Attention Bias Modification for Anxiety in Childhood Cancer Survivors

Overseen By Nancy Lau, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Active cancer treatment, Cognitive impairment, No technology, others

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Attention Bias Modification (ABM) to reduce anxiety in adolescent and young adult cancer survivors. Anxiety commonly affects these survivors and can lead to depression and sleep issues. ABM involves short, self-guided smartphone tasks to alter reactions to stressors and includes activities to enhance positive emotions. Participants will use either the ABM app or a similar task for four weeks. The trial seeks cancer survivors aged 15-29 who have completed treatment and have smartphone access. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mental health support for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Attention Bias Modification is safe for adolescent and young adult cancer survivors?

Research has shown that Attention Bias Modification (ABM) safely helps manage anxiety. In past studies, participants, including children and teens, handled ABM well, with no major reports of harmful side effects. This treatment uses a smartphone app to change reactions to anxiety-inducing stimuli. Participants complete tasks that encourage focus on neutral or positive things instead of negative ones. This method has lowered anxiety symptoms without causing discomfort or adverse effects. Overall, ABM appears to be a safe choice for managing anxiety, even for teens and young adults who have survived cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Attention Bias Modification (ABM) for anxiety in childhood cancer survivors because it offers a novel approach compared to traditional therapies like cognitive-behavioral therapy or medication. ABM specifically targets the way attention is directed, helping patients shift focus away from anxiety-triggering stimuli. Unlike conventional methods that often require longer duration to see results, ABM sessions are brief and supplemented by engaging daily text prompts, potentially leading to quicker and more sustainable improvements in managing anxiety. The use of technology in the form of text messaging also makes this method accessible and easy to integrate into daily life, offering a modern twist to anxiety management.

What evidence suggests that Attention Bias Modification is effective for anxiety in childhood cancer survivors?

Research has shown that Attention Bias Modification (ABM), which participants in this trial may receive, can help reduce anxiety symptoms. Studies have found that children who participated in ABM often experienced a significant reduction in anxiety, with many no longer having an anxiety disorder. ABM helps individuals change their automatic reactions to stress by shifting focus away from threats and towards more neutral or positive thoughts. Using smartphone apps, ABM includes activities like identifying things to be grateful for, which can increase positive feelings. This method aims to improve anxiety symptoms in adolescents and young adults who have survived cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Nancy Lau, PhD

Principal Investigator

Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult cancer survivors who have experienced anxiety after battling childhood cancer, head and neck cancers, or leukemia. Participants should be comfortable using internet-based applications and willing to engage in interviews and questionnaires.

Inclusion Criteria

I am between 15 and 29 years old.

I have been diagnosed with cancer.

I received cancer treatment aimed at curing me at a specified hospital.

Exclusion Criteria

Patients who cannot understand/read/write English will be excluded from the research because the ABM intervention is currently only available in English

I am unable to take part in specific activities or answer surveys due to physical or cognitive reasons.

I am currently receiving treatment aimed at curing my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in ABM or inert attention task sessions over 10 minutes twice a week and respond daily to text messaging prompts for 4 weeks

4 weeks

8 sessions (virtual), daily text prompts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up survey (virtual)

Open-label extension (optional)

Participants are given access to all components of ABM and texts on study after completion of the follow-up survey

What Are the Treatments Tested in This Trial?

Interventions

• Attention Bias Modification

Trial Overview

The study tests if attention bias modification (ABM) via smartphone apps can reduce anxiety by redirecting focus from negative triggers to neutral or positive stimuli. It includes gratitude exercises and aims to improve the mental health of young cancer survivors.

How Is the Trial Designed?

Group I: Arm I (ABM) Experimental Treatment 4 Interventions

Patients engage in ABM over 10 minutes BIW and respond daily to text messaging prompts for 4 weeks.

Group II: Arm II (inert attention task) Active Control 3 Interventions

Patients engage in inert attention task sessions over 10 minutes BIW for 4 weeks. Patients also receive and respond to text messaging prompts QD for 4 weeks. After completion of the 4 week follow up survey, patients are given access to all components of ABM and texts on study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving anxious youth, adding Attention Bias Modification Treatment (ABMT) to 8 weeks of cognitive-behavioral therapy (CBT) did not enhance clinician-rated outcomes, but it did lead to earlier reductions in self-reported anxiety compared to CBT alone.

The research also showed that neural responses related to attention bias were stable in healthy youth, indicating that understanding these stable patterns could inform future ABMT strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training-associated changes and stability of attention bias in youth: Implications for Attention Bias Modification Treatment for pediatric anxiety. Britton, JC., Bar-Haim, Y., Clementi, MA., et al.[2021]

Long-term survivors of childhood acute lymphoblastic leukemia (ALL) who received cranial radiation therapy (CRT) showed significant attention deficits, particularly in shifting focus between local and global stimuli, compared to peers without a history of ALL.

Participants treated with only chemotherapy performed similarly to the non-ALL group, indicating that CRT is primarily responsible for the observed attention issues in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual attention in long-term survivors of leukemia receiving cranial radiation therapy. Schatz, J., Kramer, JH., Ablin, AR., et al.[2007]

A randomized controlled trial involving 53 youths with concerning anxiety levels showed that both attention bias modification treatment (ABMT) and attention control training (ACT) significantly reduced anxiety severity and global impairment after treatment and at a 2-month follow-up.

