Body ImageNCT04064255
Evaluation of Practical Body Image Therapy for Anorexia Nervosa V1
A study testing Practical Body Image (session 1 - 7) and Practical Body Image (session 8 - 14) in people with Body Image and Exposure, run by Newbridge House.
Trial summary
Background: Dysfunctional body image is a strong predictor of maintenance and relapse in anorexia nervosa, making treatment of such clinically and financially important. Studies have shown that cognitive behavioural based group therapies and mirror exposure interventions are effective in improving body image in adults… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Body Image, Exposure
- What is being tested?
- Practical Body Image (session 1 - 7) and Practical Body Image (session 8 - 14)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inpatients at Newbridge House
- Aged 11-18
- At or above 90% of minimum healthy weight
- Primary diagnosis of Anorexia Nervosa
Who cannot join
- Previously received treatment at Newbridge House (readmission)
- Patients with a primary diagnosis other than Anorexia Nervosa
- Aged under 11 years
- Any patients with severe learning difficulty
- Active psychosis
About this study
Official title: A Pilot Study Evaluating Practical Body Image (PBI): A Body Image Therapy With Mirror Exposure for Adolescent Inpatients With Anorexia Nervosa
Background:
Dysfunctional body image is a strong predictor of maintenance and relapse in anorexia nervosa, making treatment of such clinically and financially important. Studies have shown that cognitive behavioural based group therapies and mirror exposure interventions are effective in improving body image in adults with eating disorders; however research into individual body image treatments for adolescents with anorexia nervosa is limited.
Read more
Practical Body Image (PBI) is a novel, manualised, individual treatment designed for adolescents with anorexia nervosa for which the evidence base is not yet established. This research will therefore contribute to the evidence base for the treatment of body image in adolescents with anorexia nervosa and inform the effectiveness of a new treatment. The research will be funded by Newbridge House, an inpatient unit for children and adolescents with eating disorders.
Research Questions:
Does Practical Body Image improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa?
Does a mirror exposure intervention improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of the programme?
Design:
Patients aged 11-18, fulfilling DSM-V criteria for anorexia nervosa and receiving treatment at Newbridge House will be recruited for participation in the research study. Participants will be randomly allocated to either a case or control group. Allocation will be based on a non-blind randomised controlled trial. Cases will receive PBI in addition to treatment as usual and will be compared with controls who just receive treatment as usual. Both groups will complete a set of questionnaires at baseline, 7 weeks and 10 weeks.
Read the detailed description
PRINCIPAL NULL HYPOTHESIS PBI will have no impact on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.
SECONDARY NULL HYPOTHESIS Mirror exposure will have no effect on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.
PRINCIPAL ALTERNATIVE HYPOTHESIS PBI will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.
SECONDARY ALTERNATIVE HYPOTHESIS Mirror exposure will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.
The alternative hypotheses were chosen based previous research which shows that cognitive behavioural techniques and mirror exposure are effective in improving body image disturbance and psychological wellbeing in adults with anorexia nervosa. This study aims to generate hypotheses about which specific elements of body image (i.e. body avoidance, body acceptance, body anxiety or weight and shape concern) and psychological wellbeing (i.e. self esteem, anxiety and depression) change after completion of PBI.
DESIGN
The principal hypothesis will be tested using a between subjects design (PBI vs no PBI) with treatment as the independent variable. The case group will receive TAU as well as PBI and the control group will receive just TAU. The outcomes from self-report measures completed at 10 weeks will be compared between the case and control groups to answer the principal research question.
The secondary hypothesis will be tested using a within subjects design (before mirror exposure vs after mirror exposure) with mirror exposure as the independent variable. The case group will complete self-report measures at week 7 before commencing mirror exposure in addition to week 10. This will allow comparison of outcomes before mirror exposure to after mirror exposure to answer the secondary research question.
The dependent variables are body image (including body avoidance, acceptance, anxiety and weight and shape concerns) and psychological wellbeing (including self-esteem, anxiety and depression) as measured by self-report questionnaires.
This experimental design has been chosen as it allows for the comparison of PBI vs no PBI as well as a comparison between outcomes before mirror exposure and outcomes after mirror exposure. The choice of this design was influenced by a desire to provide an evidence base for this novel treatment and to determine whether mirror exposure has any additional benefit for adolescents with anorexia nervosa.
