Anorexia NervosaNCT02883413
Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa
A study testing CRT + Teach the Parent in people with Anorexia Nervosa, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of the current study is to investigate the role of Cognitive Remediation Therapy (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia Nervosa (AN). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- CRT + Teach the Parent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 16 Nov 2017
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent is between 12-18 years of age and living at home, parent or primary caregiver willing to participate in condition they are randomized into
- Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype), or sub threshold AN according to Diagnostic and Statistical Manual-5 criteria
- Consent of all family members who will be participating in treatment
- Adolescent is not currently receiving outpatient treatment for the eating disorder
Who cannot join
- Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, substance dependence, substance abuse, or bi-polar disorder
- caregiver or adolescent with diagnosis of mental retardation, pervasive developmental disorder, or autism spectrum disorder
- Adolescent with a diagnosis of feeding or eating concerns not elsewhere classified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns
- Adolescent with diagnosis of avoidant/restrictive food intake disorder.
- Adolescent or caregiver with acute suicide risk.
- Concurrent psychosocial treatment for another condition
- Adolescent or parent not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Investigation of Cognitive Remediation Therapy as an Inpatient Intervention for Adolescents With Anorexia Nervosa
The purpose of the current study is to investigate the role of Cognitive Remediation Therapy (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom accommodation, and increased behavioral flexibility in adolescents and parents.
Read the detailed description
Anorexia Nervosa (AN) is a severe psychiatric condition; the hallmark features are low body weight and difficulties gaining weight. We are in need of new methods to jump start treatment, while targeting relevant processes in individuals with AN.
Study Design:
This is a randomized controlled trial looking to address these concerns, with a focus on three distinct aims:
- To evaluate the feasibility and acceptability (by patients and staff) of CRT in a medical hospitalization setting.
- Compare the impact of CRT to CRT + Teach the Parent on adolescent treatment engagement post-discharge, rate of weight gain post-discharge, and reduction of symptom accommodation.
- To evaluate cognitive and behavioral flexibility 6 months post-discharge.
Setting/Participants:
Participants will be 60 adolescents with AN or subclinical AN (and their parents). Adolescents will be hospitalized for treatment of AN and intervention will occur on an inpatient basis. Follow-up will be outpatient.
Study Interventions and Measures:
The current study will investigate the impact of intensive CRT (one sessions/day) delivered during in hospital for medical stabilization. Shortly after admission to hospital, adolescents will be randomly assigned to one of the following conditions: Treatment as usual (TAU), CRT+Contact Control (known as "Family Fun Time" or FFT) and CRT + Teach the Parent. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study. Follow-up will continue for 6 months post-discharge.
Description of Investigational Intervention:
CRT is an adjunctive intervention focusing on the development of meta-cognition: Teaching individuals to think about how they think. It involves presenting individuals with a variety of tasks requiring increasingly complex mental abilities. These include sorting tasks where rules change, geometric figures, illusions, reversing sequences of numbers and letters, and finding various routes on a map.
CRT's focus is mainly on process, instead outcome, and has three main goals:
- Improve brain function by exercising and increasing connections in the brain
- Encourage individuals to think about their thinking style
- Encourage individuals and families to spend time away from thinking about the eating disorder
- Conditions
- Anorexia Nervosa
- Being tested
- CRT + Teach the Parent, CRT + Contact Control
- Keywords
- Adolescents, Cognitive Flexibility, Behavioral Flexibility
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT + Teach the ParentBehavioural
Also called CRT+ TtP
CRT sessions will occur for 45-60 minutes every day (excluding weekends) for 6-8 days while adolescents are in hospital. Adolescents will be given homework and asked to practice tasks each day.
CRT + Contact ControlBehavioural
Also called CRT + Family Fun Time, or CRT + FFT
Adolescents will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). Adolescents will be able to choose 2 tasks from a list and be asked to engage in those tasks with their parents.
