Evaluation of the Implementation of PED-t in a Naturalistic Setting

NCT ID: NCT04980781

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2022-12-31

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?

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Participants receiving PED-t

Participants, i.e. females with bulimia nervosa or binge eating disorder, are recruited for therapy in the trained ERC. The treatment program consists of 20 behavioral therapy sessions covering 16 weeks, and with single follow-up sessions at 2-, and 4- months post-therapy.

Participants are interviewed on the expectations to- and experiences from having therapy in the ECR, and monitored and evaluated on therapy effectiveness (i.e. diagnostic outcomes).

Group Type: EXPERIMENTAL

Physical exercise and dietary therapy (PED-t)

Intervention Type: BEHAVIORAL

Behavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual.

Therapists and management in ERC offering PED-t

Employees in the ECR and the management will be trained in giving PED-t in their facility, and will then perform therapy with a single group of participants recruited.

Therapists/employees trained in PED-t will be interviewed about their expectations to- and experiences from giving the PED-t, and also being monitored according to therapy manual fidelity.

The management at the facility offering PED-t will be interviewed about their experiences on administration and implementation of the PED-t in their facility.

Group Type: EXPERIMENTAL

Implementation program for PED-t in ERC

Intervention Type: PROCEDURE

Participating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops.

Interventions

Physical exercise and dietary therapy (PED-t)

Behavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual.

Intervention Type: BEHAVIORAL

Implementation program for PED-t in ERC

Participating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops.

Intervention Type: PROCEDURE

Other Intervention Names

PED-t; FAKT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian School of Sport Sciences

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

The Norwegian Women´s Public Health Association

OTHER

Sponsor Role: collaborator

Norwegian Council for Mental Health

OTHER

Sponsor Role: collaborator

The Dam Foundation

OTHER

Sponsor Role: collaborator

The Vibeke Skofterud Foundation

UNKNOWN

Sponsor Role: collaborator

Ostfold University College

OTHER

Sponsor Role: lead

Responsible Party

Therese Fostervold Mathisen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Therese F Mathisen, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Health and Welfare, Østfold University College

Locations

Fredrikstad Frisklivssentral (Exercise Referal Center in the municipality of Fredrikstad)

Fredrikstad, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 28494809 (View on PubMed)

Other Identifiers

40503

Identifier Type: -

Identifier Source: org_study_id