Recruiting

CBT-I

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT04817163

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Professionally-administered booster face-to-face CBT-I sessions

Study Details

Brief summary:

Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics.

This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.

Conditions

Insomnia

Study ID

NCT04817163

Start date

Dec 13, 2019

Status verified date

Sep, 2024

Completion date

May 30, 2025

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • have received a diagnosis of non-metastatic cancer (any type)
  • to be aged 18 years and older
  • to be readily able to read and understand French or English
  • having the minimum cognitive abilities to read, understand and memorize information
  • having access to Internet

Exclusion Criteria:

  • having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
  • having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
  • having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stepped care CBT-I

Interventions

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Each week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.

Professionally-administered booster face-to-face CBT-I sessions

Patients who obtain an ISI score of 8 and more after completing the web-based CBT-I are "stepped up" and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment.

Primary outcome measure

  • Implementation (organizational) measures [ Time Frame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months ]
  • 1) Change in Insomnia Severity Index Scores [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 2) Change in sleep efficiency (SE) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 3) Change in sleep onset latency (SOL) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 4) Change in wake after sleep onset (WASO) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 5) Change in total wake time (TWT) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 6) Change in total sleep time (TST) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 7) Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 8) Fatigue Symptom Inventory (FSI) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 10) Satisfaction with Life Scale (SWLS) [ Time Frame: Pre-treatment and post-treatment (6-8 weeks later) ]
  • 1) Psychologists' adherence to the protocol [ Time Frame: Throughout the active phase, up to 20 months ]
  • 2) Psychologists' perceived self-efficiency [ Time Frame: Throughout the active phase, up to 20 months ]

Central Contacts and Locations

Central contacts

Josée Savard, Ph.D.

418-525-4444josee.savard@psy.ulaval.ca

Locations

Centre de recherche de L'Hôtel-Dieu de Québec

Recruiting

Québec, Canada, G1R 2J6

Contacts

Emilie Godin, B.A.

1-418-525-4444emilie.godin@crchudequebec.ulaval.ca

Principal Investigator:

Josée Savard, Ph.D.

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Insomnia
  • Cancer
  • Cognitive-behavioral therapy
  • Stepped care model
  • Self-administered treatment
  • Web-based intervention
  • Implementation
  • Cost-effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2024-09-19.