Enhancing Resilience and Quality of Life in Bipolar Disorder Through Cognitive Behavioral Therapy

NCT07748910 | Completed DMC

• 1 other identifier: 13.11.2019-2019-11/22
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Affective Disorder; Remission in

Keywords

bipolar disorder; CBT; resilience; quality of life; psychiatric nurse

Outcome Measures

Primary Outcomes (4)

• Connor-Davidson Resilience Scale (CD-RISC)

  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

  Baseline, 9 week and 21. week

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

  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

  Baseline, 9. week and 21. week

• Beck Depression Inventory (BDI)

  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

  Baseline, 9. week and 21. week

• Young Mania Rating Scale (YMRS)

  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

  Baseline, 9. week and 21. week

Study Arms (2)

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

Behavioral: CBT-Based Psychological Resilience Enhancement Program for Individuals with BD

Interventions

CBT-Based Psychological Resilience Enhancement Program for Individuals with BD BEHAVIORAL

Session 1 (Psychoeducation): Enhancing knowledge and insight regarding Bipolar Disorder via Socratic questioning and case formulation. Session 2 (Locus of Control): Shifting belief from external determinism to an internal locus of control using pie charts and didactic instruction. Session 3 (Self-Management): Acquiring skills to manage early warning signs and high-risk behaviors. Session 4 (Coping with Stress): Developing and implementing effective coping strategies. Session 5 (Problem-Solving): Utilizing a structured approach to resolve daily life problems. Session 6 (Thoughts and Emotions): Identifying emotional reactions to stimuli using the downward arrow technique, playing devil's advocate, and imagery. Session 7 (Realistic Thoughts): Fostering cognitive flexibility through examining evidence and evaluating thought functionality. Session 8 (Social Skills): Establishing external support systems to reinforce self-esteem and self-efficacy via role-playing.

Also known as: Intervention group

Resilience Improvement Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Numune Hospital

Sivas, Sivas, 58000, Turkey (Türkiye)

Location

Related Publications (16)

• Bozikas VP, Parlapani E, Ntouros E, Bargiota SI, Floros G, Nazlidou EI, Garyfallos G. Resilience Predicts Social Functioning in Clinically Stable Patients With Bipolar Disorder. J Nerv Ment Dis. 2018 Jul;206(7):567-574. doi: 10.1097/NMD.0000000000000843.

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• Sood A, Prasad K, Schroeder D, Varkey P. Stress management and resilience training among Department of Medicine faculty: a pilot randomized clinical trial. J Gen Intern Med. 2011 Aug;26(8):858-61. doi: 10.1007/s11606-011-1640-x. Epub 2011 Jan 29.

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• Post RM, Leverich GS. The role of psychosocial stress in the onset and progression of bipolar disorder and its comorbidities: the need for earlier and alternative modes of therapeutic intervention. Dev Psychopathol. 2006 Fall;18(4):1181-211. doi: 10.1017/S0954579406060573.

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• Mizuno Y, Hofer A, Suzuki T, Frajo-Apor B, Wartelsteiner F, Kemmler G, Saruta J, Tsukinoki K, Mimura M, Fleischhacker WW, Uchida H. Clinical and biological correlates of resilience in patients with schizophrenia and bipolar disorder: A cross-sectional study. Schizophr Res. 2016 Aug;175(1-3):148-153. doi: 10.1016/j.schres.2016.04.047. Epub 2016 May 13.

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• Lee S, Lee J, Choi JY. The effect of a resilience improvement program for adolescents with complex congenital heart disease. Eur J Cardiovasc Nurs. 2017 Apr;16(4):290-298. doi: 10.1177/1474515116659836. Epub 2016 Jul 10.

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• Jones S, Mulligan LD, Higginson S, Dunn G, Morrison AP. The bipolar recovery questionnaire: psychometric properties of a quantitative measure of recovery experiences in bipolar disorder. J Affect Disord. 2013 May;147(1-3):34-43. doi: 10.1016/j.jad.2012.10.003. Epub 2012 Nov 22.

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• Hofer A, Mizuno Y, Wartelsteiner F, Wolfgang Fleischhacker W, Frajo-Apor B, Kemmler G, Mimura M, Pardeller S, Sondermann C, Suzuki T, Welte A, Uchida H. Quality of life in schizophrenia and bipolar disorder: The impact of symptomatic remission and resilience. Eur Psychiatry. 2017 Oct;46:42-47. doi: 10.1016/j.eurpsy.2017.08.005. Epub 2017 Sep 1.

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• Choi JW, Cha B, Jang J, Park CS, Kim BJ, Lee CS, Lee SJ. Resilience and impulsivity in euthymic patients with bipolar disorder. J Affect Disord. 2015 Jan 1;170:172-7. doi: 10.1016/j.jad.2014.08.056. Epub 2014 Sep 6.

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• Bowie CR, Best MW, Depp C, Mausbach BT, Patterson TL, Pulver AE, Harvey PD. Cognitive and functional deficits in bipolar disorder and schizophrenia as a function of the presence and history of psychosis. Bipolar Disord. 2018 Nov;20(7):604-613. doi: 10.1111/bdi.12654. Epub 2018 May 18.

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MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• AYŞE AKSOY, Dr.

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, (Phd. Psychiatric Nurse)

Model Details: 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). Data were analyzed using independent samples t-tests and repeated measures ANOVA. Effect sizes were calculated to assess clinical relevance.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 6, 2026
• Study Start: May 14, 2021
• Primary Completion: April 2, 2023
• Study Completion: April 3, 2023
• Last Updated: August 6, 2026

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 1 months after publication and ending 3 years after publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

TU (1)