Cognitive Behavioural Therapy for Menopausal Symptoms

NCT02480192 | Completed

• 1 other identifier: OMHF-SG1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Depression

Keywords

Vasomotor; Symptoms

Outcome Measures

Primary Outcomes (2)

• The Hot Flash Related Daily Interference Scale

  The Hot Flash Related Daily Interference Scale assesses the degree to which vasomotor functions interfere with daily life (Carpenter, 2001). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces vasomotor function daily interference, as captured by the Hot Flash Related Daily Interference Scale, compared to pre-treatment and wait-list controls.

  12 weeks

• The Beck Depression Inventory

  The Beck Depression Inventory is a multiple choice questionnaire which measures depressive symptoms (Beck, Steer \& Brown, 1996). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces subjective depressive symptoms, compared to pre-treatment and wait-list controls.

  12 weeks

Secondary Outcomes (20)

• The Greene Climacteric Scale - Vasomotor Subscale

  12 weeks

• The Montgomery-Asberg Depression Rating Scale

  12 weeks

• The Hamilton Anxiety Scale

  12 weeks

• The Pittsburgh Sleep Quality Inventory

  12 weeks

• Ambulatory Sternal Skin-Conductance Monitoring

  12 weeks

Study Arms (2)

Experimental Group (CBT-Meno)

EXPERIMENTAL

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.

Other: CBT for Menopausal Symptoms (CBT-Meno)

Waitlist

NO INTERVENTION

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.

Interventions

CBT for Menopausal Symptoms (CBT-Meno) 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.

Experimental Group (CBT-Meno)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
• A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
• 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).
• 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,
• Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

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

Hamilton, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 35881942 DERIVED

• 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.

  PMID: 32299247 DERIVED

Study Officials

• Sheryl Green, PhD, C.Psych

  St. Joseph's Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors evaluated symptoms at baseline, 12-weeks post-baseline, and 3-month follow-up. Assessors were unaware of participants' assigned condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Health Psychologist

Model Details: A single-blind, randomized controlled trial was conducted to assess the effectiveness of the CBT-Meno program compared to a waitlist comparison condition.

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

CA (1)