METHOD
Participants will be inpatients, aged 11 - 18, fulfilling DSM-IV criteria for anorexia nervosa and receiving treatment at Newbridge House child and adolescent inpatient eating disorder unit. A convenience sampling method will be used and participants will be randomly allocated to either a 'case' group to complete TAU plus PBI or a 'control' group to complete only TAU using an Excel formula. A control group (TAU) was included in order to compare outcomes of those who complete PBI with outcomes of those who do not. This is because the principal aim of the study is to evaluate the effectiveness of this novel treatment and there is insufficient evidence to support the introduction of PBI without conducting a study of this kind. This is especially necessary given that the research site is an inpatient unit and all participants will be receiving other therapies alongside the treatment being tested.
Forty participants will be recruited in total (twenty in each group). As this is a pilot study no power calculation could be conducted and this sample size was agreed as sufficient to generate data to inform a power calculation for future research. Participants will be identifiable by a unique code created using the letters 'TAU+PBI' or 'TAU' followed by a number relating to the order in which they were recruited (1-20). Participants will be approached to take part in the research when they reach 90% of their healthy weight. All patients on the unit who fulfill the framework of inclusion and exclusion criteria will be asked for their informed written consent to participate after reading a research information sheet. For patients under age 16, parents will also be given a research information sheet and consent form and asked to provide written informed consent.
TIMETABLE
All stages will take place on site at Newbridge House.
STAGE 0 (Recruitment)
Patients will be recruited as described above and an Assistant Psychologist will meet with them to read through the research information sheet and request informed written consent. For patients under 16, written parental consent will also be sought and parents will be given an information sheet and consent form prior to commencement of the study. Patients and parents will be given 7 days to consider their decision to consent to participate in the research. Patients for whom we receive consent will then be randomly allocated to either the case or control group using an Excel formula. Patients who do not consent, or for whom parental consent is not received, will not be included in the study and will receive TAU which will be identical to that delivered to controls. Patients declining to participate will be asked for permission to use demographic and routine clinical data to test if there are any significant differences between participants versus non-participants, and to examine whether the sample is representative.
Stage 1 (Week 1)
All participants will be asked to complete a set of self-report measures in week 1 (baseline). For participants in the case group, PBI will then commence and take place over 7 weeks alongside TAU. For participants in the control group TAU will continue.
STAGE 2 (Week 7)
Stage 2 will take place 7 weeks after completion of baseline measures in between session 7 and 8 of PBI. At this stage the same measures will be completed by participants in the case group only.
For participants in the case group, the mirror exposure part of PBI will commence and take place twice a week, over 3 weeks alongside TAU. For participants in the control group TAU will continue.
STAGE 3 (Week 10)
Stage 3 will take place 10 weeks after completion of baseline measures. At this stage those in the case group will have completed the PBI intervention. The same measures will be completed for the last time by participants in both the case and control groups.
Participant feedback about their experiences of the programme will also be sought.
STAGE 4 (Data analysis)
Researchers will input raw data from completed outcome measures onto an SPSS spreadsheet. Data will then be analysed and interpreted.
STAGE 5 (Report write up)
The final report will be written for publication.
INTERVENTION The intervention will comprise of 14 sessions of individual body image therapy using a cognitive behavioural approach over a 10 week period. The therapy has been protocolised into a treatment manual known as PBI, and will be administered by Assistant Psychologists employed at Newbridge House receiving weekly supervision from a Clinical Psychologist.
PBI is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 6 weekly sessions followed by 8 twice weekly sessions over 4 weeks. Therapists delivering the programme will have time to read through the manual and attend weekly peer supervision to support adherence to the protocol. Therapists will require some background knowledge of the nature of body image in eating disorders and some knowledge of basic CBT principles. They will also receive weekly clinical supervision by a trained CBT therapist. The sessions are structured and laid out in the following overview:
Week 1, Session 1: My Body Image
Week 2, Session 2: Body Perception
Week 3, Session 3: Testing Beliefs
Week 4, Session 4: Body Avoidance Outing 1
Week 5, Session 5: Body Avoidance Outing 2
Week 6, Session 6: Review and Reflection
Week 7, Session 7: Introduction to Mirror Use Session 8: Mirror Exposure 1
Week 8, Session 9: Mirror Exposure 2 Session 10: Mirror Exposure 3
Week 9, Session 11: Mirror Exposure 4 Session 12: Mirror Exposure 5
Week 10,Session 13: Mirror Exposure 6 Session 14: Ending Session
Week 10, Session 13: Mirror Exposure, Session 14: Ending session
- Conditions
- Body Image, Exposure
- Being tested
- Practical Body Image (session 1 - 7), Practical Body Image (session 8 - 14)
- Keywords
- Body Image, Anorexia Nervosa, Adolescents, Mirror exposure
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practical Body Image (session 1 - 7)Other
Practical body image therapy
Practical Body Image (session 8 - 14)Other
Twice weekly mirror exposure plus ending session
| Study group | Role | What they receive |
|---|---|---|
| Case: Practical Body Image + Treatment as Usual | Active comparator | The Case arm involves Practical Body Image + treatment as usual.
