Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

Browse trials for

• Neoplasms 9,610
• Sleep Initiation and Maintenance Disorders 1,925

Keywords

• cancer survivorship
• insomnia
• stepped-care
• cognitive-behavioral therapy for insomnia

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 140 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Lead sponsor

Vrije Universiteit Brussel is the lead sponsor of 157 studies on the registry; 44 are open to participants now.

Study arms

• Active comparator
  eSTANDCBT-I

  An online standard Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention which spans over 10 weeks time. With online modules and two therapist (CBT-I certified psychologist) sessions.

  Behavioral: Standard web-based Cognitive Behavioral Therapy for Insomnia

• Experimental
  eSTEPCBT-I

  The eSTEPCBT-I intervention is a stepped-care CBT-I program delivered over 10 weeks. All participants begin with Step 1, a 4-week low-intensity sleep coaching intervention. After 4 weeks, insomnia severity is assessed using the Insomnia Severity Index (ISI). Participants who achieve remission (ISI \< 11) complete the intervention, whereas those with persistent insomnia symptoms (ISI ≥ 11) proceed to Step 2, the eSTANDCBT-I intervention delivered over the remaining 6 weeks.

  Behavioral: Stepped-care Cognitive Behavioral Therapy for Insomnia

• Other
  Care as Usual

  Care as usual with online sleep hygiene leaflet

  Other: Control arm - Care as usual with sleep hygiene leaflet

Interventions

• BehavioralStepped-care Cognitive Behavioral Therapy for Insomnia

  Step 1: Participants receive access to an online self-guided CBT-I module containing educational videos, psychoeducation, and behavioural exercises and 1 online face-to-face sleep coaching session delivered by a trained healthcare provider. The intervention includes sleep education and sleep hygiene, stimulus control, and individualized behavioural advice to improve sleep. Step 2: Participants who do not achieve remission after Step 1 proceed to Step 2, consisting of the eSTANDCBT-I intervention adapted to a 6-week treatment period. Participants receive six online CBT-I modules and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist. Step 2 incorporates the same evidence-based CBT-I techniques as the eSTANDCBT-I program. All participants receive Step 1. Only participants with persistent insomnia symptoms after the 4-week assessment proceed to Step 2. Participants also complete a daily sleep diary throughout the 10-week intervention.

  Also known as: eStepCBT-I

• BehavioralStandard web-based Cognitive Behavioral Therapy for Insomnia

  The eSTANDCBT-I intervention consists of a standard web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) program delivered over a 10-week period. The program includes six online self-guided sessions and two online face-to-face therapy sessions with a CBT-I-certified psychologist. Participants receive: access to an online CBT-I platform containing weekly modules with educational videos, interactive exercises, and supporting materials; and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist. The intervention incorporates evidence-based CBT-I components commonly used in face-to-face clinical practice, including: sleep education and sleep hygiene; sleep restriction therapy and stimulus control; cognitive restructuring of maladaptive sleep-related thoughts and beliefs; stress management; relaxation training; and daily-life integration and relapse prevention. Participants are asked to complete a daily sleep diary throughout the 10-week intervention.

  Also known as: eSTANDCBT-I

• OtherControl arm - Care as usual with sleep hygiene leaflet

  Participants will receive an online sleep hygiene brochure and may seek additional or new sleep support from their usual healthcare providers if needed during the study. No study-specific sleep intervention will be provided, and the care received will be monitored as usual care. Participants will also complete a logbook and sleep diary throughout the study to enable comparison with the experimental groups. After all data collection has been completed, all intervention materials, including the online eSTANDCBT-I program, will be made available to them.

  Also known as: Care as Usual with Sleep Hygiene Leaflet

Primary outcomes

1. Insomnia Severity as assessed by the Insomnia Severity Index (ISI)

   Insomnia severity is assessed using the Insomnia Severity Index (ISI), a validated 7-item questionnaire with a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity (worse outcome).

