Effect of Mindfulness-based Psychoeducation in Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Gaziantep

About this trial

Major depression is a mental illness that seriously threatens public health, leading to disability, reduced quality of life, economic burden, and premature death. It is estimated that 18.4% of the world's population lived with depression between 2005 and 2015, and it is projected to be a leading cause of global disease burden by 2030. Major depressive disorder manifests with symptoms such as decreased interest and desire, a depressed mood, increased or decreased sleep and appetite, feelings of worthlessness and guilt, decreased energy, suicidal thoughts and attempts, leading to significant impairment in functioning. Choosing the appropriate treatment for depression and taking measures to improve the individual's functionality quickly, shorten hospital stays, and reduce the number of hospitalizations are crucial. In addition to pharmacological treatment, clinical guidelines recommend the combined use of pharmacological and psychosocial interventions in the treatment of depression. The mindfulness-based cognitive therapy, which forms the basis of the psychoeducation planned for this study, was developed as an 8-week group approach. Theoretical studies examining emotion regulation mechanisms have indicated that mindful awareness is a fundamental mechanism for emotion regulation. The literature suggests a negative correlation between mindful awareness and the severity of depressive symptoms and difficulty in emotion regulation. Furthermore, despite numerous descriptive, correlational, and experimental studies on major depression, no studies have been found demonstrating the effect of mindful awareness-based psychoeducation on emotion regulation difficulties, distress tolerance, and symptom severity in patients diagnosed with major depression. This study, therefore, differs from existing research and will make a significant contribution to the literature.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Volunteering to participate in the study

Residing in Gaziantep city center

Not having any communication impediments

Being between 18 and 65 years of age

Disqualifiers

Those diagnosed with another comorbid mental illness

Patients with mental conditions that make cooperation impossible, such as intellectual disability or dementia

Those who are illiterate

Patients who do not consent to the interview

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-based psychoeducation

    Other intervention

    The experimental group will receive an 8-session mindfulness-based psychoeducation program, administered twice a week for four weeks. Each session of the eight-week program will be 45-60 minutes long. Sessions will be conducted in groups. Following an initial face-to-face meeting to inform the experimental group about the program and schedule meetings, the sessions will continue in person. Each group will consist of 7 people, with a total of 5 groups. Patients will be contacted by phone before each session to remind them of the program time. Immediately after the program sessions are completed, the experimental group will take a post-test. Additionally, follow-up tests will be administered two months after the program is completed. The control group will receive a pre-test followed by no intervention; a post-test will be administered two months later, and follow-up tests two months after the post-test.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: experimental groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Beck Depression Inventory (BDI)

Beck Depression Inventory (BDI): Developed by Beck in 1961, the Beck Depression Inventory is designed to measure the risk of depression, the level of depressive symptoms, and variations in severity in adults. Consisting of 21 items, each item in the BDI has four options. Each item is scored between 0 and 3. The sum of these scores yields a depression score. The highest possible score is 63, and a higher total score indicates a higher severity of depression. In the Turkish adaptation of the BDI by Hisli (1988, 1989), the Cronbach α reliability coefficient was determined as α=0.80 in the validity and reliability study.

Time frame
1.5 years

Secondary outcomes

1

Distress Tolerance Scale (DTS):

Distress Tolerance Scale (DTS): The Distress Tolerance Scale (DTS) is a self-report scale developed by Gather and Simons in 2005 to measure individuals' capacity to tolerate distress. It consists of 15 questions providing a five-point Likert-type measurement. Higher scores indicate a high capacity for tolerating distress. The scale has three sub-dimensions: tolerance, regulation, and self-efficacy. The Turkish adaptation of the scale was carried out by Sargın et al. in 2012. The Cronbach's alpha reliability coefficient of the scale was found to be 0.89, and between 0.64-0.90 for the sub-dimensions.

Time frame
1.5 years
2

Personal Information Form

Prepared by the researcher, this personal information form consists of 12 questions aimed at determining gender, age, education level, marital status, living conditions, time to diagnosis, hospitalization history, suicidal thoughts or attempts, and medication use.

Time frame
1.5 years
3

Difficulties in Emotion Regulation Scale (DDRS)

Difficulties in Emotion Regulation Scale (DDRS): Developed by Gratz and Roemer (2004), this self-assessment scale aims to identify difficulties in emotion regulation. Consisting of 36 items, this scale has six sub-dimensions: awareness, clarity, acceptance, strategy, drive, and goals. It provides a five-point Likert-type measurement. Higher scores indicate which dimension experiences more difficulty. The Turkish adaptation and validity-reliability study were conducted by Rugancı and Gençöz in 2010. The Cronbach's alpha reliability coefficient of the scale was calculated as 0.85, and for the sub-dimensions it ranged from 0.75 to 0.90. Test-retest reliability was calculated as 0.83, and for the subscales it ranged from 0.60 to 0.85.

Time frame
1.5 years

Other outcomes

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