ACT was found to be more effective than ABMT in reducing anxiety severity at follow-up, suggesting that attention control may play a crucial role in improving anxiety outcomes in youths, highlighting the need for further research on the mechanisms of attention training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention Training as a Low-Intensity Treatment for Concerning Anxiety in Clinic-Referred Youth. Pettit, JW., Rey, Y., Marin, CE., et al.[2023]

In a double-blind, randomized controlled trial involving 31 children with anxiety disorders, attention bias modification (ABM) training significantly increased the number of treatment responders compared to a control condition.

The ABM group also showed a greater reduction in anxiety severity, suggesting that this intervention may be effective in helping children manage anxiety, although further research is needed to understand how it works.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Attention Bias Training for Child Anxiety Disorders: A Randomized Controlled Trial. Chang, SW., Kuckertz, JM., Bose, D., et al.[2020]

A four-week attention modification program (AMP) was tested on 16 children and adolescents (ages 10 to 17) with clinical anxiety, resulting in significant reductions in anxiety and depression symptoms, with 12 out of 16 participants no longer meeting criteria for any anxiety diagnosis after treatment.

The AMP was found to be feasible and acceptable for both youths and their parents, suggesting it could be a promising intervention for addressing anxiety in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of attention modification in clinically anxious youths. Rozenman, M., Weersing, VR., Amir, N.[2021]

Women with persistent anxiety after breast cancer showed attentional bias away from cancer-related information and negatively valenced words, indicating a tendency to avoid potential threats, unlike healthy controls who focused more on these stimuli.

The study found that women with high anxiety after breast cancer had a significantly greater negative interpretation bias compared to healthy controls, suggesting that they may misinterpret ambiguous situations as more threatening, which could hinder their emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Generalization of Conscious Attentional Avoidance in Response to Threat Among Breast Cancer Women With Persistent Distress. Ng, DWL., Fielding, R., Lam, WWT.[2022]

Attention Bias Modification (ABM) significantly improved diagnostic remission in high-anxiety patients, with a 22.6% remission rate compared to 10.8% in control groups, based on a pooled analysis of data from 778 participants across 13 studies.

ABM effectively reduced attentional bias towards threats, indicating that it works through this mechanism to help reduce anxiety, particularly in younger patients and those trained in a lab setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled patient-level meta-analysis of children and adults completing a computer-based anxiety intervention targeting attentional bias. Price, RB., Wallace, M., Kuckertz, JM., et al.[2018]

In a study involving 59 clinically anxious children, those who underwent 12 sessions of attention bias modification training (ABMT) showed significant improvements in anxiety and depressive symptoms compared to a waitlist control group, with benefits lasting up to six months post-treatment.

The study found that children who effectively consolidated learning and memory strategies during ABMT experienced greater improvements in their overall functioning, suggesting that enhancing these cognitive processes can boost the efficacy of anxiety treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Look for good and never give up: A novel attention training treatment for childhood anxiety disorders. Waters, AM., Zimmer-Gembeck, MJ., Craske, MG., et al.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06682039

Attention Bias Modification for the Improvement of Anxiety ...

This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors.

2.

withpower.com

withpower.com/trial/phase-childhood-malignant-solid-neoplasm-10-2024-5f912

Attention Bias Modification for Anxiety in Childhood Cancer ...

Studies have found that children who underwent ABM experienced significant decreases in anxiety symptoms, and many no longer met the criteria for anxiety ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666915321000494

Efficacy of attention bias modification combined with ...

A study of people with anxiety disorders suggested that ABM improved the therapeutic efficacy rate of CBT, and a comparison of the Intervention group (ABM + CBT) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12050235/

Testing the effectiveness of combined attention modification ...

Findings suggested that cTBS combined with AMT treatment was not superior to sham cTBS and AMT on reducing self-reported anxiety symptoms.

5.

fredhutch.org

fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15153.attention-bias-modification-for-the-improvement-of-anxiety-in-adolescent-and-young-adult-cancer-survivors.html

Attention Bias Modification for the Improvement of Anxiety ...

This clinical trial studies how well attention bias modification (ABM) improves anxiety in adolescent and young adult (AYA) cancer survivors.

6.

journals.lww.com

journals.lww.com/10.1097/OR9.0000000000000153

Examining the feasibility of cognitive bias modification...

1. Active CBM training. Based on the evidence for attention but not interpretation bias in cancer survivors, 18 we trained attention bias only (in contrast to ...

7.

seattlechildrens.org

seattlechildrens.org/research/centers-programs/child-health-behavior-and-development/labs/pediatric-pain-and-sleep-innovations-lab/funded-research-projects/

Projects, Pediatric Pain and Sleep Innovations Lab

Aims: 1) Characterize attention bias in AYA cancer survivors and relationships to patient-reported mental health outcomes. 2) Evaluate the feasibility and ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3491316/

Attention Bias Modification Treatment for Pediatric Anxiety ...

The results suggest that ABM, but neither control condition, reduces pediatric anxiety symptoms and clinician severity ratings.