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临床试验/NCT07748910
NCT07748910已完成不适用

Impact of Resilience Improvement Program on Resilience and Quality of Life of Patients Diagnosed With Bipolar Disorder

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Connor-Davidson Resilience Scale (CD-RISC)

研究概览

简要总结

Bipolar disorder (BD) is a chronic and recurrent mood disorder characterized by alternating episodes of mania, depression, or mixed states, interspersed with periods of remission. These episodes can severely impair interpersonal relationships, occupational functioning, and overall quality of life. In 2019, approximately 40 million people worldwide were diagnosed with BD.

BD is a lifelong chronic condition despite pharmacotherapy and lifestyle changes. Traditional psychiatric care has primarily focused on symptom reduction and relapse prevention, often overlooking broader psychosocial aspects such as interpersonal functioning and life satisfaction. Recently, recovery has come to include living a meaningful life despite illness-related challenges.

Psychological resilience has gained prominence within this recovery framework. It refers to the capacity to adapt positively to adversity, shaped by both internal traits and external supports. Core elements include effective coping, adaptability, and recovery from stress, which support functional outcomes in mental illness.

Given the strong link between stress and relapse in BD, resilience is thought to play a critical role in illness trajectory. Research consistently shows that individuals with BD have lower resilience than healthy controls, and resilience is associated with fewer depressive symptoms and better quality of life.

Importantly, resilience is modifiable and can be enhanced through psychosocial interventions. Studies highlight the benefits of resilience-building programs in reducing depressive vulnerability and improving life satisfaction and emotion regulation. Among these, CBT effectively promotes cognitive and functional recovery in BD by targeting maladaptive thought patterns and building adaptive coping skills.

Despite growing evidence, few CBT-based interventions target resilience in individuals with BD. However, resilience is linked to key psychosocial competencies such as problem-solving, self-efficacy, assertiveness, and self-management. Based on this, the current study implemented a CBT-based Psychological Resilience Enhancement Program designed to strengthen adaptive coping and functional adjustment in individuals with BD.

Considering the substantial personal and societal burden of BD, enhancing psychological resilience is a critical therapeutic goal. This study aimed to evaluate the effects of a CBT-based intervention on psychological resilience and quality of life in individuals with BD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

A randomized controlled trial with a pretest-posttest-follow-up design was conducted between May 2021 and April 2023. Twenty-two participants were randomly assigned to an intervention group (n = 10), which completed an eight-week CBT-based resilience program, or a control group (n = 12), which received standard care. Psychological resilience and quality of life were assessed at baseline, post-intervention (week 9), and follow-up (week 21) using the Connor-Davidson Resilience Scale (CD-RISC) and the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD).

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 60 years
  • Minimum of primary school education
  • Ability to communicate verbally
  • Score ≤ 5 on the YMRS
  • Score ≤ 17 on the BDI
  • Residence within the city center
  • Voluntary participation with signed informed consent

排除标准

  • Diagnosis of intellectual disability
  • Speech or hearing impairment
  • Presence of comorbid psychiatric disorders

研究组 & 干预措施

Standard Treatment

No Intervention

The control group simply continued treatment. In Türkiye, standard treatment consists of medication use, prescriptions every three to six months, and outpatient check-ups for laboratory tests such as drug levels. In the study, however, patients in the control group were interviewed, their questions about their illness and treatment were answered, and their general condition was assessed. Treatment adherence levels were determined based on their remission status. It consists of a total of 12 individuals with bipolar disorders

Resilience Improvement Program

Experimental

The intervention is based on the assumption that individuals with high psychological resilience cope better with psychosocial stressors, return to normal life more quickly after stressful events, adapt more easily to new situations, and can continue their lives even under difficult circumstances. An individual diagnosed with bipolar disorder who increases their psychological resilience will both prevent the triggering of attacks and gain skills to manage the symptoms of the illness. The program was designed focusing on areas emphasized in resilience theory, which can be developed and modified through education and life experience, and which also fall within the scope of cognitive behavioral therapy. These are internal locus of control, self-management, cognitive evaluation, social skills, social support, positive mood, stress management, and problem-solving skills. The intervention was each targeting specific therapeutic goals using relevant CBT techniques in 8weekly

干预措施: CBT-Based Psychological Resilience Enhancement Program for Individuals with BD (Behavioral)

结局指标

主要结局

Connor-Davidson Resilience Scale (CD-RISC)

时间窗: Baseline, 9 week and 21. week

Connor-Davidson Resilience Scale (CD-RISC): Developed by Connor and Davidson in 2003 to measure individuals' psychological resilience, this scale primarily focuses on stress, coping, and adaptability. It is a 25-item, five-point Likert-type scale, with each item evaluated between 0 and 4, ranging from "not true at all" (0 points) to "true nearly all the time" (4 points). The maximum achievable score on the scale is 100. Higher scores denote greater psychological resilience, whereas lower scores indicate reduced resilience. During its development phase, the scale was administered to both normative and clinical populations. Data collected face-to-face via clinical interview

Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD)

时间窗: Baseline, 9. week and 21. week

Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD): Developed by Michalak and Murray (2010) to evaluate the quality of life in patients with bipolar disorder. It is a 12-item quality of life scale specifically designed for bipolar disorder. It comprises one item for each of the following core domains: physical health, sleep, mood, cognition, leisure, social relationships, spirituality, finances, household, self-esteem, independence, and identity. The scale is rated on a five-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), yielding a total score between 12 and 60. Higher scores indicate a better quality of life. Data collected face-to-face via clinical interview

Beck Depression Inventory (BDI)

时间窗: Baseline, 9. week and 21. week

Beck Depression Inventory (BDI): This scale consists of 21 items designed to measure the affective, somatic, cognitive, and motivational symptoms of depression, with each item scored on a scale from 0 to 3. The total possible score ranges from 0 to 63. The assessment is based on the cumulative score obtained from all items, where higher scores indicate greater depression severity. In the present study, the BDI was utilized to verify the remission status required for the inclusion of patients diagnosed with bipolar disorder. Patients who scored 17 or lower on the inventory were included in the research. Data collected face-to-face via clinical interview

Young Mania Rating Scale (YMRS)

时间窗: Baseline, 9. week and 21. week

Young Mania Rating Scale (YMRS): Developed by Young et al. in 1978, this scale is utilized to assess the severity of manic states. It comprises 11 Likert-type items, each assessing symptom severity across five levels. The total score ranges from 0 to 60, with higher scores denoting increased mania severity. In the current study, the YMRS was employed to confirm the remission status necessary for the inclusion of patients with bipolar disorder. Patients obtaining a score of 5 or lower on the scale were eligible for inclusion. Data collected face-to-face via clinical interview

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Aksoy, Dr

Doctor, (Phd. Psychiatric Nurse)

Cumhuriyet University

研究点 (1)

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