Contemplative Practice for Well-being and Self-Deconstruction in Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorHospital Miguel Servet

About this trial

This randomized controlled trial aims to evaluate the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women. Participants will be randomly assigned to either FYD or an active control group practicing mindfulness meditation. Psychological variables will be assessed before and after the intervention, and at a six-month follow-up. Additionally, a qualitative exploration will be conducted through interviews with a subgroup of participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sex assigned female at birth and self-identifies as a woman

Aged between 30 and 60 years

Spanish nationality, or residency in Spain for more than 5 years

Fluent in Spanish

Disqualifiers

Indicators of eating disorders (ED) or mental health deterioration, determined by the following cut-off points: SCOFF ≥ 2 and PHQ-9 ≥ 10

Formal diagnosis of an eating disorder or any psychiatric condition

Substance use disorder

History of neurological disease diagnosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Feeding your demons practice

    Behavioral

    The Feeding Your Demons (FYD) is a contemplative practice based on the Tibetan Buddhist tradition, adapted in a secular form. The intervention is online and lasts a total of 8 weeks. During this period, participants will engage in weekly home practice of the FYD method using guided audio. The intervention includes 3 expert-facilitated sessions: an initial individual session, a group session at week 4, and a final group session at week 8.

  • Mindfulness practice

    Behavioral

    The control group will undergo an online mindfulness meditation intervention, lasting a total of 8 weeks. It includes 3 expert-facilitated sessions: an initial individual session, a group session at week 4, and a final group session at week 8. Participants will engage in weekly home practice of mindfulness meditation using guided audio.

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Feeding Your Demons practiceExperimental treatment 1 intervention
Group B: Mindfulness Meditation conditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Delusion of Me Index (DoM)

The primary outcome will be the change in self-related perception from baseline to 6-month follow-up after randomisation. This includes changes in acceptance, decentering, and non-attachment. Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.

Time frame
From baseline to 6-month follow-up
2

Nondual Awareness Dimensional Assessment (NADA)

The primary outcome will be the change in self-related perception from baseline to 6-month follow-up after randomisation. This outcome includes changes in nondual awareness. Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.

Time frame
From baseline to 6-month follow-up
3

Body Appreciation Scale-2 (BAS-2)

The second primary outcome will be the change in body image from baseline to 6-month follow-up after randomisation. This includes improvements in positive body image, specifically body appreciation. Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.

Time frame
From baseline to 6-month follow-up
4

Body Shape Questionnaire-10 (BSQ-10)

The second primary outcome will be the change in body image from baseline to 6-month follow-up after randomisation. This includes reductions in negative body image, specifically body dissatisfaction. Participants will complete this measure at three time points: baseline (week 0), post-intervention (week 8), and 6-month follow-up.

Time frame
From baseline to 6-month follow-up

Secondary outcomes

1

Pemberton Happiness Index (PHI)

Change in Psychological Well- Being

Time frame
From baseline to 6-month follow-up
2

SOCS-S Sussex-Oxford Self- Compassion Scale

Change in Self - Compassion

Time frame
From baseline to 6-month follow-up
3

Five Facet Mindfulness Questionnaire (FFMQ).

Change in Mindfulness

Time frame
From baseline to 6-month follow-up
4

Body Image Acceptance and Action Questionnaire (BI-AAQ-5).

Change in Body Acceptance

Time frame
From baseline to 6-month follow-up

Other outcomes

1

Participant Age

Age of participants, measured in years.

Time frame
At baseline
2

Place of Residence

The place of residence (e.g., community or city) of participants will be recorded at baseline.

Time frame
At baseline
3

Education Level

Participants will report their highest completed education level at baseline.

Time frame
At baseline
4

Employment Status

Employment status (e.g., employed, unemployed, student) will be collected at baseline.

Time frame
At baseline

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