs) among individuals with type 1 diabetes (T1D) increase the risk of early and severe diabetes-related medical complications and premature death. Conventional eating disorder (ED) treatments have been largely ineffective for T1D patients, indicating the need to tailor treatments to this patient population and the unique conditions under which ED symptoms emerge (in the context of a chronic illness with unrelenting demands to control blood glucose, diet and exercise). The current study was a pilot open trial of iACT, a novel intervention for EDs in T1D grounded in Acceptance and Commitment Therapy (ACT). iACT was based on the premise that ED symptoms emerge as individuals attempt to cope with T1D and related emotional distress. iACT taught acceptance and mindfulness as an alternative to maladaptive avoidance and control, and leveraged personal values to increase willingness to engage in T1D management, even when it was upsetting (e.g., after overeating). A tailored mobile application ("app") was used in between sessions to facilitate the application of ACT skills in the moment that individuals are making decisions about their diabetes management.MethodsAdults with T1D who met criteria for an ED completed 12 sessions of iACT (with three optional tapering sessions). In addition to examining whether treatment was acceptable and feasible (the primary aim of the study), the study also examined whether iACT was associated with increased psychological flexibility (i.e., the ability to have distressing thoughts/feelings about diabetes while pursuing personally meaningful values), and improvements in ED symptoms, diabetes management and diabetes distress.ResultsTreatment was acceptable to T1D patients with EDs and feasible to implement. Participants reported increased psychological flexibility with diabetes-related thoughts/feelings, and less obstruction and greater progress in pursuing personal values. There were large effects for change in ED symptoms, diabetes self-management and diabetes distress from baseline to end-of-treatment (Cohen's d = .90-1.79). Hemoglobin A1c also improved, but the p-value did not reach statistical significance, p = .08.ConclusionsFindings provide preliminary evidence for iACT to improve outcomes for T1D patients with EDs and support further evaluation of this approach in a controlled trial.Trial registrationNCT02980627 . Registered 8 July 2016.

Project description:BackgroundGeneralized anxiety disorder (GAD) is characterized by excessive worry that is difficult to control and has high comorbidity with mood disorders including depression. Individuals experience long wait times for diagnosis and often face accessibility barriers to treatment. There is a need for a digital solution that is accessible and acceptable to those with GAD.ObjectiveThis paper aims to describe the development of a digital intervention prototype of acceptance and commitment therapy (ACT) for GAD that sits within an existing well-being app platform, BioBase. A pilot feasibility study evaluating acceptability and usability is conducted in a sample of adults with a diagnosis of GAD, self-referred to the study.MethodsPhase 1 applied the person-based approach (creation of guiding principles, intervention design objectives, and the key intervention features). In Phase 2 participants received the app-based therapeutic and paired wearable for 2 weeks. Self-report questionnaires were obtained at baseline and posttreatment. The primary outcome was psychological flexibility (Acceptance and Action Questionnaire-II [AAQ-II]) as this is the aim of ACT. Mental well-being (Warwick-Edinburgh Mental Well-being Scale [WEMWBS]) and symptoms of anxiety (7-item Generalized Anxiety Disorder Assessment [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were also assessed. Posttreatment usability was assessed via self-report measures (System Usability Scale [SUS]) in addition to interviews that further explored feasibility of the digital intervention in this sample.ResultsThe app-based therapeutic was well received. Of 13 participants, 10 (77%) completed the treatment. Results show a high usability rating (83.5). Participants found the digital intervention to be relevant, useful, and helpful in managing their anxiety. Participants had lower anxiety (d=0.69) and depression (d=0.84) scores at exit, and these differences were significantly different from baseline (P=.03 and .008 for GAD-7 and PHQ-9, respectively). Participants had higher psychological flexibility and well-being scores at exit, although these were not significantly different from baseline (P=.11 and .55 for AAQ-II and WEMWBS, respectively).ConclusionsThis ACT prototype within BioBase is an acceptable and feasible digital intervention in reducing symptoms of anxiety and depression. This study suggests that this intervention warrants a larger feasibility study in adults with GAD.

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An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity.

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An mHealth Intervention for Persons with Diabetes Type 2 Based on Acceptance and Commitment Therapy Principles: Examining Treatment Fidelity.

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