Mind-Body Interventions in Coronary Artery Disease
ConditionCoronary Artery Disease (CAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
Sponsorşeyda candeniz
About this trial
This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease.
A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only.
Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period.
The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with stable coronary artery disease
Aged between 18 and 65 years
Able to read and understand Turkish
Able to complete study questionnaires and assessments
Disqualifiers
History of acute coronary syndrome within the last 3 months
Presence of a diagnosed severe psychiatric disorder
Cognitive impairment or communication difficulties that may interfere with study participation
Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Muscle Relaxation and Guided Imagery
BehavioralA structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Perceived Stress Scale (PSS) Score
The primary outcome is the change in perceived stress levels measured by the Perceived Stress Scale (PSS) between baseline and the end of the 4-week intervention period.Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Time frame
Baseline and 4 weeksSecondary outcomes
1
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Change in anxiety measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Outcome will be assessed at baseline and 4 weeks.
Time frame
Baseline and 4 weeks2
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
Change in depression measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater depressive symptoms. Outcome will be assessed at baseline and 4 weeks.
Time frame
Baseline and 4 weeks3
Change in COPE Coping Strategies Scale Scores
Change in coping strategies measured by the COPE Inventory. The instrument contains 15 coping subscales, each scored from 4 to 16, with higher scores indicating greater use of the respective coping strategy. Outcomes will be assessed at baseline and 4 weeks.
Time frame
Baseline and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
şeyda candeniz
Lead sponsor
Ankara University
Sponsor institution
Source ClinicalTrials.gov