Clinical trial NCT04980781: Evaluation of the Implementation of PED-t in a Naturalistic Setting
Official title: Evaluation of the Implementation of a New Therapy for Bulimia Nervosa and Binge Eating Disorder; Physical Exercise and Dietary Therapy (PED-t), in a Naturalistic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Keywords: remission
treatment
therapy
physical exercise
dietary therapy
diet
physical activity
naturalistic
Exercise referral centers
Healthy Living Centers
eating disorders
implementation
Lead sponsor: Ostfold University College
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: University of Tromso
name: The Norwegian Women´s Public Health Association
name: Norwegian Council for Mental Health
name: The Dam Foundation
name: The Vibeke Skofterud Foundation
First posted: 2021-07-28
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Employees and management in a ECR receive training in PED-t, and successively arrange the therapy. Experiences with the program training, and expectations to and experiences from giving the therapy, are the main research questions. Managements will be interviewed according to experiences with management of- and suitability of the therapy in the ECR

Eligible participants with bulimia nervosa or binge eating disorder are recruited for therapy in the ECR. Their expectations to- and experiences from having therapy in the ECR are the main research questions, in addition to evaluation of therapy success.

A previous RCT has evaluated the treatment efficiency by comparing it to a control group and another standardized treatment intervention. As such, the main focus of the current study is to evaluate experiences from arranging PED-t in a naturalistic setting, and secondly to evaluate if treatment efficiency can be replicated.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Eva-PED-t project will evaluate implementation of a new therapy for eating disorders, called PED-t (Physical Exercise and Dietary therapy), in a new treatment arena for such illnesses. By this, Eva-PED-t evaluates effectiveness- and efficacy outcomes, with the latter highlighting both the user-, the therapists- and the management perspectives. The research group behind this initiative comprises the founders of the PED-t, and holds extensive expertise on research methodology, eating disorders, health science, and exercise medicine, affiliated high-ranked research-intensive universities. Previous documentation of poor implementation of evidence-based knowledge in public health services reveal poor or no translation of new research findings for improved screening, treatment or medical procedures into real life settings. This may impair public health service outcomes, as less effective or ineffective treatment or procedures are routinely preferred. In a randomized controlled trial, the Eva-PED-t partnership recently found a new therapy for eating disorders (PED-t) to be comparable effective to the currently recommended treatment (NCT02079935). Specific advantages with PED-t, are the use of professionals not currently used in therapy of mental disorders, and the efficiency of arranging therapy in groups, hence effectively dealing with the high request for therapy. The Eva PED-t collaborative is motivated by the knowledge of high prevalence of mental illnesses, for which there is a need to improve treatment access and -efficiency. Adding to this scenario, is the new and more prevalent diagnosis of eating disorders, binge eating disorder, for which specialized health services have no prioritization for treatment. Addressing requirements for improved therapy access demands investigation of new treatments and new ways of delivery. The PED-t responds to this request, still recommendation for a broad implementation necessitate exploration of implementation strategies and experiences.

Detailed description: Implementation research intends to identify facilitating and obstructing elements in the process of transferring evidence-based practices from controlled settings to naturalistic settings. Unfortunately, the implementation of evidence-based knowledge is challenged by lack of institutional resources and insufficient prioritization by the management, and lack of prioritization by funders and academic researchers. As such, a lag time before evidence-based knowledge from research is translated in to real world practice is typically estimated to be about 14-20 years. The delay in implementation of evidence-based practice is found to be specifically relevant in health care services, hence, ultimately depriving patients from best practice. Exercise referral centers (ERC, also known as Healthy Living Centers) are part of the municipally public health care, providing support for improved healthy living behavior. Service users are confident by the professional skills in the ERC, and trust the service to be evidence-based. However, there are a wide variety in program approaches and methodology, most with no evidence-based foundation, and a lack of documentation on effects. Hence originally, the UK National Institute for Health and Clinical Excellence (NICE) recommended not to commission ERC in primary health care other than in well-designed research studies. The ERC's are in an early progress, still exploring their role in public health care and having stakeholders requesting evidence-based methods, and as such, identification of successful interventions at the ERC's is necessitated.

The Eva-PED-t has the potential to pick up on the shortfalls in documentation of effectiveness outcomes and exploration of efficacy of evidence-based interventions at the ERC's, and the poor implementation of evidence-based treatment in public health services in general. The EVA_PED intend to evaluate the implementation of the PED-t in the public health care services ERC in terms of effectiveness and efficacy, and by a mixed methods design. By relying on the original team behind the development of the PED-t to train the therapists, inform and supervise the management, and to provide support during implementation, this project has the potential to ease the implementation process. As such, the EVA-PED aim to follow the request to evaluate the total implementation success (i.e. the sum of the effectiveness of treatment and the experiences of implementation within the organization).

