Impact of Cognitive Behavioural Therapy for Insomnia on Endocrine Therapy Adherence

NCT05887297 | Completed

• 1 other identifier: UEC23/09
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the impact of cognitive behavioural therapy for insomnia on adherence to endocrine therapy medication in breast cancer survivors.

Conditions

Insomnia; Breast Cancer; Adherence, Medication; Quality of Life; Survivorship

Outcome Measures

Primary Outcomes (1)

• Endocrine therapy adherence

  Primary outcome will be self-reported adherence to endocrine therapy medication, measured using the Medication Adherence Report Scale (MARS-5). Items are scored from 1-5. Responses are summed to create a total ranging from 1-20, with higher scores indicating better adherence.

  12 weeks

Secondary Outcomes (10)

• Insomnia symptoms

  12 weeks

• Depressive symptoms

  12 weeks

• Anxiety symptoms

  12 weeks

• Fatigue

  12 weeks

• Musculoskeletal pain

  12 weeks

Study Arms (2)

Cognitive behavioural therapy for insomnia

EXPERIMENTAL

Following randomisation, participants in the intervention group will receive the CBT-I intervention, delivered over 4 weeks.

Behavioral: Cognitive behavioural therapy for insomnia

Waitlist control

NO INTERVENTION

Participants in the waitlist condition will complete all measures at the same timepoints as the intervention group. They will receive the CBT-I intervention after completing the 12-week follow-up assessment. This will then be used as a baseline measure for these participants to compare to their post-intervention and follow-up after receiving the treatment.

Interventions

Cognitive behavioural therapy for insomnia BEHAVIORAL

CBT-I is a multi-component, evidence-based intervention which incorporates both cognitive and behavioural techniques to address symptoms of insomnia, aiming to improve satisfaction with the duration and quality of sleep by reducing trouble falling and/or staying asleep. CBT-I will be delivered over 4 weekly 1-hour sessions, via videoconferencing. Session 1 will include psychoeducation about sleep (the relationship between sleep and mental health, the '3P' model of insomnia), and begin to explain components of CBT-I (sleep restriction and relaxation). Session 2 will reinforce previous learning about these components and introduce stimulus control. Session 3 will introduce sleep hygiene and its importance in preventing poor sleep. Session will 4 discuss cognitive therapy techniques and relapse prevention.

Cognitive behavioural therapy for insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer
• Aged 18 or over
• Currently prescribed endocrine therapy medication
• Experience symptoms of insomnia
• Self-reported nonadherent to ET medication (e.g. forgetting to take, or deliberately taking a break from medication)
• Proficient in English language
• Access to videoconferencing

You may not qualify if:

• Undertaking shift work (i.e., irregular or night shifts)
• Pregnancy or breastfeeding
• Other unstable physical or mental health problem (including substance misuse)
• Received CBT-I within past 12 months
• Received chemotherapy or radiotherapy within past 4 weeks

Sponsors & Collaborators

• University of Strathclyde: lead

Study Sites (1)

University of Strathclyde

Glasgow, County (Optional), G1 1XQ, United Kingdom

Location

Related Publications (1)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Breast Neoplasms; Medication Adherence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly allocated to either intervention group or waitlist control. Intervention group will receive CBT-I intervention following randomisation. Waitlist control group will receive CBT-I after all measures have been completed.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 2, 2023
• Study Start: March 23, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)