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

2. Insomnia Remission Rate assesed by use of the Insomnia Severity Index (ISI)

   Insomnia remission is defined as an ISI total score of 11 or lower (≤11). The remission rate is expressed as the percentage of participants achieving remission, with higher percentages indicating a better outcome.

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post-intervention, T2), and at 6 months (T3) and 12 months (T4) post-intervention.

Secondary outcomes

1. Use of additional (sleep-related) healthcare measured by the Medical Consumption Questionnaire (MCQ)

   Healthcare use is assessed using the Medical Consumption Questionnaire (MCQ), which records the frequency and type of healthcare services used by participants, including sleep-related healthcare consumption. Outcomes are expressed as the number of healthcare contacts or services used during the specified recall period. Higher values indicate greater healthcare use.

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

2. Productivity (loss) measured by use of the Productivity Cost Questionnaire (PCQ)

   Productivity loss is assessed using the Productivity Cost Questionnaire (PCQ), which measures productivity loss due to absenteeism and presenteeism. Outcomes are expressed as the number of hours of productivity loss, with higher values indicating greater productivity loss (worse outcome).

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

3. Sleep quality as assesed by the Pittsburgh Sleep Quality Index (PSQI)

   Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality and sleep disturbances over the past month. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome)

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

4. Health-Related Quality of Life (Utility) as assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

   Health-related quality of life is assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L), which evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The health utility score ranges from -0.532 to 1, with higher scores indicating better health-related quality of life. A score of 1 represents full health, while 0 represents death; negative values represent health states valued as worse than death, based on the Belgian EQ-5D-5L value set developed by Bouckaert et al.

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

5. Pain Intensity as Assessed by the Pain Visual Analogue Scale (VAS)

   Pain intensity is assessed using the Pain Visual Analogue Scale (VAS). Participants rate their pain over the past 2 weeks on a scale ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable. The minimum score is 0 and the maximum score is 10, with higher scores indicating greater pain intensity (worse outcome).y.

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

6. Symptoms of Central Sensitization as Assessed by the Central Sensitization Inventory (CSI)

   Symptoms of central sensitization are assessed using the Central Sensitization Inventory (CSI), a validated 25-item questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater severity of central sensitization-related symptoms (worse outcome).

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

7. Fatigue as assesed by the Brugmann Fatigue Scale (BFS)

   Fatigue is assessed using the Brugmann Fatigue Scale (BFS), an 8-item questionnaire assessing mental and physical fatigue. Each item is scored from 0 to 3. The Mental Fatigue subscale and Physical Fatigue subscale each range from 0 to 12, with higher scores indicating greater fatigue and greater propensity to rest (worse outcome).

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.

8. Daytime Sleepiness as Assessed by the Epworth Sleepiness Scale (ESS)

   Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome).

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.

9. Dysfunctional Beliefs and Attitudes About Sleep as Assessed by the Dysfunctional Beliefs and Attitudes About Sleep Scale - 16 Item (DBAS-16)

   Dysfunctional beliefs and attitudes about sleep are assessed using the 16-Item Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS-16). Each of the 16 items is rated from 0 to 10, with higher scores indicating stronger endorsement of dysfunctional beliefs and attitudes about sleep (worse outcome).

   Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.

10. Subjective Sleep Quality as Assessed by a Sleep Visual Analogue Scale (VAS)

    Subjective sleep quality is assessed using a Sleep Visual Analogue Scale (VAS). Participants rate their sleep quality over the past 2 weeks on a scale ranging from 0 to 10, with 0 indicating very poor sleep quality and 10 indicating excellent sleep quality. Higher scores indicate better subjective sleep quality.

    Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.