Practical Body Image is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 10 weeks (6 weekly sessions over 6 weeks, followed by 8 twice weekly sessions over 4 weeks).
Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist. Receives: Other: Practical Body Image (session 1 - 7); Other: Practical Body Image (session 8 - 14) |
| Control: Treatment as Usual Only | No intervention | Control arm involves treatment as usual only. Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image Acceptance and Action Questionnaire
A validated self-report measure assessing change in cognitive flexibility and acceptance relatively to body image. The measure consists of 12 questions.
Measured: Assessed at baseline, 7 weeks and 10 weeks.
Secondary outcomes (4)
Youth Eating Disorder Examination Questionnaire
This is the youth version of the EDE-Q which is a validated self-report measure assessing change in eating disorder psychopathology using four sub-scales measuring weight concern, shape concern, dietary restraint and eating concern. The measure consists of 39 questions.
Measured: Assessed at baseline, 7 weeks and 10 weeks.
Body Image Avoidance Questionnaire
A validated self-report measure assessing change in body image avoidance divided into three sub-scales including social avoidance, clothing avoidance and personal grooming. The measure consists of 12 questions.
Measured: Assessed at baseline, 7 weeks and 10 weeks.
Physical Appearance State and Trait Anxiety Scale: Trait Version
A validated self-report measure assessing change in trait anxiety relating to physical appearance. The measure consists of 16 questions.
Measured: Assessed at baseline, 7 weeks and 10 weeks.
Healthy weight body acceptance scale
A non validated self-report measure assessing change in what having a healthy weight body means to a person, acceptance of having a healthy weight body and the motivation and confidence to accept having a healthy weight body. The measure consists of 4 questions.
Measured: Assessed at baseline, 7 weeks and 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study startSep 2016
- Primary completionJul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newbridge House
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Morgan, Leeds and York Partnership NHS Foundation Trust
- Investigators
- John F Morgan, Medicine, Principal investigator, Yorkshire Centre for Eating Disorders, Leeds and York NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064255
- Sponsor's protocol ID
- NBPBI1992
- Status last verified
- Aug 2019
- First submitted
- 23 Jun 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stice E. Risk and maintenance factors for eating pathology: a meta-analytic review. Psychol Bull. 2002 Sep;128(5):825-48. doi: 10.1037/0033-2909.128.5.825.
PubMed 12206196Fairburn CG, Peveler RC, Jones R, Hope RA, Doll HA. Predictors of 12-month outcome in bulimia nervosa and the influence of attitudes to shape and weight. J Consult Clin Psychol. 1993 Aug;61(4):696-8. doi: 10.1037//0022-006x.61.4.696.
PubMed 8370866Keel PK, Dorer DJ, Franko DL, Jackson SC, Herzog DB. Postremission predictors of relapse in women with eating disorders. Am J Psychiatry. 2005 Dec;162(12):2263-8. doi: 10.1176/appi.ajp.162.12.2263.
PubMed 16330589Morgan JF, Lazarova S, Schelhase M, Saeidi S. Ten session body image therapy: efficacy of a manualised body image therapy. Eur Eat Disord Rev. 2014 Jan;22(1):66-71. doi: 10.1002/erv.2249. Epub 2013 Sep 5.
PubMed 24006359Key A, George CL, Beattie D, Stammers K, Lacey H, Waller G. Body image treatment within an inpatient program for anorexia nervosa: the role of mirror exposure in the desensitization process. Int J Eat Disord. 2002 Mar;31(2):185-90. doi: 10.1002/eat.10027.
PubMed 11920979Legenbauer T, Schutt-Stromel S, Hiller W, Vocks S. Predictors of improved eating behaviour following body image therapy: a pilot study. Eur Eat Disord Rev. 2011 Mar-Apr;19(2):129-37. doi: 10.1002/erv.1017.
