Anxiety DisordersNCT05981417
Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.
A study testing Therapeutic exercise in people with Anxiety Disorders and Depressive Symptoms, run by University of Vigo at 2 sites in Spain.
Trial summary
The scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). In particular, a recent study carried out in Galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorders, Depressive Symptoms, Gender-based Violence
- What is being tested?
- Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Oct 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of legal age with a history of gender-based violence who come to the women's center or are included in the women's center's programs.
Who cannot join
- Consumption of alcohol or other drugs.
- Musculoskeletal disorders, recent surgery, as well as any physical problem that prevents exercise.
- Any medical contraindication to exercise.
- Pregnancy.
- Having any affirmative answer in the PARQ questionnaire (Physical Activity Readiness Questionnaire).
- Participants who do not have the capacity to consent to participate will be excluded.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Vigo
Pontevedra, 36005
Lorenzo Justo Cousiño
Pontevedra
About this study
Official title: Effect of a Physiotherapy Intervention Based on Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.
The scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). In particular, a recent study carried out in Galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence.
The efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated, as has the link between gender violence and deterioration of mental health, with a high incidence of post-traumatic stress. However, research on the effect of therapeutic exercise in battered women is very limited.
For this reason, the aim of the present project is to evaluate the effect of a therapeutic exercise program on mental health in women who have suffered gender violence.
- Being tested
- Therapeutic exercise
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
Therapeutic exercise sessions will be guided by a physiotherapist.
Therapeutic exerciseOther
Therapeutic exercise sessions will be performed at home.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise | Experimental | Exercise sessions will beguided by a physiotherapist. Receives: Other: Therapeutic exercise |
| Home exercise | Active comparator | Exercise sessions will be perfomed at home. Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being assessed by Ryff psychological well-being scale.
This self-report instrument consist of a series of statements reflecting the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start16 Oct 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Información Municipal á Muller de Poio, Centro de Información Municipal á Muller de Pontevedra
- Responsible party
- Principal investigator, Lorenzo Antonio Justo Cousino, PhD, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981417
- Sponsor's protocol ID
- UVigo
- Status last verified
- May 2024
- First submitted
- 31 Jul 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dragesund T, Raheim M. Norwegian psychomotor physiotherapy and patients with chronic pain: patients' perspective on body awareness. Physiother Theory Pract. 2008 Jul-Aug;24(4):243-54. doi: 10.1080/09593980701738400.
PubMed 18574750Friis S, Skatteboe UB, Hope MK, Vaglum P. Body awareness group therapy for patients with personality disorders. 2. Evaluation of the Body Awareness Rating Scale. Psychother Psychosom. 1989;51(1):18-24. doi: 10.1159/000288129.
PubMed 2602528Strohle A. Sports psychiatry: mental health and mental disorders in athletes and exercise treatment of mental disorders. Eur Arch Psychiatry Clin Neurosci. 2019 Aug;269(5):485-498. doi: 10.1007/s00406-018-0891-5. Epub 2018 Mar 21.
PubMed 29564546Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30.
PubMed 33256493Carek PJ, Laibstain SE, Carek SM. Exercise for the treatment of depression and anxiety. Int J Psychiatry Med. 2011;41(1):15-28. doi: 10.2190/PM.41.1.c.
PubMed 21495519Ross RE, VanDerwerker CJ, Saladin ME, Gregory CM. The role of exercise in the treatment of depression: biological underpinnings and clinical outcomes. Mol Psychiatry. 2023 Jan;28(1):298-328. doi: 10.1038/s41380-022-01819-w. Epub 2022 Oct 17.
PubMed 36253441Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21.
PubMed 33890431Herring MP, Jacob ML, Suveg C, Dishman RK, O'Connor PJ. Feasibility of exercise training for the short-term treatment of generalized anxiety disorder: a randomized controlled trial. Psychother Psychosom. 2012;81(1):21-8. doi: 10.1159/000327898. Epub 2011 Nov 22.
PubMed 22116310Jonker IE, Lako DAM, Beijersbergen MD, Sijbrandij M, van Hemert AM, Wolf JRLM. Factors Related To Depression and Post-Traumatic Stress Disorder in Shelter-Based Abused Women. Violence Against Women. 2019 Mar;25(4):401-420. doi: 10.1177/1077801218790700. Epub 2018 Aug 20.
PubMed 30124130Mondolfi Miguel ML, Rosa Pino-Juste M. Psycho-social profile of battered women in Galicia, Spain: Distress as a result of intimate partner violence and child abuse. Health Care Women Int. 2019 Nov;40(11):1229-1248. doi: 10.1080/07399332.2019.1571061. Epub 2019 Feb 12.
PubMed 30753120Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8. doi: 10.1016/j.amepre.2004.09.003.
PubMed 15626549Gordon BR, McDowell CP, Lyons M, Herring MP. Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Sci Rep. 2020 Oct 16;10(1):17548. doi: 10.1038/s41598-020-74608-6.
PubMed 33067493
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physiotherapy Intervention Based on Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.
- ClinicalTrials.gov ID
- NCT05981417
- Acronym / sponsor ID
- UVigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Centro de Información Municipal á Muller de Poio, Centro de Información Municipal á Muller de Pontevedra
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). In particular, a recent study carried out in Galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence.
The efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated, as has the link between gender violence and deterioration of mental health, with a high incidence of post-traumatic stress. However, research on the effect of therapeutic exercise in battered women is very limited.
For this reason, the aim of the present project is to evaluate the effect of a therapeutic exercise program on mental health in women who have suffered gender violence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise | Experimental | Other: Therapeutic exerciseExercise sessions will beguided by a physiotherapist. |
| Home exercise | Active comparator | Other: Therapeutic exerciseExercise sessions will be perfomed at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women of legal age with a history of gender-based violence who come to the women's center or are included in the women's center's programs.
Key exclusion criteria (6 listed)
- Consumption of alcohol or other drugs.
- Musculoskeletal disorders, recent surgery, as well as any physical problem that prevents exercise.
- Any medical contraindication to exercise.
- Pregnancy.
- Having any affirmative answer in the PARQ questionnaire (Physical Activity Readiness Questionnaire).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exerciseTherapeutic exercise sessions will be guided by a physiotherapist. | Other | Supervised exercise |
| Therapeutic exerciseTherapeutic exercise sessions will be performed at home. | Other | Home exercise |
Primary outcome
Psychological well-being assessed by Ryff psychological well-being scale.
Time frame: 8 weeks
This self-report instrument consist of a series of statements reflecting the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 18574750Dragesund T, Raheim M. Norwegian psychomotor physiotherapy and patients with chronic pain: patients' perspective on body awareness. Physiother Theory Pract. 2008 Jul-Aug;24(4):243-54. doi: 10.1080/09593980701738400.
- Background: PubMed 2602528Friis S, Skatteboe UB, Hope MK, Vaglum P. Body awareness group therapy for patients with personality disorders. 2. Evaluation of the Body Awareness Rating Scale. Psychother Psychosom. 1989;51(1):18-24. doi: 10.1159/000288129.
- Background: PubMed 29564546Strohle A. Sports psychiatry: mental health and mental disorders in athletes and exercise treatment of mental disorders. Eur Arch Psychiatry Clin Neurosci. 2019 Aug;269(5):485-498. doi: 10.1007/s00406-018-0891-5. Epub 2018 Mar 21.
- Background: PubMed 33256493Smith PJ, Merwin RM. The Role of Exercise in Management of Mental Health Disorders: An Integrative Review. Annu Rev Med. 2021 Jan 27;72:45-62. doi: 10.1146/annurev-med-060619-022943. Epub 2020 Nov 30.
- Background: PubMed 21495519Carek PJ, Laibstain SE, Carek SM. Exercise for the treatment of depression and anxiety. Int J Psychiatry Med. 2011;41(1):15-28. doi: 10.2190/PM.41.1.c.
- Background: PubMed 36253441Ross RE, VanDerwerker CJ, Saladin ME, Gregory CM. The role of exercise in the treatment of depression: biological underpinnings and clinical outcomes. Mol Psychiatry. 2023 Jan;28(1):298-328. doi: 10.1038/s41380-022-01819-w. Epub 2022 Oct 17.
- Background: PubMed 33890431Schuch FB, Vancampfort D. Physical activity, exercise, and mental disorders: it is time to move on. Trends Psychiatry Psychother. 2021 Jul-Sep;43(3):177-184. doi: 10.47626/2237-6089-2021-0237. Epub 2021 Apr 21.
- Background: PubMed 22116310Herring MP, Jacob ML, Suveg C, Dishman RK, O'Connor PJ. Feasibility of exercise training for the short-term treatment of generalized anxiety disorder: a randomized controlled trial. Psychother Psychosom. 2012;81(1):21-8. doi: 10.1159/000327898. Epub 2011 Nov 22.
- Background: PubMed 30124130Jonker IE, Lako DAM, Beijersbergen MD, Sijbrandij M, van Hemert AM, Wolf JRLM. Factors Related To Depression and Post-Traumatic Stress Disorder in Shelter-Based Abused Women. Violence Against Women. 2019 Mar;25(4):401-420. doi: 10.1177/1077801218790700. Epub 2018 Aug 20.
- Background: PubMed 30753120Mondolfi Miguel ML, Rosa Pino-Juste M. Psycho-social profile of battered women in Galicia, Spain: Distress as a result of intimate partner violence and child abuse. Health Care Women Int. 2019 Nov;40(11):1229-1248. doi: 10.1080/07399332.2019.1571061. Epub 2019 Feb 12.
- Background: PubMed 15626549Dunn AL, Trivedi MH, Kampert JB, Clark CG, Chambliss HO. Exercise treatment for depression: efficacy and dose response. Am J Prev Med. 2005 Jan;28(1):1-8. doi: 10.1016/j.amepre.2004.09.003.
- Background: PubMed 33067493Gordon BR, McDowell CP, Lyons M, Herring MP. Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Sci Rep. 2020 Oct 16;10(1):17548. doi: 10.1038/s41598-020-74608-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise in people with Anxiety Disorders and Depressive Symptoms, run by University of Vigo at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological well-being assessed by Ryff psychological well-being scale. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981417, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.