11. Sleep Chronotype as Assessed by the Munich Chronotype Questionnaire (MCTQ)

    Sleep chronotype is assessed using the Munich Chronotype Questionnaire (MCTQ). Chronotype is estimated using the sleep-corrected midpoint of sleep on free days (MSFsc), expressed as clock time. MSFsc represents the midpoint of sleep on free days corrected for sleep debt accumulated during workdays. Earlier clock times indicate an earlier chronotype, while later clock times indicate a later chronotype.

    Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.

12. Pain Severity as Assessed by the Brief Pain Inventory (BPI)

    Pain severity is assessed using the Brief Pain Inventory (BPI) through four items assessing worst pain, least pain, average pain, and pain right now. Each item is scored from 0 (no pain) to 10 (pain as bad as you can imagine). The mean pain severity score ranges from 0 to 10, with higher scores indicating greater pain severity (worse outcome).

    Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

13. Health-Related Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Health-related quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status/quality of life scale is scored from 0 to 100, with higher scores indicating better health-related quality of life.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

14. Depressive Symptoms as Assessed by the Depression Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)

    Depressive symptoms are assessed using the Depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe depressive symptoms (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

15. Anxiety Symptoms as Assessed by the Anxiety Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)

    Anxiety symptoms are assessed using the Anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe anxiety symptoms (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

16. Stress Symptoms as Assessed by the Stress Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)

    Stress symptoms are assessed using the Stress subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe stress symptoms (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

17. Bodily Threat Monitoring as Assessed by the Bodily Threat Monitoring Scale (BTMS)

    Bodily threat monitoring is assessed using the validated Bodily Threat Monitoring Scale (BTMS). The scale assesses the tendency to monitor bodily sensations and concerns about bodily sensations. The total score ranges from 0 to 24, with higher scores indicating a greater tendency to monitor bodily sensations.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

18. Fear of cancer recurrence as assesed using the Fear of Cancer Recurrence Inventory (FCRI).

    Fear of cancer recurrence is assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI consists of 42 items rated on a 5-point scale from 0 to 4. The total score ranges from 0 to 168, with higher scores indicating greater fear of cancer recurrence (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

19. Perceptions of Insomnia as Assessed by self-designed study-specific questions

    Perceptions of insomnia are assesed using three self-designed study-specific questions which are based on the Ilness Cognition Questionnaire (ICQ). Self-designed study specific questions were used to reduce patient burden. Participants rate their response on a scale from 0 to 100, with 0 indicating that insomnia perceptions are not negatively impacting their life and 100 indicating that insomnia has a significant impact on their lives. Higher scores indicate greater perceived negative outcomes related to insomnia.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

20. Perceptions about cancer as assesed by self-designed study-specific questions

    Perceptions of cancer are assesed using three self-designed study-specific questions which are based on the Ilness Cognition Questionnaire (ICQ). Self-designed study specific questions were used to reduce patient burden. Participants rate their response on a scale from 0 to 100, with 0 indicating that cancer perceptions are not negatively impacting their life and 100 indicating that cancer has a significant impact on their lives. Higher scores indicate greater perceived negative outcomes related to cancer.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

21. Physical Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

    Physical fatigue is assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater physical fatigue (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

22. Mental Fatigue as assessed by the Multidimensional Fatigue Inventory

    Mental fatigue is assessed using the Mental Fatigue subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater mental fatigue (worse outcome).

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

23. Reduced Motivation as assessed by the Multidimensional Fatigue Inventory

    Reduced motivation is assessed using the Reduced Motivation subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater reduction in motivation.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

24. Reduced Activity as assessed by the Multidimensional Fatigue Inventory

    Reduced activity is assessed using the Reduced Activity subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater reduction in activity.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

25. Pain Interference as Assessed by the Brief Pain Inventory (BPI)

    Pain interference is assessed using the Brief Pain Inventory (BPI) through seven items assessing interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (does not interfere) to 10 (completely interferes). The mean pain interference score ranges from 0 to 10, with higher scores indicating greater pain interference (worse outcome).

