Online programs for sleep problems and low mood in breast cancer survivors

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women who had breast cancer and now have both trouble sleeping (insomnia) and depression. It tests digital programs for these problems.

Age

18 years and older

Sex

Women only

Disease stage

Stage 0-3 breast cancer. Insomnia score (ISI) of 10 or more and depression score (PHQ-8) of 10 or more. Must meet DSM 5 criteria for insomnia and depression.

Earlier treatment

Main cancer treatment (chemotherapy, immunotherapy, radiation, surgery) finished between 3 months and 5 years before joining. Ongoing adjuvant hormonal, endocrine and immunotherapy are allowed.

Main reasons for not taking part

• Current behavioral or psychological treatment for insomnia or depression, or a change in medicine for them in the past 4 weeks
• Irregular sleep times or shift work (bedtime outside 8:00 p.m.-2:00 a.m. or waking outside 4:00 a.m.-10:00 a.m.)
• History of psychosis or bipolar disorder, or active suicidal thoughts needing more intense care
• Other untreated sleep disorders, such as obstructive sleep apnea or restless legs syndrome
• No reliable smartphone internet access, cannot read and speak English, or not living in the US

The registry criteria, word for word

What the trial wants to find out

Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available. Digital health interventions are scalable and accessible. Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia/depression has not been tested. The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.

The 3 groups in the trial

• Digital Insomnia Program FirstTreatment being tested

  Participants assigned to receive the digital insomnia program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.

  Treatment: Digital Insomnia Program and Digital Mental Health Program

• Digital Mental Health Program FirstTreatment being tested

  Participants assigned to receive the digital mental health program first will use it for 9 weeks. Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.

  Treatment: Digital Insomnia Program and Digital Mental Health Program

• Psychoeducation OnlyExisting treatment, for comparison

  Participants assigned to this arm will only receive the psychoeducation program for 9 weeks. They will not be eligible to be re-randomized to receive additional program.

  Treatment: Psychoeducation