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Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)

Primary Purpose

Hot Flashes, Menopause

Status

Terminated

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Applied relaxation

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Hot flashes, Menopause, HRQoL, Applied relaxation, Insomnia, Women's knowledge

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

A minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity)
Natural menopause (at least 12 months without any menstrual bleedings at all)
At least 45 years of age during present year
Access to computer with Internet
Ability to read and speak Swedish
Freely informed concent for participation

Exclusion Criteria:

Induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region)
Early or premature menopause (before 45 years of age)
Breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors
Ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes
Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or frequent use of benzodiazepines, drugs for insomnia(> 1 times/week)
Untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease)
Undiagnosed vaginal bleeding after menopause

Sites / Locations

County Council of Östergötland, Kvinnokliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Applied relaxation

Waiting-list/control

Arm Description

Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists

No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group

Outcomes

Primary Outcome Measures

Change in numbers of hot flashes per 24 h

Numbers of hot flashes per 24 h daily recorded in hot flash diary from baseline throughout 10 weeks of treatment. Comparison between treatment group and control group (waitlist)

Secondary Outcome Measures

Health related Quality of life (HRQoL)

HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)

Severity of insomnia

Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)

Women's knowledge about menopause and treatment of menopausal related symptoms

Knowledge measured with a questionnaire measuring women's knowledge about menopause and treatment of menopausal related symptoms at 10 baseline and after 10 weeks. Comparison between the treatment group and the control group (waitlist)

Change in numbers of hot flashes per 24 h, WHQ, ISI

Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group.

Adverse Event

Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)

Full Information

NCT ID

NCT01245907

First Posted

November 22, 2010

Last Updated

April 24, 2014

Sponsor

Mats Hammar

Collaborators

Linkoeping University

1. Study Identification

Unique Protocol Identification Number

NCT01245907

Brief Title

Climacteric Therapy With Applied Relaxation Using InterNet

Acronym

CARIN

Official Title

Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Unacceptable high drop-out rate.

Study Start Date

February 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mats Hammar

Collaborators

Linkoeping University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim is to evaluate effects of internet-based applied relaxation (a simplified version of cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is a non-treated waitlist group. At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as well as one about knowledge of the climacteric and hormone therapy). The waiting list group will be offered internet based AR after 10 weeks with the same follow-up as the treatment group.

Detailed Description

See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes, Menopause

Keywords

Hot flashes, Menopause, HRQoL, Applied relaxation, Insomnia, Women's knowledge

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Applied relaxation

Arm Type

Experimental

Arm Description

Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists

Arm Title

Waiting-list/control

Arm Type

No Intervention

Arm Description

No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group

Intervention Type

Behavioral

Intervention Name(s)

Applied relaxation

Intervention Description

Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists

Primary Outcome Measure Information:

Title

Change in numbers of hot flashes per 24 h

Description

Numbers of hot flashes per 24 h daily recorded in hot flash diary from baseline throughout 10 weeks of treatment. Comparison between treatment group and control group (waitlist)

Time Frame

Baseline to 10 weeks of treatment/control group

Secondary Outcome Measure Information:

Title

Health related Quality of life (HRQoL)

Description

HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)

Time Frame

Baseline to 10 weeks of treatment/control group

Title

Severity of insomnia

Description

Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)

Time Frame

Baseline to 10 weeks of tratment/control group

Title

Women's knowledge about menopause and treatment of menopausal related symptoms

Description

Time Frame

Baseline to 10 weeks of treatment/control group

Title

Change in numbers of hot flashes per 24 h, WHQ, ISI

Description

Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group.

Time Frame

Baseline to 6, 12 and 24 months after end treat treatment

Title

Adverse Event

Description

Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)

Time Frame

Baseline to 10 weeks of treatment/control group

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity) Natural menopause (at least 12 months without any menstrual bleedings at all) At least 45 years of age during present year Access to computer with Internet Ability to read and speak Swedish Freely informed concent for participation Exclusion Criteria: Induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region) Early or premature menopause (before 45 years of age) Breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors Ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or frequent use of benzodiazepines, drugs for insomnia(> 1 times/week) Untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease) Undiagnosed vaginal bleeding after menopause

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mats L Hammar, MD

Organizational Affiliation

Linkoeping University

Official's Role

Principal Investigator

Facility Information:

Facility Name

County Council of Östergötland, Kvinnokliniken

City

Linköping

ZIP/Postal Code

581 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

17225620

Citation

Nedstrand E, Wyon Y, Hammar M, Wijma K. Psychological well-being improves in women with breast cancer after treatment with applied relaxation or electro-acupuncture for vasomotor symptom. J Psychosom Obstet Gynaecol. 2006 Dec;27(4):193-9. doi: 10.1080/01674820600724797.