PubMed 25363718Nye S, Cash TF. Outcomes of manualized cognitive-behavioral body image therapy with eating disordered women treated in a private clinical practice. Eat Disord. 2006 Jan-Feb;14(1):31-40. doi: 10.1080/10640260500403840.
PubMed 16757447Delinsky SS, Wilson GT. Mirror exposure for the treatment of body image disturbance. Int J Eat Disord. 2006 Mar;39(2):108-16. doi: 10.1002/eat.20207.
PubMed 16231342
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Practical Body Image (PBI): A Body Image Therapy With Mirror Exposure for Adolescent Inpatients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04064255
- Acronym / sponsor ID
- NBPBI1992
- Conditions
- Body Image, Exposure
- Keywords
- Body Image, Anorexia Nervosa, Adolescents, Mirror exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Newbridge HouseUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Dysfunctional body image is a strong predictor of maintenance and relapse in anorexia nervosa, making treatment of such clinically and financially important. Studies have shown that cognitive behavioural based group therapies and mirror exposure interventions are effective in improving body image in adults with eating disorders; however research into individual body image treatments for adolescents with anorexia nervosa is limited.
Practical Body Image (PBI) is a novel, manualised, individual treatment designed for adolescents with anorexia nervosa for which the evidence base is not yet established. This research will therefore contribute to the evidence base for the treatment of body image in adolescents with anorexia nervosa and inform the effectiveness of a new treatment. The research will be funded by Newbridge House, an inpatient unit for children and adolescents with eating disorders.
Research Questions:
Does Practical Body Image improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa?
Does a mirror exposure intervention improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of the programme?
Design:
Patients aged 11-18, fulfilling DSM-V criteria for anorexia nervosa and receiving treatment at Newbridge House will be recruited for participation in the research study. Participants will be randomly allocated to either a case or control group. Allocation will be based on a non-blind randomised controlled trial. Cases will receive PBI in addition to treatment as usual and will be compared with controls who just receive treatment as usual. Both groups will complete a set of questionnaires at baseline, 7 weeks and 10 weeks.
Detailed description
PRINCIPAL NULL HYPOTHESIS PBI will have no impact on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.
SECONDARY NULL HYPOTHESIS Mirror exposure will have no effect on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.
PRINCIPAL ALTERNATIVE HYPOTHESIS PBI will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.
SECONDARY ALTERNATIVE HYPOTHESIS Mirror exposure will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.
The alternative hypotheses were chosen based previous research which shows that cognitive behavioural techniques and mirror exposure are effective in improving body image disturbance and psychological wellbeing in adults with anorexia nervosa. This study aims to generate hypotheses about which specific elements of body image (i.e. body avoidance, body acceptance, body anxiety or weight and shape concern) and psychological wellbeing (i.e. self esteem, anxiety and depression) change after completion of PBI.
DESIGN
The principal hypothesis will be tested using a between subjects design (PBI vs no PBI) with treatment as the independent variable. The case group will receive TAU as well as PBI and the control group will receive just TAU. The outcomes from self-report measures completed at 10 weeks will be compared between the case and control groups to answer the principal research question.
The secondary hypothesis will be tested using a within subjects design (before mirror exposure vs after mirror exposure) with mirror exposure as the independent variable. The case group will complete self-report measures at week 7 before commencing mirror exposure in addition to week 10. This will allow comparison of outcomes before mirror exposure to after mirror exposure to answer the secondary research question.
The dependent variables are body image (including body avoidance, acceptance, anxiety and weight and shape concerns) and psychological wellbeing (including self-esteem, anxiety and depression) as measured by self-report questionnaires.
This experimental design has been chosen as it allows for the comparison of PBI vs no PBI as well as a comparison between outcomes before mirror exposure and outcomes after mirror exposure. The choice of this design was influenced by a desire to provide an evidence base for this novel treatment and to determine whether mirror exposure has any additional benefit for adolescents with anorexia nervosa.
METHOD
Participants will be inpatients, aged 11 - 18, fulfilling DSM-IV criteria for anorexia nervosa and receiving treatment at Newbridge House child and adolescent inpatient eating disorder unit. A convenience sampling method will be used and participants will be randomly allocated to either a 'case' group to complete TAU plus PBI or a 'control' group to complete only TAU using an Excel formula. A control group (TAU) was included in order to compare outcomes of those who complete PBI with outcomes of those who do not. This is because the principal aim of the study is to evaluate the effectiveness of this novel treatment and there is insufficient evidence to support the introduction of PBI without conducting a study of this kind. This is especially necessary given that the research site is an inpatient unit and all participants will be receiving other therapies alongside the treatment being tested.
