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

Bulimia Nervosa Clinical Trial

— EVA-PEDt  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980781
• Other study ID #: 40503
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Ostfold University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
Norway	Fredrikstad Frisklivssentral (Exercise Referal Center in the municipality of Fredrikstad)	Fredrikstad

Sponsors (7)

Lead Sponsor	Collaborator
Ostfold University College	Norwegian Council for Mental Health, Norwegian School of Sport Sciences, The Dam Foundation, The Norwegian Women´s Public Health Association, The Vibeke Skofterud Foundation, University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness (CRF) in patients before therapy	CRF will be measured by performing a cardiopulmonary exercise test on a treadmill (ELG 90/200 Sports; Woodway, Weil am Rhein, Germany) with an incremental modified Balke protocol until exhaustion (Edvardsen,Hem, & Anderssen, 2014). Results are presented as ml oxygen consumed per kg bodymass per minute. Valid test requires measures of respiratory exchange ratio (RER) above 1.10, and lactate concentration above 7.0 mmol/L measured 1 min after test termination. A Borg scale rating above 17 may support evaluation if needed.	Pre-therapy, week 0
Other	Cardiorespiratory fitness (CRF) in patients after therapy	CRF will be measured by performing a cardiopulmonary exercise test on a treadmill (ELG 90/200 Sports; Woodway, Weil am Rhein, Germany) with an incremental modified Balke protocol until exhaustion (Edvardsen,Hem, & Anderssen, 2014). Results are presented as ml oxygen consumed per kg bodymass per minute. Valid test requires measures of respiratory exchange ratio (RER) above 1.10, and lactate concentration above 7.0 mmol/L measured 1 min after test termination. A Borg scale rating above 17 may support evaluation if needed.	Post-therapy, week 17
Other	Resting metabolic rate (RMR) in patients before therapy	RMR will be measured by performing indirect calorimetry; 20 minutes in total. A valid RMR (kcal per day) will be defined according to the current recommendation emphasizing the importance of a SS, being defined as 5 min periods with less than 10% CV for VO2 and VCO2.	Pre-therapy, week 0
Other	Resting metabolic rate (RMR) in patients after therapy	RMR will be measured by performing indirect calorimetry; 20 minutes in total. A valid RMR (kcal per day) will be defined according to the current recommendation emphasizing the importance of a SS, being defined as 5 min periods with less than 10% CV for VO2 and VCO2.	Post-therapy, week 17
Other	Blood pressure in patients before therapy	Resting blood pressure (systolic and diastolic) will be measured twice according to a standardized protocol (Mancia et al., 2013) with an automatic blood pressure device (Spot Vital Signs LXi; Welch Allyn, Skaneateles Falls, NY).	Pre-therapy, week 0
Other	Blood pressure in patients after therapy	Resting blood pressure (systolic and diastolic) will be measured twice according to a standardized protocol (Mancia et al., 2013) with an automatic blood pressure device (Spot Vital Signs LXi; Welch Allyn,Skaneateles Falls, NY).	Post-therapy, week 17
Other	Body composition (muscle mass) in patients before therapy	Body composition (i.e. muscle mass in kilogram, kg) will be measured by DXA.	Pre-therapy, week 0
Other	Body composition (bone mass) in patients before therapy	Body composition (i.e. bone mineral density in gram) will be measured by DXA.	Pre-therapy, week 0
Other	Body composition (visceral adipose tissue) in patients before therapy	Body composition (i.e. visceral adipose tissue in gram) will be measured by DXA.	Pre-therapy, week 0
Other	Body composition (fat mass) in patients before therapy	Body composition (i.e. fat mass in kilogram, kg, and percent, %, of total body mass) will be measured by DXA	Pre-therapy, week 0
Other	Body composition (muscle mass) in patients after therapy	Body composition (i.e. muscle mass in kilogram, kg) will be measured by DXA.	Post-therapy, week 17
Other	Body composition (bone mass) in patients after therapy	Body composition (i.e. bone mineral density in gram) will be measured by DXA.	Post-therapy, week 17
Other	Body composition (visceral adipose tissue) in patients after therapy	Body composition (i.e. visceral adipose tissue in gram) will be measured by DXA.	Post-therapy, week 17
Other	Body composition (fat mass) in patients after therapy	Body composition (i.e. fat mass in kilogram, kg, and percent, %, of total body mass) will be measured by DXA.	Post-therapy, week 17
Other	Level of Physical activity in patients before therapy	Level of physical activity will be measured by Aktigraph for 7 consecutive days using the ActiGraph accelerometer (ActiGraph GT3x; Actigraph, LCC, Pensacola, FL) placed on their right hip. Results are given as counts per minute, and will be compared to national representative results.	Pre-therapy, week 0
Other	Level of Physical activity in patients after therapy	Level of physical activity will be measured by Aktigraph for 7 consecutive days using the ActiGraph accelerometer (ActiGraph GT3x; Actigraph, LCC, Pensacola, FL) placed on their right hip. Results are given as counts per minute, and will be compared to national representative results.	Post-therapy, week 17
Other	OSTRC Questionnaire for physical health issues	Questionnaire developed to capture any illness or injuries depriving patients from weekly exercise sessions. Any episode is reported, and number of days with no exercise is given together with anatomical localization.	Once weekly during 16 weeks of therapy
