Condition category
Mental and Behavioural Disorders
Date applied
18/12/2019
Date assigned
25/03/2020
Last edited
13/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Eating disorders (EDs) are severe and often long-term psychiatric illnesses, featuring high rates of both medical and psychiatric comorbidity and a pronounced risk of death. Lifetime prevalence (age 15-60) of EDs in Sweden today is about 3.5%. A significant proportion of ED patients (25-50% depending on ED diagnosis) are still ill 10 years following treatment intake. Compulsive exercise (CE) is a common and prominent symptom in various ED presentations and in both genders. CE is often used to control body weight and shape, compensate for food intake, and/or to regulate negative affect. It is characterised by rigidity and an inability to stop exercising despite negative consequences. CE has been linked to more severe ED pathology, risk of suicide and lower remission rates. About 50% of Swedish ED patients, irrespective of diagnosis and gender, report CE, yet to date there are no treatments targeting CE in Swedish specialist ED care. There are, however, promising findings for a targeted cognitive behavioural therapy (CBT) intervention developed in the UK: the CompuLsive Exercise Activity Program (LEAP), which aims to promote functional beliefs and behaviours in relation to physical activity, and help patients regain control of their exercise behaviour. This study aims to evaluate its efficacy for ED patients in Swedish specialist care by comparing a group of patients with EDs who receive standard treatment with a group of patients who receive standard treatment plus LEAP.

Who can participate?
Male and female patients, aged 18 and over, with an eating disorder with compulsive exercise, entering outpatient care at a specialised ED treatment unit

What does the study involve?
Participants are randomly allocated to receive either standard treatment or standard treatment plus LEAP. LEAP is a cognitive behavioural group treatment that is supposed to be given as an addition to treatment as usual to patients suffering from eating disorders with compulsive exercise as a symptom. LEAP is delivered in 8 group sessions over 4 consecutive weeks. A group consists of 4-8 individuals. The aim of LEAP is to equip patients with knowledge and skills that enable them to challenge maladaptive beliefs and behaviours, regain control of their exercise behaviour, and participate in exercise that is appropriate in relation to age, goals, and health status. The control group receive treatment as usual (a medical contact, a therapeutic contact - most commonly CBT-E, possibly eating support, etc - this is individualised to suit each patient's needs).

What are the possible benefits and risks of participating?
The possible benefits include returning to a more healthy way of exercising and experiencing less compulsivity and rigidity in relation to exercise. The risk is that this intervention is not all that helpful and thus patients invest time and energy doing something that does not really help. On the other hand, extra time with a therapist/psychologist working on one of their core symptoms may probably at least not do any harm.

Where is the study run from?
1. Anorexi-bulimimottagningen, Sahlgrenska Universitetssjukhuset, Göteborg (Sweden)
2. Ätstörningsenheten Eriksbergsgården, Örebro (Sweden)

When is the study starting and how long is it expected to run for?
December 2017 to December 2021

Who is funding the study?
1. Söderström-Königska Foundation
2. ALF medicine projektmedel

Who is the main contact?
Dr Emma Forsén Mantilla
emma.forsen@ki.se

Trial website

Contact information

Type

Public

Primary contact

Dr Emma Forsén Mantilla

ORCID ID

Contact details

Centre for Eating Disorders Innovation
Nobelsväg 12A
Stockholm
171 65
Sweden
+46 (0)736543254
emma.forsen@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2018/1308-31 (ethics protocol)

Study information

Scientific title

Taking the LEAP: an effectiveness trial of the compuLsive Exercise Activity Program (LEAP) - a cognitive behavioural program specifically targeting compulsive exercise in patients with eating disorders

Acronym

LEAP

Study hypothesis

Primary: what are the treatment effects of LEAP on ED diagnosis, ED cognitions, CE behaviours and cognitions, BMI, emotion regulation and general psychopathology, after 3 months and at 6 month follow-up?
Secondary: are there initial factors (e.g. BMI, gender, emotion regulation, compulsivity) that predict a more favourable outcome for patients in the LEAP group?