Forty participants will be recruited in total (twenty in each group). As this is a pilot study no power calculation could be conducted and this sample size was agreed as sufficient to generate data to inform a power calculation for future research. Participants will be identifiable by a unique code created using the letters 'TAU+PBI' or 'TAU' followed by a number relating to the order in which they were recruited (1-20). Participants will be approached to take part in the research when they reach 90% of their healthy weight. All patients on the unit who fulfill the framework of inclusion and exclusion criteria will be asked for their informed written consent to participate after reading a research information sheet. For patients under age 16, parents will also be given a research information sheet and consent form and asked to provide written informed consent.
TIMETABLE
All stages will take place on site at Newbridge House.
STAGE 0 (Recruitment)
Patients will be recruited as described above and an Assistant Psychologist will meet with them to read through the research information sheet and request informed written consent. For patients under 16, written parental consent will also be sought and parents will be given an information sheet and consent form prior to commencement of the study. Patients and parents will be given 7 days to consider their decision to consent to participate in the research. Patients for whom we receive consent will then be randomly allocated to either the case or control group using an Excel formula. Patients who do not consent, or for whom parental consent is not received, will not be included in the study and will receive TAU which will be identical to that delivered to controls. Patients declining to participate will be asked for permission to use demographic and routine clinical data to test if there are any significant differences between participants versus non-participants, and to examine whether the sample is representative.
Stage 1 (Week 1)
All participants will be asked to complete a set of self-report measures in week 1 (baseline). For participants in the case group, PBI will then commence and take place over 7 weeks alongside TAU. For participants in the control group TAU will continue.
STAGE 2 (Week 7)
Stage 2 will take place 7 weeks after completion of baseline measures in between session 7 and 8 of PBI. At this stage the same measures will be completed by participants in the case group only.
For participants in the case group, the mirror exposure part of PBI will commence and take place twice a week, over 3 weeks alongside TAU. For participants in the control group TAU will continue.
STAGE 3 (Week 10)
Stage 3 will take place 10 weeks after completion of baseline measures. At this stage those in the case group will have completed the PBI intervention. The same measures will be completed for the last time by participants in both the case and control groups.
Participant feedback about their experiences of the programme will also be sought.
STAGE 4 (Data analysis)
Researchers will input raw data from completed outcome measures onto an SPSS spreadsheet. Data will then be analysed and interpreted.
STAGE 5 (Report write up)
The final report will be written for publication.
INTERVENTION The intervention will comprise of 14 sessions of individual body image therapy using a cognitive behavioural approach over a 10 week period. The therapy has been protocolised into a treatment manual known as PBI, and will be administered by Assistant Psychologists employed at Newbridge House receiving weekly supervision from a Clinical Psychologist.
PBI is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 6 weekly sessions followed by 8 twice weekly sessions over 4 weeks. Therapists delivering the programme will have time to read through the manual and attend weekly peer supervision to support adherence to the protocol. Therapists will require some background knowledge of the nature of body image in eating disorders and some knowledge of basic CBT principles. They will also receive weekly clinical supervision by a trained CBT therapist. The sessions are structured and laid out in the following overview:
Week 1, Session 1: My Body Image
Week 2, Session 2: Body Perception
Week 3, Session 3: Testing Beliefs
Week 4, Session 4: Body Avoidance Outing 1
Week 5, Session 5: Body Avoidance Outing 2
Week 6, Session 6: Review and Reflection
Week 7, Session 7: Introduction to Mirror Use Session 8: Mirror Exposure 1
Week 8, Session 9: Mirror Exposure 2 Session 10: Mirror Exposure 3
Week 9, Session 11: Mirror Exposure 4 Session 12: Mirror Exposure 5
Week 10,Session 13: Mirror Exposure 6 Session 14: Ending Session
Week 10, Session 13: Mirror Exposure, Session 14: Ending session
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: Practical Body Image + Treatment as Usual | Active comparator | Other: Practical Body Image (session 1 - 7), Other: Practical Body Image (session 8 - 14)The Case arm involves Practical Body Image + treatment as usual. Practical Body Image is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 10 weeks (6 weekly sessions over 6 weeks, followed by 8 twice weekly sessions over 4 weeks). Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist. |
| Control: Treatment as Usual Only | No intervention | –Control arm involves treatment as usual only. Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Inpatients at Newbridge House
- Aged 11-18
- At or above 90% of minimum healthy weight
- Primary diagnosis of Anorexia Nervosa
Key exclusion criteria (5 listed)
- Previously received treatment at Newbridge House (readmission)
- Patients with a primary diagnosis other than Anorexia Nervosa
- Aged under 11 years
- Any patients with severe learning difficulty
- Active psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practical Body Image (session 1 - 7)Practical body image therapy | Other | Case: Practical Body Image + Treatment as Usual |
| Practical Body Image (session 8 - 14)Twice weekly mirror exposure plus ending session | Other | Case: Practical Body Image + Treatment as Usual |
Primary outcome
Body Image Acceptance and Action Questionnaire
Time frame: Assessed at baseline, 7 weeks and 10 weeks.