| Study group | Role | What they receive |
|---|---|---|
| CRT +Teach the Parent | Experimental | The Teach the Parent (TtP) addition to CRT is designed to increase parental understanding of their adolescents' thinking styles. We hypothesize that by doing so, parents will be more likely to challenge eating disorder behaviors and be less likely to accommodate behavioral symptoms of the eating disorder (e.g., make something low-fat for dinner because it will be easier). In this arm, adolescents will explain what they learned during CRT and walk their parents though at least 4 tasks during each TtP session. Parents and child will not be permitted to speak about the eating disorder during these sessions. TtP sessions will occur 3-4 times during hospitalization and will be guided by the adolescent. Receives: Behavioral: CRT + Teach the Parent |
| CRT + Family Fun Time | Active comparator | In order to assess for any non-specific effects of spending non-eating disorder driven time with family, adolescents in the CRT+ Contact Control condition will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). We refer to this condition as CRT + Family Fun Time (CRT+FFT). Adolescents will be asked to complete a series of fun tasks (some standardized, some are choice driven) with their parents. During these sessions, they will not be permitted to discuss CRT or the eating disorder. Receives: Behavioral: CRT + Contact Control |
| Treatment as Usual (TAU) | No intervention | Adolescents in this condition will not receive any additional treatment. They will have a standard hospital stay with all normal contact with health professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent treatment engagement via questionnaire
The Motivational Stages of Change for Adolescents Recovering from an Eating Disorder (MSCARED) is a questionnaire designed to assess readiness to change among individuals with eating disorders. It is administered via interview, discussing motivation, actions that qualify for making changes, and asking what stage of change the patient is in. The patient then checks off those actions they are doing that contribute to their recovery from a provided checklist.
Measured: Baseline to 3 months post baseline
Secondary outcomes (2)
Change in adolescent cognitive flexibility via questionnaire
The Cognitive Flexibility Scale (CFS) is a 12-item self report measure that assesses 3 different components: cognitive flexibility, rigidity and communication flexibility. Scores for each question range from 1-6 (strongly disagree - strongly agree). Scores on cognitive flexibility are positively related to communication flexibility and negatively related to rigidity. Scores on communication flexibility are also negatively related to rigidity.
Measured: Baseline to 6 months post baseline
Change in parental symptom accommodation, via questionnaire
The Accommodation and Enabling Scale for Eating Disorders (AESED) is a 39-item measure that gathers information about the enabling behaviors that family members with a child who has an eating disorder engage in. It contains three subscales: avoidance and modifying routine, meal ritual, and control of the family.
Measured: Baseline to 3 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation
- Responsible party
- Sponsor
- Investigators
- C. Alix Timko, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883413
- Sponsor's protocol ID
- 15-012624
- Status last verified
- Feb 2019
- First submitted
- 2 Aug 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Timko CA, Fitzpatrick KK, Goulazian T, Kirby D, Parks E, Morrow L, Scharko AM, Peebles R. Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility. J Clin Psychol Med Settings. 2020 Jun;27(2):226-234. doi: 10.1007/s10880-020-09704-w.
PubMed 32052249Timko CA, Goulazian TJ, Fitzpatrick KK, Rodriguez D. Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol. Pilot Feasibility Stud. 2018 Jun 25;4:87. doi: 10.1186/s40814-018-0277-5. eCollection 2018.
PubMed 29983992
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Cognitive Remediation Therapy as an Inpatient Intervention for Adolescents With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02883413
- Acronym / sponsor ID
- 15-012624
- Conditions
- Anorexia Nervosa
- Keywords
- Adolescents, Cognitive Flexibility, Behavioral Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation
- Study start
- Aug 2016
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
The purpose of the current study is to investigate the role of Cognitive Remediation Therapy (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom accommodation, and increased behavioral flexibility in adolescents and parents.
Detailed description
Anorexia Nervosa (AN) is a severe psychiatric condition; the hallmark features are low body weight and difficulties gaining weight. We are in need of new methods to jump start treatment, while targeting relevant processes in individuals with AN.
Study Design:
This is a randomized controlled trial looking to address these concerns, with a focus on three distinct aims:
- To evaluate the feasibility and acceptability (by patients and staff) of CRT in a medical hospitalization setting.
- Compare the impact of CRT to CRT + Teach the Parent on adolescent treatment engagement post-discharge, rate of weight gain post-discharge, and reduction of symptom accommodation.
- To evaluate cognitive and behavioral flexibility 6 months post-discharge.
Setting/Participants:
Participants will be 60 adolescents with AN or subclinical AN (and their parents). Adolescents will be hospitalized for treatment of AN and intervention will occur on an inpatient basis. Follow-up will be outpatient.
Study Interventions and Measures:
The current study will investigate the impact of intensive CRT (one sessions/day) delivered during in hospital for medical stabilization. Shortly after admission to hospital, adolescents will be randomly assigned to one of the following conditions: Treatment as usual (TAU), CRT+Contact Control (known as "Family Fun Time" or FFT) and CRT + Teach the Parent. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study. Follow-up will continue for 6 months post-discharge.
Description of Investigational Intervention:
CRT is an adjunctive intervention focusing on the development of meta-cognition: Teaching individuals to think about how they think. It involves presenting individuals with a variety of tasks requiring increasingly complex mental abilities. These include sorting tasks where rules change, geometric figures, illusions, reversing sequences of numbers and letters, and finding various routes on a map.
