Self-Affirmation for Diabetes

Overseen By Elizabeth Scharnetzki

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elizabeth Scharnetzki

Disqualifiers: Under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

150 Participants Needed

Trial Summary

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 focused on self-affirmation exercises and does not mention changes to medication.

What data supports the effectiveness of the treatment Self-Affirmation for Diabetes?

Research shows that self-affirmation can help people with chronic conditions like cardiopulmonary disease and chronic pain improve their health behaviors and outcomes. This suggests that self-affirmation might also be beneficial for people with diabetes by encouraging positive behavior changes and improving emotional well-being. ^{1 2 3 4 5}

Is self-affirmation therapy safe for humans?

There is no specific safety data available for self-affirmation therapy, but studies on similar interventions like physical activity programs show that serious adverse events are rare, with only minor issues like muscle injuries reported. These studies suggest that starting slowly and gradually increasing intensity can help ensure safety. ^{6 7 8 9 10}

How is the Self-Affirmation treatment for diabetes different from other treatments?

Self-Affirmation treatment is unique because it focuses on enhancing a person's positive self-view and motivation, which can improve their ability to manage diabetes. Unlike traditional medical treatments that focus on physical aspects, this psychological approach aims to boost self-regulation and adherence to diabetes management through personal reflection and affirmation. ^{11 12 13 14 15}

What is the purpose of this trial?

This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are: * Will self-affirmation reduce feelings of stigmatization? * Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors. * Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it. After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention.

Research Team

Elizabeth Scharnetzki

Principal Investigator

MaineHealth

Eligibility Criteria

This trial is for adults with type 2 diabetes who are already using a continuous glucose monitor. It's designed to see if self-affirmation exercises before doctor visits can help manage the emotional and psychological challenges of living with diabetes.

Inclusion Criteria

I am over 18, have type 2 diabetes, and use a continuous glucose monitor.

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete self-affirmation writing exercises before their 3-month wellness appointments

12 months

4 visits (in-person)

Follow-up

Participants are monitored for changes in stigma, self-efficacy, and glucose control

4 weeks

Treatment Details

Interventions

• Self-Affirmation

Trial Overview Participants will do writing exercises that focus on their self-worth before their regular wellness appointments over a year. The study aims to find out if these exercises reduce stigma, boost motivation for managing diabetes, and improve blood sugar control compared to those on a waitlist.

Participant Groups

Group I: Self-Affirmation Experimental Treatment 1 Intervention

Participants review a list of values and are instructed to choose up to two that are important to them. The values listed are intentionally unrelated to the threat-inducing domain so that the exercise broadens participants' focus. Next, participants are asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.

Group II: Waitlist Control Placebo Group 1 Intervention

Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.

Who Is Running the Clinical Trial?

Elizabeth Scharnetzki

Lead Sponsor

Trials

1

Recruited

150+

MaineHealth Institute for Research

Collaborator

Trials

1

Recruited

150+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Findings from Research

In a study of 768 individuals with chronic pain, self-affirmation techniques were linked to improved psychosocial health, showing reduced symptoms of depression, anxiety, and social isolation.

However, self-affirmation did not significantly impact physical health measures or pain-related outcomes, suggesting its benefits may be more psychological than physical in nature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous self-affirmation: an adaptive coping strategy for people with chronic pain. You, DS., Hettie, G., Darnall, BD., et al.[2023]

A systematic review of six controlled trials found that specific social support interventions, like group consultations and Internet-based peer support, can positively impact health outcomes for people with type 2 diabetes, improving measures like HbA1c and physical activity.

Traditional forms of social support, such as from family and friends, did not show significant improvements in diabetes control, suggesting that innovative support methods may be more effective in helping patients manage their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support in diabetes: a systematic review of controlled intervention studies. van Dam, HA., van der Horst, FG., Knoops, L., et al.[2022]

Enhancing self-efficacy in patients with chronic illnesses is crucial for promoting positive behavior change, as it is the strongest predictor of such changes according to Bandura's theory.

The paper outlines four key sources to boost self-efficacy: performance accomplishments, vicarious learning, verbal persuasion, and self-appraisal of emotional and physiological responses, along with strategies for implementing these in educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies enhancing self-efficacy in diabetes education: a review. van de Laar, KE., van der Bijl, JJ.[2022]

A week-long outpatient education program for 165 participants significantly improved emotional well-being, self-esteem, and diabetes self-efficacy, while reducing anxiety and depression, with these benefits lasting for at least 6 months.

Participants showed long-term improvements in self-care behaviors, such as increased blood glucose monitoring and exercise, and better glycemic control, indicating that targeted diabetes education can lead to sustained health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of diabetes education on self-care, metabolic control, and emotional well-being. Rubin, RR., Peyrot, M., Saudek, CD.[2019]

In a study of 756 patients with chronic cardiopulmonary disease, a positive affect and self-affirmation intervention led to greater improvements in health behaviors compared to a standard patient education control group.