A validated self-report measure assessing change in cognitive flexibility and acceptance relatively to body image. The measure consists of 12 questions.
4 secondary outcomes
Youth Eating Disorder Examination Questionnaire
Time frame: Assessed at baseline, 7 weeks and 10 weeks.
Body Image Avoidance Questionnaire
Time frame: Assessed at baseline, 7 weeks and 10 weeks.
Physical Appearance State and Trait Anxiety Scale: Trait Version
Time frame: Assessed at baseline, 7 weeks and 10 weeks.
Healthy weight body acceptance scale
Time frame: Assessed at baseline, 7 weeks and 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 12206196Stice E. Risk and maintenance factors for eating pathology: a meta-analytic review. Psychol Bull. 2002 Sep;128(5):825-48. doi: 10.1037/0033-2909.128.5.825.
- Background: PubMed 8370866Fairburn CG, Peveler RC, Jones R, Hope RA, Doll HA. Predictors of 12-month outcome in bulimia nervosa and the influence of attitudes to shape and weight. J Consult Clin Psychol. 1993 Aug;61(4):696-8. doi: 10.1037//0022-006x.61.4.696.
- Background: PubMed 16330589Keel PK, Dorer DJ, Franko DL, Jackson SC, Herzog DB. Postremission predictors of relapse in women with eating disorders. Am J Psychiatry. 2005 Dec;162(12):2263-8. doi: 10.1176/appi.ajp.162.12.2263.
- Background: PubMed 24006359Morgan JF, Lazarova S, Schelhase M, Saeidi S. Ten session body image therapy: efficacy of a manualised body image therapy. Eur Eat Disord Rev. 2014 Jan;22(1):66-71. doi: 10.1002/erv.2249. Epub 2013 Sep 5.
- Background: PubMed 11920979Key A, George CL, Beattie D, Stammers K, Lacey H, Waller G. Body image treatment within an inpatient program for anorexia nervosa: the role of mirror exposure in the desensitization process. Int J Eat Disord. 2002 Mar;31(2):185-90. doi: 10.1002/eat.10027.
- Background: PubMed 25363718Legenbauer T, Schutt-Stromel S, Hiller W, Vocks S. Predictors of improved eating behaviour following body image therapy: a pilot study. Eur Eat Disord Rev. 2011 Mar-Apr;19(2):129-37. doi: 10.1002/erv.1017.
- Background: PubMed 16757447Nye S, Cash TF. Outcomes of manualized cognitive-behavioral body image therapy with eating disordered women treated in a private clinical practice. Eat Disord. 2006 Jan-Feb;14(1):31-40. doi: 10.1080/10640260500403840.
- Background: PubMed 16231342Delinsky SS, Wilson GT. Mirror exposure for the treatment of body image disturbance. Int J Eat Disord. 2006 Mar;39(2):108-16. doi: 10.1002/eat.20207.
- Individual participant dataSharing planned: No
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Not yet recruiting
Expand Your Horizon-Spanish
Body Image, Body Image Dissatisfaction
Recruiting
Evaluation of a Brief Influencer-Delivered Body Image Video
Body Image
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Morgan, Medicine principal investigator
Yorkshire Centre for Eating Disorders, Leeds and York NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Practical Body Image (session 1 - 7) and Practical Body Image (session 8 - 14) in people with Body Image and Exposure, run by Newbridge House.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Image Acceptance and Action Questionnaire (time frame: Assessed at baseline, 7 weeks and 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064255, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.