Cognitive Behavioural Therapy for Menopausal Symptoms

NCT ID: NCT02480192

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2018-04-30

Brief Summary

This study examined the effectiveness of a new cognitive-behavioural therapy for menopausal symptoms (CBT-Meno). Half of participants were randomly assigned to the 12-week CBT-Meno program and half to a 12-week waitlist. Common menopause symptoms (i.e., hot flashes/night sweats, depression, anxiety, poor sleep, and sexual concerns) were assessed at baseline, 12-weeks post-baseline, and (for women in the CBT-Meno condition) at 3-month follow-up.

Detailed Description

Women going through the menopausal transition often experience adverse physical changes (e.g., hot flashes/night sweats, sleep difficulties, sexual concerns) in addition to emotional difficulties (e.g., depression, anxiety) that can significantly impact functioning and overall quality of life. To date, hormone therapy (HT) has been the most commonly used treatment to relieve symptoms of menopause. However, reports have questioned the safety of HT long-term (e.g., risk of heart attacks, strokes, cancer) for some women. Cognitive-behavioural therapy (CBT), has been proposed as a low-risk treatment for menopausal symptoms. The investigators developed a comprehensive non-pharmacological, CBT for menopausal symptoms (CBT-Meno), published the treatment manual (Green, McCabe, & Soares, 2012), and obtained initial evidence supporting the effectiveness of CBT-Meno in a single-sample pilot study (Green et al., 2013). The goal in the study reported here was to conduct a larger randomized controlled trial to evaluate the effectiveness of the CBT-Meno program compared to a waitlist condition. The investigators hypothesized that participants would experience less intense/disruptive hot flashes/night sweats, reduced depression and anxiety, improvement in sleep difficulties, and sexual concerns. The investigators also predicted that these benefits would be maintained at 3-month follow-up and that participants would report high treatment satisfaction.

Conditions

Menopausal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (CBT-Meno)

After an initial assessment, the experimental group received 12 weekly sessions (2 hours each) of group-based cognitive-behavioural therapy for menopausal symptoms (CBT-Meno) (up to n=8 per group). Symptoms that were targeted included vasomotor symptoms (hot flashes/night sweats), depressive symptoms, anxiety, poor sleep, and sexual concerns. Participants were re-assessed at 12-weeks post-baseline and at 3 months post-treatment.

Group Type: EXPERIMENTAL

CBT for Menopausal Symptoms (CBT-Meno)

Intervention Type: OTHER

This 12-week CBT-based group treatment program consists of a combination of components including: a) psychoeducation about the nature of menopause including examination about thoughts and beliefs, b) cognitive and behavioural modification related to vasomotor symptoms, c) cognitive-behavioural strategies for depression, e) cognitive-behavioural strategies for anxiety and panic, d) sleep hygiene and cognitive-behavioural strategies for sleep difficulties, f) psychoeducation and lifestyle and behavioural modifications for urogenital complaints, and g) psychoeducation and cognitive-behavioural strategies for sexual concerns.

Waitlist

After an initial assessment, the waitlist comparison group did not receive any treatment for 12 weeks. They were then re-assessed at 12-weeks post-baseline and this data was used to compare this group to the experimental group to determine the effectiveness of the CBT-Meno treatment. After this re-assessment participants in the waitlist condition were offered the same CBT-Meno treatment as the experimental group: 12 weekly sessions (2 hours long) of cognitive-behavioural therapy for menopausal symptoms.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBT for Menopausal Symptoms (CBT-Meno)

This 12-week CBT-based group treatment program consists of a combination of components including: a) psychoeducation about the nature of menopause including examination about thoughts and beliefs, b) cognitive and behavioural modification related to vasomotor symptoms, c) cognitive-behavioural strategies for depression, e) cognitive-behavioural strategies for anxiety and panic, d) sleep hygiene and cognitive-behavioural strategies for sleep difficulties, f) psychoeducation and lifestyle and behavioural modifications for urogenital complaints, and g) psychoeducation and cognitive-behavioural strategies for sexual concerns.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause

2. A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),

3. Significant vasomotor symptoms: i.e., vasomotor symptoms that are (a) frequent (≥ 4 hot flashes per day/night or 21 or more per week); (b) distressing (≥ 3 or more on the vasomotor subscale of the Greene Climacteric Scale); and (c) interfering (≥ 30 or greater on the Hot Flash Related Daily Interference Scale).

4. Not taking hormonal, anti-depressant, or any herbal therapies or if taking these medications they must be taking a stable dose for at least three months prior to the study and for the duration of the study,

5. Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.

Exclusion Criteria

1. Participants who are severely depressed/suicidal at the time of the screen or intake assessment that would warrant acute treatment and hence, render them unable to act as a wait list control participant if randomized to this condition,

2. Participants with Psychotic Disorders, or current Substance Dependence.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Sheryl Green

Clinical Health Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheryl Green, PhD, C.Psych

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care

Locations

Women's Health Concerns, St. Joseph's Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

Donegan E, Frey BN, McCabe RE, Streiner DL, Fedorkow DM, Furtado M, Green SM. Impact of the CBT-Meno protocol on menopause-specific beliefs, dysfunctional attitudes, and coping behaviors. Menopause. 2022 Aug 1;29(8):963-972. doi: 10.1097/GME.0000000000002003.

Reference Type: DERIVED

PMID: 35881942 (View on PubMed)

Green SM, Donegan E, McCabe RE, Fedorkow DM, Streiner DL, Frey BN. Objective and subjective vasomotor symptom outcomes in the CBT-Meno randomized controlled trial. Climacteric. 2020 Oct;23(5):482-488. doi: 10.1080/13697137.2020.1737929. Epub 2020 Apr 17.

Reference Type: DERIVED

PMID: 32299247 (View on PubMed)

Other Identifiers

OMHF-SG1

Identifier Type: -

Identifier Source: org_study_id