    Time frame: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

26. Perceived injustve as assesed by use of the injustice Experience Questionnaire (IEQ)

    Perceived Injustice is assed by use of the Injustice Experience Questionnaire (IEQ). The Injustice experience Questionnaire has 12 items (ranging 0-4) with a total score ranging from 0-48. A total score on of 17 or more indicates the presence of cliniclly relevant perceived injustice by the participant.

    Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

Other outcomes

1. Healthcare Utilization as Assessed by the Medical Consumption Questionnaire (MCQ)

   Healthcare utilization is assessed using the Medical Consumption Questionnaire (MCQ). The questionnaire records participants' use of healthcare services, including contacts with different healthcare providers. Healthcare utilization is reported as the frequency and type of healthcare contacts and services used during the specified recall period. Higher numbers indicate greater healthcare utilization.

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

2. Sleep onset latency as assesed by use of a daily sleep diary

   Participant-reported sleep onset latency is assessed using a daily sleep diary. Sleep onset latency is defined as the time in minutes between attempting to fall asleep and sleep onset. Higher values indicate longer sleep onset latency.

   Time frame: Two weeks before baseline and daily during the intervention period of 10 weeks (T0-2weeks to T2).

3. Physical activity as assesed by the Trial Specific Questionnaire

   Physical activity is assessed using study-specific questions included in the Trial Specific Questionnaire (TSQ). Participants report their physical activity during the specified recall period. Physical activity is reported according to the frequency and duration of physical activity.

   Time frame: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).

4. Wake after sleep onset (WASO) as assesed by a daily sleep diary

   Participant-reported wake after sleep onset (WASO) is assessed using a daily sleep diary. WASO is defined as the total time in minutes spent awake after initially falling asleep and before final awakening. Higher values indicate more wakefulness during the sleep period.

   Time frame: Two weeks before baseline and daily during the 10-week intervention period (T0-2 weeks to T2).

5. Total sleep time (TST) as assesed by use of a daily sleep diary

   Participant-reported total sleep time (TST) is assesed using a daily sleep diary. Total Sleep Time (TST) is the total amount of time spent asleep per night, reported in hours. Higher values indicate a greater amount of sleep.

   Time frame: Two weeks before baseline and daily during the 10-week intervention period (T0-2 weeks to T2).

6. Time in bed (TIB) as assesed using a daily sleep diary

   Participant-reported time in bed (TIB), assesed using a daily sleep diary. Time in Bed (TIB) is the total duration between bedtime and risetime, reported in hours. Higher values indicate a longer time spent in bed.

   Time frame: Two weeks before baseline and daily during the 10-week intervention period (T0-2 weeks to T2).

7. Sleep efficiency (SE) is assesed using a daily sleep diary

   Participant-reported sleep efficiency (SE) is assesed using a daily sleep diary. Sleep efficiency is the percentage of time in bed spent asleep, calculated as total sleep time divided by time in bed x 100. Scores range from 0% to 100%, with higher values indicating a greater proportion of time in bed spent asleep.

   Time frame: Two weeks before baseline and daily during the 10-week intervention period (T0-2 weeks to T2).

8. Variability in bed and risetime assesed using a daily sleep diary

   Participant-reported variability in bedtime and risetime, assessed using a daily sleep diary. Variability in bedtime and risetime is calculated as the standard deviation of the reported bedtimes and risetimes, respectively, across the assessment period, expressed in hours. Lower values indicate less variability (i.e., greater regularity), while higher values indicate greater variability.

   Time frame: Two weeks before baseline and daily during the 10-week intervention period (T0-2 weeks to T2).

9. Participants' personal history of cancer as assesed using the Trial Specific Questionnaire (TSQ)

   Participants' personal history of cancer will be assessed using the Trial Specific Questionnaire (TSQ). The assessment will include information on previous cancer diagnoses, cancer stage, and treatment history.

   Time frame: At baseline (T0).

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan