Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms

Browse trials for

• Hot Flashes 293

Keywords

• Menopause
• Menopausal Vasomotor Symptoms
• Cognitive Behavioural Therapy
• Internet-delivered Cognitive Behavioural Therapy
• Hot flashes
• Night sweats

Hot Flashes

293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 262 interventional studies indexed under Hot Flashes.

Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.

Study arms

• Experimental
  ICBT-Meno-VS

  Individual 4-week online CBT-based program

  Other: Internet-delivered Cognitive Behavioural Therapy

• Other
  Waitlist ICBT-Meno-VS

  Four-week waitlist, followed by the ICBT-Meno-VS program

  Other: Internet-delivered Cognitive Behavioural Therapy

Interventions

• OtherInternet-delivered Cognitive Behavioural Therapy

  This study is a randomized waitlist-controlled pilot study. The ICBT-Meno-VS program is based on CBT-Meno, a structured CBT protocol and accompanying workbook developed to help individuals manage menopause-related symptoms, including vasomotor symptoms, mood, sleep, and anxiety (Green et al., 2012; Green et al., 2019). The ICBT-Meno-VS program adapts these CBT-based strategies for delivery through an online, therapist-guided format and focuses on managing menopause-related vasomotor symptoms. Eligible participants will be randomly assigned to receive the 4-week ICBT-Meno-VS program immediately or to a 4-week waitlist. Participants assigned to the intervention group will complete the 4-week ICBT-Meno-VS program, followed by a post-treatment assessment, and a 3-month follow-up assessment. Participants assigned to the waitlist will complete a 4-week waitlist period and assessment, after which they will receive the 4-week ICBT-Meno-VS program, followed by a post-treatment assessment.

Primary outcomes

1. Feasibility: Recruitment Rate

   Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Recruitment rates, reflecting the portion of individuals that express interest and enroll in the study, will provide information about our recruitment process and whether this is sufficient for conducting the study. This will be calculated as a percentage of the proportion of individuals who express interest in the study and subsequently enroll.

   Time frame: Measured through the recruitment period (up to 12 months)

2. Feasibility: Eligibility Rate

   Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention, including the eligibility rate. Eligibility rate will be calculated as the proportion in percentage of screened individuals who meet inclusion and exclusion criteria.

   Time frame: Measured through the recruitment period (up to 12 months)

3. Feasibility: Homework Completion

   Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Homework completion will be used to assess engagement with treatment components. Homework completion will be assessed as the proportion of assigned homework tasks completed during the intervention period.

   Time frame: Measured during the treatment period, from the first to last session (up to 4 weeks)

4. Feasibility: Treatment Completion Rate

   Treatment completion rates will indicate whether the treatment is feasible for a menopausal population. Treatment completion will be defined as the proportion of participants who complete 4 out of 4 lessons.

   Time frame: Measured at the end of treatment (4 weeks)

5. Feasibility: Retention Rate

   Feasibility will be evaluated using descriptive statistics to determine the practicality of conducting the study and delivering the intervention. Retention rates (i.e., continued participation in study assessments - baseline, post-treatment, 3-month follow-up), will provide information about the feasibility of collecting outcome data over time.

   Time frame: Measured at baseline (at enrolment, 0 weeks), post-treatment (4 weeks), and 3-month follow-up (20 weeks)

6. Acceptability: Treatment Credibility/ Expectancy (TCQ)

   The Treatment Credibility instrument is a 4-item survey used to measure the participant's experience with the program and whether it helped them achieve their wellbeing goals. Items on the questionnaire are rated on a 10-point Likert scale, where 10 represents 'very confident', 'very logical', or 'very successful'.

   Time frame: Administered immediately at the end of the 4-week treatment

7. Acceptability: Internet-CBT Treatment Satisfaction Measure (ICBT-TS)

   The ICBT-TS is a post-treatment program satisfaction questionnaire used to assess participants' satisfaction with the internet-delivered CBT program and to evaluate treatment acceptability. The questionnaire will consist of forced-choice items related to course satisfaction (i.e., treatment platform, lessons, and overall program), rated on a 5-point Likert scale ranging from 1 (Very Dissatisfied) to 5 (Very Satisfied). Additional yes/no items will assess whether participants would recommend the course to a friend, whether they experienced any negative effects during the course, and whether the course was perceived as worth their time. Consistent with prior internet-delivered treatment studies, the ICBT-TS will include 19 items assessing overall program satisfaction and acceptability.

   Time frame: Administered immediately at the end of the 4-week treatment

8. Acceptability: measured using a Brief Qualitative Interview

   At one-week post-treatment, participants will attend a brief qualitative interview to review treatment progress and provide feedback on their care, including what aspects of the treatment were helpful and what could be improved, as well as feedback on the length of treatment and its delivery. This does not include a specific number or scale, rather, qualitative feedback on the treatment and their care will be reported on.

   Time frame: Administered one week after finishing the treatment

Secondary outcomes

1. Hot Flash Related Daily Interference Scale (HFRDIS)

   The HFRDIS is a validated scale which assesses the level of vasomotor interference in daily activities. Total scores range from 0-100, with scores of 30 or greater suggesting clinically significant interference related to vasomotor symptoms. Higher scores indicate greater symptom severity.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

2. Greene Climacteric Scale (GCS)

   The GCS is a validated 21-item self-report measure assessing menopausal symptom severity across psychological, somatic, vasomotor, and sexual domains. Items are rated on a 4-point scale from 0 ("not at all") to 3 ("extremely"), with higher scores indicating greater symptom severity. Vasomotor symptoms will be assessed using the vasomotor subscale (GCS-VM), which includes hot flashes and night sweats and yields total scores ranging from 0 to 6, with scores of 3 or greater indicating clinically significant vasomotor symptom severity. Sexual concerns will be assessed using the sex-specific item ("loss of interest in sex"), scored from 0 to 3.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

3. Hot Flush Behaviour Scale (HFBehS)

   The HFBehS is an 11-item self-report measure that assesses behaviors used to manage or respond to vasomotor symptoms during the menopausal transition. The scale comprises three subscales assessing behavioral avoidance, cooling behaviors, and positive coping behaviors. Items are rated based on the frequency of these responses, with higher scores indicating greater endorsement of each behavior type.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

4. Hot Flush Beliefs Scale (HFBS)

   The HFBS is a 27-item measure designed to assess beliefs and appraisals related to hot flashes and night sweats. The scale includes three domains: beliefs about the self in a social context (HFBSSelf; e.g., "When I have a hot flush, other people will think I am incompetent"), beliefs about coping with hot flashes (HFBS-HF; e.g., "When I have a hot flush, I think when will they ever end", and beliefs about coping with night sweats (HFBS-NS; e.g., "When I have night sweats, it is harder to cope the next day"). Items are rated on a Likert-type scale, with higher scores reflecting more negative or unhelpful beliefs about vasomotor symptoms.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

5. Patient Health Questionnaire-9 (PHQ-9)

   PHQ-9 contains 9 items that measure depression symptoms over the past 2 weeks based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PHQ, in the form of a self-report questionnaire (Kroenke et al., 2001) Total scores range from 0-27, where higher scores indicate greater severity of depression symptoms, and a total score of ≥ 10 is widely considered a standard for major depression, with scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

6. Generalized Anxiety Disorder 7-Item Scale (GAD-7)

   The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period (Spitzer et al., 2006). Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder (Spitzer et al., 2006).

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

7. Insomnia Severity Index (ISI)

   The ISI is a 7-item self-report questionnaire that assesses sleep quality via the nature, severity, and impact of insomnia (Morin, 1993; Bastien et al., 2001). Items are scored on a 5-point Likert scale ranging from 0 ('no problem') to 4 ('very severe problem') with higher scores reflecting greater insomnia severity. Total scores between 0-7 indicate an absence of insomnia; scores between 8-14 suggest sub-threshold insomnia; scores between 15-21 indicate moderate insomnia; and scores between 22-28 suggest severe insomnia.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

8. Menopause-Related Quality of Life (MENQOL)

   The MENQOL is a 29-item self-report measure assessing menopause-related quality of life across vasomotor, psychosocial, physical, and sexual domains. Items assess symptom-related bother over the past month on a 7-point Likert scale, with higher scores indicating poorer quality of life.

   Time frame: Administered at baseline (at enrolment), post-treatment (immediately after the 4-week intervention), and at the 3-month follow-up (3 months after intervention completion).

Individual participant data

Plan to share: No