NCT06061029

Brief Summary

This study aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV). In a randomized controlled trial, 51 DV-victimized women were assigned to an intervention group (n = 27) or a waitlist control group (n = 24). The intervention was a five-week yoga- and mindfulness-based psychoeducation program. The researchers planned to provide support for the effectiveness of a brief yoga- and mindfulness-based psychoeducation program for improving the psychological health of DV-victimized women. Self-compassion and rumination were hypothesized as working mechanisms underlying the intervention's success.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 19, 2023

Last Update Submit

September 27, 2023

Conditions

Keywords

Brief yoga and mindfulnessonline psychoeducationself-compassionruminationdomestic violencepsychological health

Outcome Measures

Primary Outcomes (3)

  • Depression Anxiety Stress Scales-21

    To measure the occurrence of symptoms associated with depression, anxiety, and stress. In this scale, higher scores mean higher depression, anxiety, or stress.

    6 weeks

  • The Self-Compassion Scale-Short Form

    To measure self-compassion level. In this scale higher scores mean better/higher self-compassion.

    6 weeks

  • The Brief State Rumination Inventory

    To measure rumination level. In this scale higher scores mean higher rumination.

    6 weeks

Study Arms (2)

Yoga- and Mindfulness-Based Psychoeducation Program Group

EXPERIMENTAL
Behavioral: Brief Yoga- and Mindfulness-Based Psychoeducation Program

Waitlist Control Group

NO INTERVENTION

Interventions

A unique mindfulness psychoeducation program incorporating features of Hatha yoga and mindfulness-based cognitive therapy, plus the main concepts of self-compassion

Yoga- and Mindfulness-Based Psychoeducation Program Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navidreza Hosseinzadeh Asl

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rumination SyndromePsychological Well-Being

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 29, 2023

Study Start

March 10, 2023

Primary Completion

August 18, 2023

Study Completion

September 20, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations