A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer

NCT03985267 | Completed DMC

• 1 other identifier: 2018/14-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. This intervention intended to support patients' management of their chronic illness (self-efficacy) by increasing their hope about their treatment and alleviate anxiety, as well as increase patient saturation level. Therefore, enabling patients to continue to their medical as well as psychological treatment will result improved anxiety, stress levels, hope and self-efficacy. It is known that mental health needs of cancer patients differ from people who do not suffer from a chronic illness.

Conditions

Anxiety; Stress; Self Efficacy; Depression; Breast Cancer Female; Hopefulness

Keywords

mindfulness; breast cancer; psycho-oncology; clinical health psychology; ontology; swinging effect intervention; breathing technique; guided imagery; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (8)

• Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety

  To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to reduce stress and anxiety for breast cancer patients. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

  20minutes

• Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy

  To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used right before and after the intervention. If two consecutive numbers are circled, the lower number will be coded (less self-efficacy). The score for the scale is the mean of the six items. If more than two items will be missing, scoring the scale will not happen. Higher number indicates higher self-efficacy.The higher values represent a better outcome for this scale.

  20 minutes

• Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness

  To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used right before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

  20 minutes

• Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy

  To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used before and after the intervention. Each of the 6 items are rated from 1 (not at all confident) to 10 (totally confident). The overall score is derived from the mean of the 6 items. The total minimum score will be 6 (very low self-efficacy), and maximum total score will be 60 (very high self-efficacy). Higher scores indicate a better self-efficacy.

  8 weeks

• Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness

  To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

  8 weeks

• Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the State Trait Anxiety Inventory.

  To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety State Trait Anxiety Inventory will be used before and after the intervention. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

  8 weeks

• Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using Emotion Thermometer.

  To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Emotion Thermometer will be used before and after the intervention. To calculate the Emotion Thermometer the fixed cut-offs will be used meaning that 0-3 (low) and 4-10 (high) on each component.

  8 weeks

• Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the Hospital Anxiety and Depression Scale.

  To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Hospital Anxiety and Depression Scale will be used before and after the intervention. To calculate Hospital Anxiety and Depression Scale the cut of scores are 0-7 considered in normal range, 8-10 considered in Borderline abnormal (borderline case) and 11-21 considered in Abnormal (case) respectively.

  8 weeks

Secondary Outcomes (5)

• Impact of education level on efficacy of the Mindfulness Based Swinging Technique (MBST)

  20 minutes to 8 weeks

• Impact of marital status on efficacy of the Mindfulness Based Swinging Technique (MBST)

  20 minutes to 8 weeks

• Impact of living arrangements on efficacy of the Mindfulness Based Swinging Technique (MBST)

  20 minutes to 8 weeks

• Impact of time for learning cancer diagnosis on efficacy of the Mindfulness Based Swinging Technique (MBST)

  20 minutes to 8 weeks

• Impact of having any metastasis on efficacy of the Mindfulness Based Swinging Technique (MBST)

  20 minutes to 8 weeks

Study Arms (2)

Mindfulness Based Swinging Technique (MBST)

EXPERIMENTAL

Standard guided imagery combined with Mindfulness and breathing technique will be applied. Additionally, the directives will be given to participants to imagine themselves swinging in a green peaceful environment where they will face no harm but healing and full of wellness. Every time they imagine their swing goes up, patient will be asked to physically take a deep breath (taking the breath will be physically (actually) done, not imagining), and when going down patient will be asked to physically release their breath (releasing breath will be physically (actually) done, not imagining).

Behavioral: Mindfulness based Swinging Effect Intervention

Standard Treatment

ACTIVE COMPARATOR

Participants will receive a session of standard psycho-social care for anxiety (50 minutes length). The standard psycho-social care interventions involve the most well-known talking therapy approach of Cognitive Behavioural Therapy (CBT).

Behavioral: Mindfulness based Swinging Effect Intervention

Interventions

Mindfulness based Swinging Effect Intervention BEHAVIORAL

Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.

Also known as: Breathing Technique, Guided Imagery Technique, Cognitive Behavioural Therapy (CBT), Mindfulness

Mindfulness Based Swinging Technique (MBST); Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only biological gender will be considered
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 and over who can consent
• Only women participants
• Diagnosed with breast cancer
• Native Turkish speaker
• Currently under cancer treatment (not in remission)
• Score at least 10 points for Hospital and Depression Scale (5 for anxiety, 5 for depression)
• Score at least 6 points for Self-Efficacy for Managing Chronic Disease (in overall)
• Score at least 2 points for the Beck's Hopelessness Scale (in overall)
• Score at least 20 points for State Trait Anxiety Inventory.

You may not qualify if:

• Being illiterate
• Having any type of psychiatric history
• Currently being on psychiatric/neurological medication
• Having mental retardation
• Having a fear of swings/swinging
• Having a severe respiratory illness/severe difficulty in breathing
• Suffering from any asthmatic or epileptic illnesses

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (2)

Ozel Oz Psikoloji Aile Danisma Merkezi (Oz Psychology Family Counselling Centre)

Izmir, Konak, Turkey (Türkiye)

Location

EgeMed Hospital

Aydin, Soke, Turkey (Türkiye)

Location

Related Publications (2)

• Bahcivan O, Estape T, Gutierrez-Maldonado J. The swinging effect intervention: CBT based guided imagery and breathing technique integrated with mindfulness therapy for cancer patients. Med Hypotheses. 2018 Dec;121:42-43. doi: 10.1016/j.mehy.2018.09.007. Epub 2018 Sep 6. No abstract available.

  PMID: 30396486 BACKGROUND

• Bahcivan O, Estape T, Gutierrez-Maldonado J. Efficacy of New Mindfulness-Based Swinging Technique Intervention: A Pilot Randomised Controlled Trial Among Women With Breast Cancer. Front Psychol. 2022 Jul 4;13:863857. doi: 10.3389/fpsyg.2022.863857. eCollection 2022.

  PMID: 35859820 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders; Depression; Breast Neoplasms

Interventions

Cognitive Behavioral Therapy; Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jose M Maldonado, PhD, MSc

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 13, 2019
• Study Start: November 29, 2018
• Primary Completion: August 1, 2021
• Study Completion: October 20, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: within 1 year of completion of the study.
• Access Criteria: it is available through international publication below. https://doi.org/10.3389/fpsyg.2022.1007065 https://doi.org/10.3389/fpsyg.2022.863857

Locations

TU (2)