Results Reference

background

PubMed Identifier

15917156

Citation

Nedstrand E, Wijma K, Wyon Y, Hammar M. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Maturitas. 2005 Jun 16;51(2):154-62. doi: 10.1016/j.maturitas.2004.05.017.

Results Reference

background

PubMed Identifier

3318800

Citation

Ost LG. Applied relaxation: description of a coping technique and review of controlled studies. Behav Res Ther. 1987;25(5):397-409. doi: 10.1016/0005-7967(87)90017-9. No abstract available.

Results Reference

background

PubMed Identifier

12899896

Citation

Carlbring P, Ekselius L, Andersson G. Treatment of panic disorder via the Internet: a randomized trial of CBT vs. applied relaxation. J Behav Ther Exp Psychiatry. 2003 Jun;34(2):129-40. doi: 10.1016/s0005-7916(03)00026-0.

Results Reference

background

PubMed Identifier

19880935

Citation

Furmark T, Carlbring P, Hedman E, Sonnenstein A, Clevberger P, Bohman B, Eriksson A, Hallen A, Frykman M, Holmstrom A, Sparthan E, Tillfors M, Ihrfelt EN, Spak M, Eriksson A, Ekselius L, Andersson G. Guided and unguided self-help for social anxiety disorder: randomised controlled trial. Br J Psychiatry. 2009 Nov;195(5):440-7. doi: 10.1192/bjp.bp.108.060996.

Results Reference

background

PubMed Identifier

17519805

Citation

Lindh-Astrand L, Brynhildsen J, Hoffmann M, Kjellgren KI, Hammar M. Knowledge of reproductive physiology and hormone therapy in 53- to 54-year-old Swedish women: a population-based study. Menopause. 2007 Nov-Dec;14(6):1039-46. doi: 10.1097/gme.0b013e31803816ca.

Results Reference

background

PubMed Identifier

8259753

Citation

Wiklund I, Karlberg J, Lindgren R, Sandin K, Mattsson LA. A Swedish version of the Women's Health Questionnaire. A measure of postmenopausal complaints. Acta Obstet Gynecol Scand. 1993 Nov;72(8):648-55. doi: 10.3109/00016349309021159.

Results Reference

background

PubMed Identifier

9350957

Citation

Lisspers J, Nygren A, Soderman E. Hospital Anxiety and Depression Scale (HAD): some psychometric data for a Swedish sample. Acta Psychiatr Scand. 1997 Oct;96(4):281-6. doi: 10.1111/j.1600-0447.1997.tb10164.x.

Results Reference

background

PubMed Identifier

8072086

Citation

Karling P, Hammar M, Varenhorst E. Prevalence and duration of hot flushes after surgical or medical castration in men with prostatic carcinoma. J Urol. 1994 Oct;152(4):1170-3. doi: 10.1016/s0022-5347(17)32530-2.

Results Reference

background

PubMed Identifier

18364505

Citation

Holmberg L, Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpaa J; HABITS Study Group. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25. Erratum In: J Natl Cancer Inst. 2008 May 7;100(9):685. Maenpa, Johanna [corrected to Maenpaa, Johanna].

Results Reference

background

PubMed Identifier

3185293

Citation

Berg G, Gottwall T, Hammar M, Lindgren R. Climacteric symptoms among women aged 60-62 in Linkoping, Sweden, in 1986. Maturitas. 1988 Oct;10(3):193-9. doi: 10.1016/0378-5122(88)90022-9. Erratum In: Maturitas 1988 Dec;10(4):363. Gottgall T [corrected to Gottwall T].

Results Reference

background

PubMed Identifier

16023804

Citation

Hoffmann M, Hammar M, Kjellgren KI, Lindh-Astrand L, Brynhildsen J. Changes in women's attitudes towards and use of hormone therapy after HERS and WHI. Maturitas. 2005 Sep 16;52(1):11-7. doi: 10.1016/j.maturitas.2005.06.003.

Results Reference

background

PubMed Identifier

25700856

Citation

Lindh-Astrand L, Holm AC, Sydsjo G, Andersson G, Carlbring P, Nedstrand E. Internet-delivered applied relaxation for vasomotor symptoms in postmenopausal women: lessons from a failed trial. Maturitas. 2015 Apr;80(4):432-4. doi: 10.1016/j.maturitas.2015.01.010. Epub 2015 Feb 2.

Results Reference

derived

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Climacteric Therapy With Applied Relaxation Using InterNet

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