Narrative Enhancement and Cognitive Therapy for Bipolar Disorder

Overseen By Abigail Amartey, MPH MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Recent hospitalization, New psychotherapy, Communication issues

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot clinical trial is to assess the feasibility of conducting a full-scale study to learn if a new youth-adapted Narrative Enhancement and Cognitive Therapy (NECT-Y) reduces self-stigma in youth living with bipolar disorder or multiple mental health conditions. The main questions it aims to answer are:

* What is the feasibility of conducting a definitive clinical trial in terms of recruitment success, study retention/compliance, treatment retention/compliance, and absence of serious adverse events?

* Can facilitators deliver the adapted NECT-Y intervention with fidelity?

* What is the acceptability of the newly adapted NECT-Y intervention among youth participants and facilitators?

Researchers will compare NECT-Y to treatment as usual (TAU).

Participants will take part in a virtual 14-week NECT-Y group intervention or receive TAU. They will also complete questionnaires at three time points (baseline, post-treatment, and follow-up).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the study compares the new therapy to treatment as usual.

How is the treatment Narrative Enhancement and Cognitive Therapy (NECT) different from other treatments for bipolar disorder?

Narrative Enhancement and Cognitive Therapy (NECT) is unique because it focuses on improving personal narratives and cognitive processes, which can help patients with bipolar disorder better understand and manage their condition. Unlike standard cognitive therapies, NECT emphasizes enhancing personal stories and self-perception, which may be particularly beneficial for those who struggle with self-identity and emotional regulation. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Narrative Enhancement and Cognitive Therapy for Bipolar Disorder?

Research suggests that cognitive-behavioral therapy, which shares elements with Narrative Enhancement and Cognitive Therapy, can improve mood symptoms and increase self-control in people with bipolar disorder. Additionally, schema therapy, another similar approach, may help reduce emotional reactivity and improve quality of life for those with bipolar disorder. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisa Hawke, PhD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for young people with bipolar disorder or multiple mental health conditions who experience self-stigma. They must understand and agree to the study's procedures, have not started new psychotherapy in the last month, and haven't had a recent hospital visit for mental health.

Inclusion Criteria

Must sign and date the informed consent form

Stated willingness to comply with all study procedures

I have been diagnosed with bipolar disorder or have multiple mental health conditions.

Exclusion Criteria

I started a new psychotherapy within the last month.

I have not been hospitalized or visited the emergency department for mental health issues in the last 30 days.

I am able to give consent and communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months

Treatment

Participants receive the NECT-Y intervention or Treatment as Usual (TAU) for 14 weeks

14 weeks

Virtual sessions for NECT-Y participants

Post-treatment Assessment

Participants complete post-treatment assessments and questionnaires

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 3-month follow-up assessment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Narrative Enhancement and Cognitive Therapy

Trial Overview The trial tests if Narrative Enhancement and Cognitive Therapy (NECT-Y) can reduce self-stigma better than usual care. Participants will join a virtual 14-week NECT-Y group or receive their regular treatment while completing questionnaires at different stages.

How Is the Trial Designed?

Group I: NECT-Y Experimental Treatment 1 Intervention

Virtual 14-week Narrative Enhancement and Cognitive Therapy group intervention that will be co-facilitated by a clinician and peer support worker.

Group II: Treatment as usual Placebo Group 1 Intervention

No study-specific care will be provided to these participants.

Narrative Enhancement and Cognitive Therapy is already approved in United States for the following indications:

Approved in United States as NECT for:

• Reducing self-stigma in adults with mental health challenges

Approved in United States as NECT-Y for:

• Reducing self-stigma in youth living with bipolar disorder or multiple mental health conditions

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Lawson Health Research Institute

Collaborator

Trials

684

Recruited

432,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Collaborator

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

668

Recruited

424,000+

Published Research Related to This Trial

Schema therapy (ST) is proposed as a promising adjunctive psychotherapy for bipolar disorder, which is characterized by complex and chronic psychological issues.

If effectively tailored to bipolar disorder, ST could help reduce emotional reactivity, alleviate symptoms, and enhance the overall quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schema therapy for bipolar disorder: a conceptual model and future directions. Hawke, LD., Provencher, MD., Parikh, SV.[2018]

Cognitive behavior therapy (CBT) shows promise as a beneficial adjunct to medication for patients with bipolar disorder, emphasizing a collaborative and educational approach that empowers patients to take an active role in their treatment.

