Taking the LEAP: an evaluation of the compuLsive Exercise Activity Program (LEAP) in patients with eating disorders

ISRCTN	ISRCTN80711391
DOI	https://doi.org/10.1186/ISRCTN80711391
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2018/1308-31 (ethics protocol)
Sponsors	Karolinska Institute, Centrum för psykiatriforskning, SLSO
Funders	Söderström-Königska Foundation, ALF medicine projektmedel, Centre for Psychiatry Research (CPF; The Stockholm County Council)

Submission date: 18/12/2019
Registration date: 25/03/2020
Last edited: 02/10/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 1 individual session and 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)
3. Ätstörningsenheten, Akademiska Sjukhuset, Uppsala (Sweden)
4. Stockholms centrum för ätstörningar, Stockholm, (Sweden)
All in collaboration with Karolinska Institute, the department of medical biostatistics and
epidemiology (MEB).

When is the study starting and how long is it expected to run for?
December 2017 to December 2025

Who is funding the study?
1. Söderström-Königska Foundation
2. ALF medicine projektmedel
3. Centre for Psychiatry Research (CPF; The Stockholm County Council)

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

Contact information

Dr Emma Forsén Mantilla
Public

Centre for Eating Disorders Innovation
Nobelsväg 12A
Stockholm
171 65
Sweden

Phone	+46 (0)736543254
Email	emma.forsen@ki.se

Study information

Primary study design	Interventional
Study design	Two-armed parallel open-label randomized naturalistic effectiveness superiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	LEAP
Study objectives	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(s)	Current ethics approval as of 14/07/2021: 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, 2020-01173, 2021-02870 Previous 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
Health condition(s) or problem(s) studied	Eating disorders
Intervention	Current interventions as of 14/07/2021: 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 1 individual session and 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. Previous interventions: 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
Primary outcome measure(s)	Current primary outcome measure as of 14/07/2021: 1. Eating disorder (ED) diagnosis measured by the Eating Disorder Examination (EDE) or the Structured Eating Disorder Interview (SEDI) at baseline and 6 months 2. ED cognitions measured by the Eating Disorder Examination Questionnaire (EDEQ) at baseline, 3, and 6 months 3. Compulsive Exercise measured by the Compulsive Exercise Test (CET) at baseline, 3, and 6 months 4. Body Mass Index (BMI) at baseline, 3, and 6 months 5. The difficulties in emotion regulation scale (DERS) at baseline, 3, and 6 months Previous 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
Key secondary outcome measure(s)	Current secondary outcome measures as of 14/07/2021: 1. General psychopathology measured by the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure at baseline, 3, and 6 months 2. Active Q at baseline, 3, and 6 months 3. Patient rated treatment content (to control for potential efforts geared at CE in the TAU group) at baseline and 6 months 4. Feasibility and acceptability questionnaire (patient satisfaction with LEAP, only LEAP group) at baseline and 6 months Previous 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
Completion date	19/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Key inclusion criteria	Current participant inclusion criteria as of 14/07/2021: 1. Male and female patients, ≥18 years of age 2. AN, BN or OSFED (Atypical AN, BN/Binge Eating Disorder with low frequency and/or limited duration of symptoms, and Purging Disorder) 3. Reporting CE at T1 (EDEQ item 27, see Instruments) 4. Entering outpatient care at a specialised ED treatment unit Previous 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
Key exclusion criteria	1. Inability to communicate in Swedish 2. Psychotic disorder 3. High suicide risk 4. BMI<14
Date of first enrolment	09/11/2021
Date of final enrolment	19/12/2024

Locations

Countries of recruitment

Sweden

Study participating centres

Anorexi-bulimimottagningen, Sahlgrenska Universitetssjukhuset, Göteborg

Östra Sjukhuset, Vitaminvägen 17
Göteborg
41650
Sweden

Ätstörningsenheten Eriksbergsgården, Örebro

Eriksbergsgatan 4
Örebro
70230
Sweden

Ätstörningsenheten Akademiska Sjukhuset

Akademiska Sjukhuset
Uppsala
75185
Sweden

StockholmsCentrum för Ätstörningar (SCÄ)

Wollmar Yxkullsgatan 27B
Stockholm
11850
Sweden

Vuxenpsykiatrimottagning Ätstörning Lund

Baravägen 1
Lund
221 85
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	23/07/2021	26/07/2021	Yes	No
Other publications	Patients' experiences	01/10/2024	02/10/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file		20/12/2019	25/03/2020	No	No

Additional files

ISRCTN80711391_PROTOCOL_20Dec19.pdf: uploaded 25/03/2020

Editorial Notes

02/10/2024: Publication reference added.
08/11/2023: The following changes have been made:
1. The recruitment end date has been changed from 19/12/2023 to 19/12/2024.
2. The overall study end date has been changed from 19/12/2023 to 19/12/2025.
3. The intention to publish date has been changed from 29/08/2025 to 29/08/2026.
4. The Funder Centre for Psychiatry Research (CPF; The Stockholm County Council) was added.
5. Vuxenpsykiatrimottagning Ätstörning Lund was added as a study participating centre
6. The plain English summary has been updated to reflect the changes above.
26/07/2021: Publication reference added.
14/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 09/11/2020 to 09/11/2021.
2. The recruitment end date has been changed from 19/12/2021 to 19/12/2023.
3. The overall trial end date has been changed from 19/12/2021 to 19/12/2023.
4. The intention to publish date has been changed from 29/08/2022 to 29/08/2025.
5. The ethics approval has been updated.
6. The interventions have been updated.
7. The primary outcome measure has been updated.
8. The secondary outcome measures have been updated.
9. The participant inclusion criteria have been updated.
10. The trial participating centres "Ätstörningsenheten Akademiska Sjukhuset" and "StockholmsCentrum för Ätstörningar (SCÄ)" have been updated.
11. The publication and dissemination plan has been updated.
12. The plain English summary has been updated to reflect the changes above.
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.