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Bipolar Affective Disorder; Remission inNCT07748910

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

A study testing CBT-Based Psychological Resilience Enhancement Program for Individuals with BD in people with Bipolar Affective Disorder; Remission in, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Bipolar Affective Disorder; Remission in
What is being tested?
CBT-Based Psychological Resilience Enhancement Program for Individuals with BD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 May 2021to 3 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sivas Numune Hospital

    Sivas, Sivas, 58000

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Being tested
CBT-Based Psychological Resilience Enhancement Program for Individuals with BD
Keywords
bipolar disorder, CBT, resilience, quality of life, psychiatric nurse
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-Based Psychological Resilience Enhancement Program for Individuals with BDBehavioural

    Also called Intervention group

    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.

Study groups in NCT07748910
Study groupRoleWhat they receive
Standard TreatmentNo interventionThe 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 ProgramExperimentalThe 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
Receives: Behavioral: CBT-Based Psychological Resilience Enhancement Program for Individuals with BD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, 9 week and 21. week

  2. 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

    Measured: Baseline, 9. week and 21. week

  3. 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

    Measured: Baseline, 9. week and 21. week

  4. 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

    Measured: Baseline, 9. week and 21. week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start14 May 2021
  3. Primary completion2 Apr 2023
  4. Study completion3 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748910
Sponsor's protocol ID
13.11.2019-2019-11/22
Status last verified
Aug 2023
First submitted
23 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 29905660
  • Vieta E, Berk M, Schulze TG, Carvalho AF, Suppes T, Calabrese JR, Gao K, Miskowiak KW, Grande I. Bipolar disorders. Nat Rev Dis Primers. 2018 Mar 8;4:18008. doi: 10.1038/nrdp.2018.8.

    PubMed 29516993
  • Tse S, Murray G, Chung KF, Davidson L, Ng KL, Yu CH. Exploring the recovery concept in bipolar disorder: a decision tree analysis of psychosocial correlates of recovery stages. Bipolar Disord. 2014 Jun;16(4):366-77. doi: 10.1111/bdi.12153. Epub 2013 Nov 22.

    PubMed 24261315
  • Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21.

    PubMed 25443423
  • 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.

    PubMed 21279454
  • Scott J, Paykel E, Morriss R, Bentall R, Kinderman P, Johnson T, Abbott R, Hayhurst H. Cognitive-behavioural therapy for severe and recurrent bipolar disorders: randomised controlled trial. Br J Psychiatry. 2006 Apr;188:313-20. doi: 10.1192/bjp.188.4.313.

    PubMed 16582056
  • 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.

    PubMed 17064434
  • 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.

    PubMed 27185483
  • 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.

    PubMed 27400701
  • 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.

    PubMed 23182591
  • 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.

    PubMed 28992535
  • Echezarraga A, Las Hayas C, Gonzalez-Pinto AM, Jones S. The Resilience Questionnaire for Bipolar Disorder: Development and validation. Arch Psychiatr Nurs. 2017 Aug;31(4):376-385. doi: 10.1016/j.apnu.2017.04.010. Epub 2017 Apr 24.

    PubMed 28693874
  • Cohen AN, Hammen C, Henry RM, Daley SE. Effects of stress and social support on recurrence in bipolar disorder. J Affect Disord. 2004 Oct 1;82(1):143-7. doi: 10.1016/j.jad.2003.10.008.

    PubMed 15465589
  • 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.

    PubMed 25243746
  • 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.

    PubMed 29777563

Questions about this trial

What is this clinical trial studying?

A study testing CBT-Based Psychological Resilience Enhancement Program for Individuals with BD in people with Bipolar Affective Disorder; Remission in, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Connor-Davidson Resilience Scale (CD-RISC) (time frame: Baseline, 9 week and 21. week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07748910, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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