Primary	Expectations and readiness for running the PED-t (therapists)	After training for PED-t; what are the therapists expectations to offering the PED-t and how able and ready do they feel about taking care of the patients? (semistructured interviews)	1 hour in June 2021, pre-therapy
Primary	Experiences after running the PED-t (therapists)	After running the PED-t; what are the therapists experiences from offering the PED-t and (semistructured interviews)	1 hour in December 2021, post-therapy
Primary	Expectations on receiving PED-t in the ERC (patients)	What are the patients expectations to receive PED-t in in the ERC? (semistructured interviews)	1 hour in August 2021, pre-therapy
Primary	Experiences from receiving PED-t in the ERC (patients)	What are the patients experiences from receiving PED-t in in the ERC? (semistructured interviews)	1 hour in December 2021, post-therapy
Primary	Management of training program and therapy in the ERC (leaders in the ERC)	What are the leaders experiences on managing therapy training for employees, and expectations to offer a new therapy in the local ERC? (semistructured interviews)	1 hour in August 2021, pre-therapy
Primary	Management/implementation of PED-t in the ERC (leaders in the ERC)	What are the leaders experiences on managing/implementing the PED-t in the local ERC? (semistructured interviews)	1 hour in December 2021, post-therapy
Secondary	Therapy manual fidelity	Electronic questionnaire measuring therapy manual fidelity, distributed on a weekly basis. Responding yes/no to whether specific topics has been addressed.	Once per 16 weeks (August-December)
Secondary	Rating of life quality before therapy	QoL measured with the Satisfaction with life scale. This is a short 5-item scale measuring overall contentment with life compared to personal standards and expectations, using a 5-point Likert scale ranging from1 (never true) to 7 (always true) (Diener, 1994)	Pre-therapy, week 0
Secondary	Rating of life quality after therapy	QoL measured with the Satisfaction with life scale. This is a short 5-item scale measuring overall contentment with life compared to personal standards and expectations, using a 5-point Likert scale ranging from1 (never true) to 7 (always true) (Diener, 1994)	Post-therapy, week 17
Secondary	Symptoms of depression before therapy	Measured with the Beck Depression Inventory. Consists of 22 items rated from 0 to 3, resulting in a total score up to 65 points, and where scoring of 21 or above indicates having symptoms of depression.	Pre-therapy, week 0
Secondary	Symptoms of depression after therapy	Measured with the Beck Depression Inventory. Consists of 22 items rated from 0 to 3 (one item scores 0-1), resulting in a total score up to 64 points, in which higher scoring means higher severity, and where scoring of 21 or above indicates having symptoms of depression.	Post-therapy, week 17
Secondary	Symptoms of anxiety before therapy	Measured with the Beck Anxiety Inventory. Consists of 21 items, scored from 0-3, with higher scoring indicating higher severity.	Pre-therapy, week 0
Secondary	Symptoms of anxiety after therapy	Measured with the Beck Anxiety Inventory. Consists of 21 items, scored from 0-3, with higher scoring indicating higher severity.	Post-therapy, week 17
Secondary	Symptoms of compulsive exercise before therapy	Measured with the Compulsive exercise test. CET is a 24-item instrument scored on a 5-point Likert scale (0 = never true, 5 = always true), and evaluated with five different subscale mean scores.	Pre-therapy, week 0
Secondary	Symptoms of compulsive exercise after therapy	Measured with the Compulsive exercise test. CET is a 24-item instrument scored on a 5-point Likert scale (0 = never true, 5 = always true), and evaluated with five different subscale mean scores.	Post-therapy, week 17
Secondary	Symptoms of eating disorder before therapy	Evaluated by the Eating Disorder Examination questionnaire. Consists of 28 items, for which 22 items are rated from 0-6, and 6 items consists of selfreported number of binge-eating or purging episodes. Higher items scorings means higher severity, a total score above 2.5 indicates a diagnosis of eating disorder (according to validation in a Norwegian sample), and diagnosis necessitates at least 1 episode of binge-eating and/or purging per week.	Pre-therapy, week 0
Secondary	Symptoms of eating disorder after therapy	Evaluated by the Eating Disorder Examination questionnaire. Consists of 28 items, for which 22 items are rated from 0-6, and 6 items consists of selfreported number of binge-eating or purging episodes. Higher items scorings means higher severity, a total score above 2.5 indicates a diagnosis of eating disorder (according to validation in a Norwegian sample), and diagnosis necessitates at least 1 episode of binge-eating and/or purging per week.	Post-therapy, week 17
Secondary	Evaluation of an eating disorder diagnosis	Evaluation on diagnosis by the Eating Disorder Examination questionnaire (EDE-q) and clinical interview to manually affirm symptoms reported in EDE-q.	Pre-therapy, week 0
Secondary	How effective is the PED-t in a naturalistic setting, evaluated in remission from diagnosis?	Evaluation on diagnosis by the Eating Disorder Examination questionnaire (EDE-q) and clinical interview to manually affirm symptoms reported in EDE-q.	Post-therapy, week 17
Secondary	Symptoms of eating disorder behavior	Selfreported number of binge-eating episodes and purging episodes per week.	Once per week during 16 weeks of therapy