Cognitive Remediation Therapy for Anorexia

Overseen By Samantha L Turner, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must not be taking: Antipsychotics

Disqualifiers: Pervasive developmental disability, psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Cognitive Remediation Therapy (a therapy focused on enhancing cognitive skills) with Family Based Treatment can help adolescents with anorexia improve their ability to switch thoughts or tasks easily, potentially leading to better overall outcomes. The trial includes two groups: one receives both therapies, while the other receives only Family Based Treatment. Adolescents aged 12-18 with a current diagnosis of anorexia who are medically stable for outpatient treatment, along with a willing parent or caregiver, are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative therapy combinations that could enhance treatment outcomes for adolescents with anorexia.

Will I have to stop taking my current medications?

The trial requires that adolescents do not use anti-psychotic medication during the first 15 sessions of family-based therapy (FBT). However, this medication is allowed during the optional 12 FBT sessions in the 6-month follow-up period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Remediation Therapy (CRT) is generally safe for people with anorexia. Studies have demonstrated that CRT helps participants adapt to new situations without significant side effects. Participants improved in thinking and information processing, with no major negative effects reported.

Family Based Treatment (FBT), also included in this trial, is a well-known therapy for anorexia and is usually considered safe. It involves the family in the treatment process. Both CRT and FBT aim to improve mental and emotional health, and research suggests they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Remediation Therapy (CRT) combined with Family Based Treatment (FBT) for anorexia because it introduces a cognitive-focused approach to enhance traditional methods. Unlike standard treatments that primarily focus on nutritional rehabilitation and family involvement, this combination targets cognitive flexibility and processing speed in adolescents, addressing underlying cognitive deficits associated with anorexia. The addition of CRT before the FBT sessions aims to prepare the adolescent mentally, potentially making the family therapy more effective. This innovative approach could lead to more comprehensive treatment outcomes, addressing both cognitive and behavioral aspects of anorexia.

What evidence suggests that this trial's treatments could be effective for anorexia?

Research has shown that Cognitive Remediation Therapy (CRT) can help people with anorexia become more flexible in their thinking, potentially making it easier for them to adapt their thoughts and actions in new situations. Some studies have found that CRT aids in understanding how individuals process information. However, one study found that CRT did not enhance abstract thinking skills more than standard therapies. In this trial, one group will receive Family Based Treatment (FBT) with Adolescent-focused CRT, while another group will receive FBT alone. Overall, CRT may offer some benefits, particularly in helping individuals adhere to their treatment programs. ^{6 7 8 9 10}

Who Is on the Research Team?

Catherine Alix Timko, PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with Anorexia Nervosa who are stable enough for outpatient treatment and have no other major health issues. Parents or caregivers must be over 18, willing to participate, live with the adolescent, and provide medical clearance.

Inclusion Criteria

Fluent in English

Medical clearance from primary care physician and permission to speak to Primary Care Physician about clinical issues

Parent or caregiver willing to participate

Exclusion Criteria

I am a pregnant teenager.

I can use anti-psychotic medication during the later part of the study.

Presence of pervasive developmental disability, psychosis, bipolar disorder, substance abuse, autism spectrum disorder, or intellectual disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Family Based Treatment (FBT) with or without Adolescent-focused Cognitive Remediation Therapy (CRT) over 15 sessions

6 months

15 sessions

Follow-up

Participants are monitored for changes in executive functioning, weight gain, and eating disorder symptomatology

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Remediation Therapy
• Family Based Treatment

Trial Overview The study tests if Cognitive Remediation Therapy (CRT) can improve 'set-shifting' (the ability to switch between tasks or thoughts) in teens with Anorexia Nervosa, potentially leading to better outcomes when combined with Family Based Treatment.

How Is the Trial Designed?

Group I: FBT w/ Adolescent-focused Cognitive Remediation Therapy Experimental Treatment 2 Interventions

Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of FBT over six months. The first 9 sessions of FBT will be preceded by adolescent-focused CRT.

Group II: Family Based Treatment (FBT) Active Control 1 Intervention

Families will receive 15 sessions of FBT alone.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10886621/

The Efficacy of Cognitive Remediation Therapy for Anorexia ... Results: Findings suggest that CRT can help people increase their awareness of cognitive styles and information processing and have a positive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11557350/

Effect of cognitive remediation therapy in anorexia nervosa CRT did not show a statistically significant difference compared to the control group in improving abstract thinking skills and quality of life in individuals ...

3. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-014-0026-y

A systematic review of cognitive remediation therapy for ... For patients receiving CRT, results revealed lower dropout rates compared to the CBT group (13 and 33% respectively), as well as significant ...

4. policylab.chop.edu policylab.chop.edu/project/enhancing-outcomes-adolescent-anorexia-nervosa-cognitive-remediation-therapy

Enhancing Outcomes in Adolescent Anorexia Nervosa with ... Cognitive Remediation Therapy (CRT) is a treatment known to improve cognitive flexibility. CRT focuses on the development of meta-cognition, or teaching ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421000495

Cognitive remediation therapy as an adjunctive treatment ... This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489286/

The Shifting Perspectives Study Protocol: Cognitive ... This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01772394

Cognitive Remediation Therapy in Anorexia Nervosa ... CRT is a 10-sessions long program that has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12470611/

The CORTEX Project: A Pre–Post Randomized Controlled ... The study will test the feasibility and efficacy of CA-CRT in enhancing selected neuropsychological outcomes (cognitive flexibility and central ...

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2018.00096/full

Impact of Cognitive Remediation Therapy on ... Results: Participants showed significant improvement in task-based measures of neurocognition following CRT. There were no significant changes in self-report ...

10. mdpi.com mdpi.com/2076-3425/14/2/118

The Efficacy of Cognitive Remediation Therapy for ... Results: Findings suggest that CRT can help people increase their awareness of cognitive styles and information processing and have a positive ...