The researchers behind the EVA-PED finalized the evaluation of effectivity from PED-t on treatment of eating disorders in 2018 (NCT02079935), bringing optimism on increased therapy access, lowering barriers for treatment seeking behavior, and facilitating a more effective treatment delivery. Having the PED-t research team initiating Eva-PED-t, this project will bypass the delay in translation of evidence-based knowledge to real life settings. The Eva-PED-t has the potential to identify any elements undermining optimal uptake of this evidence-based treatment in public health services. Informed on previous challenges on successful implementation of evidence-based procedures, Eva-PED-t grasp on these most critical elements. Providing practical training and adequate time for preparations, mentoring during therapy operation, relying on therapy elements similar to what the therapists have practiced in their regular work, and by communicating, involving and motivating several levels in the organizations (management and therapists); the EVA_PED target the most critical elements previously found to impair successful implementation. Additionally, by involving former patients and therapists from the PED-t intervention as user groups, combined with the findings from in depth interviews in the corresponding groups of patients and therapists, the EVA-PED will evaluate adjustments of the therapy and arrangement according to their experiences and advices.

The EVA-PED-t project aims to evaluate the success of adopting and operating the evidence-based PED-t in naturalistic settings like ERC's, physiotherapy clinics and multidisciplinary medical centers. By this, the project intends to study effectiveness outcomes and efficacy outcomes, with the latter highlighting both the user perspectives, the therapists- and the management perspectives. A part of the efficacy outcomes, is evaluation on the treatment fidelity by individual therapists.

This generate the following main- and secondary research questions (RQ):

Main RQ:

1. Which elements promotes or discourages the implementation of PED-t according to; a) the therapists, and b) the management at the therapy cites?

Secondary RQ's:

1. How well is the implementation quality concerning treatment fidelity in a naturalistic setting?
2. What are the experiences amongst the patients receiving PED-t in a naturalistic setting?
3. How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis, in rating of quality of life, in intensity of symptoms for depression, anxiety and symptoms of an eating disorder, and in changes of eating- and exercise behavior?

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bulimia nervosa or binge eating disorder
* BMI 17.5 - 40
* Women

Exclusion Criteria:

* Being/planning to become pregnant during the therapy period
* Competitive athlete
* Concurrent severe symptom- or personality disorder in need of other treatment options

Primary outcomes:
measure: Expectations and readiness for running the PED-t (therapists)
timeFrame: 1 hour in June 2021, pre-therapy
measure: Experiences after running the PED-t (therapists)
timeFrame: 1 hour in December 2021, post-therapy
measure: Expectations on receiving PED-t in the ERC (patients)
timeFrame: 1 hour in August 2021, pre-therapy
measure: Experiences from receiving PED-t in the ERC (patients)
timeFrame: 1 hour in December 2021, post-therapy
measure: Management of training program and therapy in the ERC (leaders in the ERC)
timeFrame: 1 hour in August 2021, pre-therapy
measure: Management/implementation of PED-t in the ERC (leaders in the ERC)
timeFrame: 1 hour in December 2021, post-therapy
Secondary outcomes:
measure: Therapy manual fidelity
timeFrame: Once per 16 weeks (August-December)
measure: Rating of life quality before therapy
timeFrame: Pre-therapy, week 0
measure: Rating of life quality after therapy
timeFrame: Post-therapy, week 17
measure: Symptoms of depression before therapy
timeFrame: Pre-therapy, week 0
measure: Symptoms of depression after therapy
timeFrame: Post-therapy, week 17
measure: Symptoms of anxiety before therapy
timeFrame: Pre-therapy, week 0
measure: Symptoms of anxiety after therapy
timeFrame: Post-therapy, week 17
measure: Symptoms of compulsive exercise before therapy
timeFrame: Pre-therapy, week 0
measure: Symptoms of compulsive exercise after therapy
timeFrame: Post-therapy, week 17
measure: Symptoms of eating disorder before therapy
timeFrame: Pre-therapy, week 0
measure: Symptoms of eating disorder after therapy
timeFrame: Post-therapy, week 17
measure: Evaluation of an eating disorder diagnosis
timeFrame: Pre-therapy, week 0
measure: How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis?
timeFrame: Post-therapy, week 17
measure: Symptoms of eating disorder behavior
timeFrame: Once per week during 16 weeks of therapy
Other outcomes:
measure: Cardiorespiratory fitness (CRF) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Cardiorespiratory fitness (CRF) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Resting metabolic rate (RMR) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Resting metabolic rate (RMR) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Blood pressure in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Blood pressure in patients after therapy
timeFrame: Post-therapy, week 17
measure: Body composition (muscle mass) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Body composition (bone mass) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Body composition (visceral adipose tissue) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Body composition (fat mass) in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Body composition (muscle mass) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Body composition (bone mass) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Body composition (visceral adipose tissue) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Body composition (fat mass) in patients after therapy
timeFrame: Post-therapy, week 17
measure: Level of Physical activity in patients before therapy
timeFrame: Pre-therapy, week 0
measure: Level of Physical activity in patients after therapy
timeFrame: Post-therapy, week 17
measure: OSTRC Questionnaire for physical health issues
timeFrame: Once weekly during 16 weeks of therapy
Locations:
city: Fredrikstad
country: Norway
facility: Fredrikstad Frisklivssentral (Exercise Referal Center in the municipality of Fredrikstad)
Study officials:
affiliation: Faculty of Health and Welfare, Østfold University College
name: Therese F Mathisen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathisen TF, Rosenvinge JH, Pettersen G, Friborg O, Vrabel K, Bratland-Sanda S, Svendsen M, Stensrud T, Bakland M, Wynn R, Sundgot-Borgen J. The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder. BMC Psychiatry. 2017 May 12;17(1):180. doi: 10.1186/s12888-017-1312-4.