Ethics approval

Approved 08/08/2018, Swedish regional board of ethics (FE 289, 171 77 Stockholm, Sweden; Tel: +46 (0)8 524 870 00 (vx); Email: kansli@stockholm.epn.se), ref: DNR: 2018/1308-31

Study design

Two-armed parallel open-label randomised naturalistic effectiveness superiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Eating disorders

Intervention

Eligible patients are recruited in collaboration with eating disorder specialist treatment units. Patient consenting to participate will be assigned experimental condition by an allocating investigator (AI), using an online random number generator, stratified by site, diagnosis, and gender. The AI is the only person with access to randomisation group data.

LEAP is a cognitive behavioural group treatment that is supposed to be given as an addition to treatment as usual to patients suffering from eating disorders with compulsive exercise as a symptom. LEAP is delivered in 8 group sessions over 4 consecutive weeks. A group consists of 4-8 individuals. The aim of LEAP is to equip patients with knowledge and skills that enable them to challenge maladaptive beliefs and behaviours, regain control of their exercise behaviour, and participate in exercise that is appropriate in relation to age, goals, and health status.

The control group receive treatment as usual (a medical contact, a therapeutic contact - most commonly CBT-E, possibly eating support, etc - this is individualised to suit each patient's needs).

Clinicians conducting pre- and post-assessments are blinded, and LEAP clinicians do not carry out assessments. Participants cannot be blinded to group, since LEAP deviates too much from standard ED treatment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Assessed initially and at 6-month follow-up (T3). All these outcome variables, except ED diagnosis, will also be assessed at the 3-month follow-up (T2):
1. Eating disorder (ED) diagnosis measured by the Structured Eating Disorder Interview
2. ED cognitions measured by the Eating Disorder Examination Questionnaire
3. Compulsive Exercise measured by the Compulsive Exercise Test

Secondary outcome measures

Assessed initially and at 6-month follow-up (T3). All these outcome variables, except ED diagnosis, will also be assessed at the 3-month follow-up (T2):
1. Body Mass Index (BMI)
2. General psychopathology measured by the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure

Overall trial start date

19/12/2017

Overall trial end date

19/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female patients, ≥18 years of age
2. AN, BN or OSFED (Atypical AN and BN/Binge Eating Disorder with low frequency and/or limited duration of symptoms)
3. Reporting CE at T1 (EDEQ item 27, see Instruments)
4. Entering outpatient care at a specialised ED treatment unit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. Inability to communicate in Swedish
2. Psychotic disorder
3. High suicide risk
4. BMI<14

Recruitment start date

09/11/2020

Recruitment end date

19/12/2021

Locations

Countries of recruitment

Sweden

Trial participating centre

Anorexi-bulimimottagningen, Sahlgrenska Universitetssjukhuset, Göteborg
Östra Sjukhuset, Vitaminvägen 17
Göteborg
41650
Sweden

Trial participating centre

Ätstörningsenheten Eriksbergsgården, Örebro
Eriksbergsgatan 4
Örebro
70230
Sweden

Sponsor information

Organisation

Karolinska Institute

Sponsor details

Nobelsväg 12a
Stockholm
171 77
Sweden
+46 (0)704843309
andreas.birgegard@ki.se

Sponsor type

University/education

Website

www.atstorning.se

Organisation

Centrum för psykiatriforskning, SLSO

Sponsor details

Norra stationsgatan 69
plan 7
Stockholm
113 64
Sweden
+46 (0)722483092
nitya.jayaram@ki.se

Sponsor type

Government

Website

www.psykiatriforskning.se

Funders

Funder type

Charity

Funder name

Söderström-Königska Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ALF medicine projektmedel

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers intend to publish the main results in 2022, in a peer-reviewed international journal (potentially The International Journal of Eating Disorders). Results tied to the secondary research questions will be published in a peer-reviewed international journal in 2022 or in the beginning of 2023. Results will also be disseminated at international ED conferences.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the researchers do not have ethical permission.

Intention to publish date

29/08/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/08/2020: The intention to publish date has been changed from 22/08/2020 to 09/11/2020. 25/03/2020: Uploaded protocol (not peer reviewed) as an additional file. 19/12/2019: Trial's existence confirmed by Swedish regional board of ethics.