CRT's focus is mainly on process, instead outcome, and has three main goals:
- Improve brain function by exercising and increasing connections in the brain
- Encourage individuals to think about their thinking style
- Encourage individuals and families to spend time away from thinking about the eating disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRT +Teach the Parent | Experimental | Behavioral: CRT + Teach the ParentThe Teach the Parent (TtP) addition to CRT is designed to increase parental understanding of their adolescents' thinking styles. We hypothesize that by doing so, parents will be more likely to challenge eating disorder behaviors and be less likely to accommodate behavioral symptoms of the eating disorder (e.g., make something low-fat for dinner because it will be easier). In this arm, adolescents will explain what they learned during CRT and walk their parents though at least 4 tasks during each TtP session. Parents and child will not be permitted to speak about the eating disorder during these sessions. TtP sessions will occur 3-4 times during hospitalization and will be guided by the adolescent. |
| CRT + Family Fun Time | Active comparator | Behavioral: CRT + Contact ControlIn order to assess for any non-specific effects of spending non-eating disorder driven time with family, adolescents in the CRT+ Contact Control condition will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). We refer to this condition as CRT + Family Fun Time (CRT+FFT). Adolescents will be asked to complete a series of fun tasks (some standardized, some are choice driven) with their parents. During these sessions, they will not be permitted to discuss CRT or the eating disorder. |
| Treatment as Usual (TAU) | No intervention | –Adolescents in this condition will not receive any additional treatment. They will have a standard hospital stay with all normal contact with health professionals. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent is between 12-18 years of age and living at home, parent or primary caregiver willing to participate in condition they are randomized into
- Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype), or sub threshold AN according to Diagnostic and Statistical Manual-5 criteria
- Consent of all family members who will be participating in treatment
- Adolescent is not currently receiving outpatient treatment for the eating disorder
Key exclusion criteria (7 listed)
- Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, substance dependence, substance abuse, or bi-polar disorder
- caregiver or adolescent with diagnosis of mental retardation, pervasive developmental disorder, or autism spectrum disorder
- Adolescent with a diagnosis of feeding or eating concerns not elsewhere classified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns
- Adolescent with diagnosis of avoidant/restrictive food intake disorder.
- Adolescent or caregiver with acute suicide risk.
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 |
|---|---|---|
| CRT + Teach the ParentAlso: CRT+ TtPCRT sessions will occur for 45-60 minutes every day (excluding weekends) for 6-8 days while adolescents are in hospital. Adolescents will be given homework and asked to practice tasks each day. | Behavioural | CRT +Teach the Parent |
| CRT + Contact ControlAlso: CRT + Family Fun Time, or CRT + FFTAdolescents will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). Adolescents will be able to choose 2 tasks from a list and be asked to engage in those tasks with their parents. | Behavioural | CRT + Family Fun Time |
Primary outcome
Change in adolescent treatment engagement via questionnaire
Time frame: Baseline to 3 months post baseline
The Motivational Stages of Change for Adolescents Recovering from an Eating Disorder (MSCARED) is a questionnaire designed to assess readiness to change among individuals with eating disorders. It is administered via interview, discussing motivation, actions that qualify for making changes, and asking what stage of change the patient is in. The patient then checks off those actions they are doing that contribute to their recovery from a provided checklist.
2 secondary outcomes
Change in adolescent cognitive flexibility via questionnaire
Time frame: Baseline to 6 months post baseline
Change in parental symptom accommodation, via questionnaire
Time frame: Baseline to 3 months post baseline
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 6 Feb 2019.
- Derived from this study: PubMed 32052249Timko CA, Fitzpatrick KK, Goulazian T, Kirby D, Parks E, Morrow L, Scharko AM, Peebles R. Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility. J Clin Psychol Med Settings. 2020 Jun;27(2):226-234. doi: 10.1007/s10880-020-09704-w.
- Derived from this study: PubMed 29983992Timko CA, Goulazian TJ, Fitzpatrick KK, Rodriguez D. Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol. Pilot Feasibility Stud. 2018 Jun 25;4:87. doi: 10.1186/s40814-018-0277-5. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
C. Alix Timko, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT + Teach the Parent in people with Anorexia Nervosa, run by Children's Hospital of Philadelphia at 1 site in United States.
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 7 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in adolescent treatment engagement via questionnaire (time frame: Baseline to 3 months post baseline). 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 NCT02883413, which also lists 2 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 6 Feb 2019.