Preliminary studies suggest that CBT may improve outcomes for bipolar disorder, but further randomized controlled trials are necessary to confirm its effectiveness compared to standard treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy as an adjunct to medication in bipolar disorder. Scott, J.[2019]

Psychosocial treatments for bipolar disorder, such as family-focused psychoeducation and individual psychotherapy, can enhance the effectiveness of outpatient pharmacotherapy by improving patient adherence and support from their social environment.

Early results from ongoing clinical trials indicate high retention rates for patients undergoing these therapies, suggesting they are well-received and may be beneficial when combined with standard medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New psychosocial treatments for the outpatient management of bipolar disorder. Miklowitz, DJ., Frank, E., George, EL.[2009]

In a study of 54 bipolar I patients, those with a high 'sense of hyper-positive self' (SHPS) were more likely to prefer a manic internal state and engage in behaviors that could lead to mania, indicating a potential risk factor for relapse.

The findings suggest that clinicians should focus on modifying goal-attainment beliefs in patients exhibiting SHPS traits, using cognitive restructuring techniques to help manage their tendency to identify with hypomanic characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sense of hyper-positive self, goal-attainment beliefs and coping strategies in bipolar I disorder. Lee, R., Lam, D., Mansell, W., et al.[2018]

Cognitive therapy for bipolar disorder has shown mixed results in randomized controlled trials, highlighting the need for a deeper understanding of cognitive profiles associated with the condition.

Negative cognitive styles are linked to depressive episodes in bipolar disorder, while positive cognitive styles, such as goal focus and increased confidence, are observed during manic states, suggesting that treatment approaches may need to address both aspects for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar disorder: what can psychotherapists learn from the cognitive research? Johnson, S., Tran, T.[2018]

In a study involving 345 participants, including 106 with bipolar disorder, it was found that while emotional imagery quality was similar across groups, the appraisals of imagery significantly differed, particularly between those with and without mood disorders.

Imagery was reported to amplify emotions in all groups, but only individuals with bipolar disorder experienced this amplification as influencing their behavior, especially during manic or depressed states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. van den Berg, KC., Voncken, M., Hendrickson, AT., et al.[2023]

The paper outlines a schema therapeutic model for treating bipolar disorder (BD), emphasizing seven effective psychosocial intervention elements, such as mood monitoring, stress management, and relapse prevention planning.

It highlights the need for further research into schema therapy for BD, suggesting that integrating psychosocial strategies with traditional treatments could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schema Therapy for Patients with Bipolar Disorder: Theoretical Framework and Application. Ociskova, M., Prasko, J., Kantor, K., et al.[2022]

A modified cognitive-behavioral therapy (CBT) approach applied to seven individuals after their first diagnosis of bipolar disorder showed significant improvements in mood symptoms and feelings of hopelessness.

Participants also demonstrated better self-control, more stable daily activities, and improved skills in recognizing and coping with early warning signs of mood episodes, suggesting that early intervention with CBT may enhance long-term outcomes in bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural treatment of first diagnosis bipolar disorder. Jones, SH., Burrell-Hodgson, G.[2018]

Women with remitted bipolar disorder (BD) reported their past life stories with less sense of agency and communion, and more negative experiences (contamination) compared to non-clinical controls, indicating a different narrative identity.

Interestingly, the future life stories of BD patients did not show significant differences from those of the control group, suggesting that while their past experiences are affected, their hopes or plans for the future may remain similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"My life disappeared in illness": bipolar disorder and themes in narrative identity. Pedersen, AM., Straarup, KN., Thomsen, DK.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

"My life disappeared in illness": bipolar disorder and themes in narrative identity. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioural treatment of first diagnosis bipolar disorder. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

New psychosocial treatments for the outpatient management of bipolar disorder. [2009]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Schema therapy for bipolar disorder: a conceptual model and future directions. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Schema Therapy for Patients with Bipolar Disorder: Theoretical Framework and Application. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive therapy as an adjunct to medication in bipolar disorder. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Bipolar disorder: what can psychotherapists learn from the cognitive research? [2018]

8. England pubmed.ncbi.nlm.nih.gov

Sense of hyper-positive self, goal-attainment beliefs and coping strategies in bipolar I disorder. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring aspects of self-reported emotional mental imagery in patients with bipolar disorder. [2023]