The intervention not only increased positive feelings and self-efficacy but also helped patients better manage stress, resulting in more successful behavior changes like increased physical activity and medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators and moderators of behavior change in patients with chronic cardiopulmonary disease: the impact of positive affect and self-affirmation. Charlson, ME., Wells, MT., Peterson, JC., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A meta-analysis of 103 studies involving 10,455 adults with type 2 diabetes found that self-management interventions including exercise significantly improved metabolic control, with an average reduction in HbA1c of 0.45% compared to control groups.

Interventions focusing solely on exercise yielded a higher effect size (0.45) than those targeting multiple health behaviors (0.22), indicating that exercise-specific recommendations may be particularly effective for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of interventions to increase exercise in adults with type 2 diabetes. Conn, VS., Hafdahl, AR., Mehr, DR., et al.[2022]

A study involving 69 older Malays with type 2 diabetes showed that combining personalized feedback (PF) with peer support (PS) significantly increased daily physical activity levels compared to usual care, with the PS group achieving the highest pedometer readings.

The PS group also demonstrated greater improvements in various physical activity measures, including duration and frequency of moderate-intensity activity, cardiorespiratory fitness, and social support, highlighting the effectiveness of peer support in enhancing physical activity among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial. Sazlina, SG., Browning, CJ., Yasin, S.[2020]

In a study of 198 type 2 diabetes patients, a single session of toolkit-based physical activity counselling did not lead to significant changes in overall physical activity or clinical outcomes after 6 months compared to standard care.

However, patients who were initially inactive (<150 minutes of moderate-to-vigorous physical activity per week) showed a significant increase in their activity levels, suggesting that the toolkit may be beneficial for those starting from a low baseline of physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of resources to support patient physical activity through diabetes centres in Atlantic Canada: the effectiveness of toolkit-based physical activity counselling. Fowles, JR., Shields, C., Barron, B., et al.[2014]

A systematic review of 17 studies involving diabetes healthcare practitioners found that training in Motivational Interviewing (MI) consistently improved practitioners' MI skills, with 14 studies showing over 50% improvement.

To effectively maintain and enhance MI skills, training programs should incorporate education, role play, and ongoing supervision, as the effectiveness of MI application varied among practitioners post-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training diabetes healthcare practitioners in motivational interviewing: a systematic review. Kaczmarek, T., Kavanagh, DJ., Lazzarini, PA., et al.[2022]

Cognitive behavioural group training (CBGT) improved diabetes self-efficacy, reduced diabetes-related distress, and decreased depressive symptoms in Type 1 diabetes patients, but did not lead to significant changes in glycaemic control (HbA1c levels).

The study involved 107 participants over a 6-week intervention period, and while both CBGT and the control group (blood glucose awareness training) showed similar improvements in psychological outcomes, the drop-out rate was higher in the CBGT group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of cognitive behavioural group training (CBGT) in adult Type 1 diabetes patients in prolonged poor glycaemic control. A randomized controlled trial. van der Ven, NC., Hogenelst, MH., Tromp-Wever, AM., et al.[2022]

Psychological interventions, such as cognitive behavioral training and counseling, have been shown to significantly reduce glycated hemoglobin levels in Type 2 Diabetes Mellitus patients, indicating improved metabolic control.

These interventions serve as effective adjuncts to standard medical treatments, enhancing self-regulation, disease awareness, and patient adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological interventions for patients with type 2 diabetes mellitus. A systematic review and meta-analysis]. González-Burboa, A., Acevedo Cossio, C., Vera-Calzaretta, A., et al.[2020]

A study involving 9 adult diabetics over 5 months showed that group sessions focusing on psycho-affective aspects of diabetes led to improved self-awareness and acceptance of their condition.

Participants exhibited better technical management of their diabetes, indicating that addressing emotional and psychological factors can enhance diabetes self-monitoring behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A broad educational approach to insulin-dependent diabetics]. de Poret, D., Pouliquen, A., Dejours, C., et al.[2007]

A 12-week program for 29 individuals with diabetes and blindness significantly improved glycemic control, with glycated hemoglobin levels decreasing from 13.0% to 11.4%.

Participants also showed enhanced physical fitness and psychosocial well-being, including improved exercise tolerance and self-esteem, as indicated by various mental health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model clinical program for patients with diabetes and vision impairment. Bernbaum, M., Albert, SG., Brusca, SR., et al.[2017]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Spontaneous self-affirmation: an adaptive coping strategy for people with chronic pain. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Social support in diabetes: a systematic review of controlled intervention studies. [2022]

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

Strategies enhancing self-efficacy in diabetes education: a review. [2022]

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

Effect of diabetes education on self-care, metabolic control, and emotional well-being. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Mediators and moderators of behavior change in patients with chronic cardiopulmonary disease: the impact of positive affect and self-affirmation. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Metabolic effects of interventions to increase exercise in adults with type 2 diabetes. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Implementation of resources to support patient physical activity through diabetes centres in Atlantic Canada: the effectiveness of toolkit-based physical activity counselling. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Training diabetes healthcare practitioners in motivational interviewing: a systematic review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Short-term effects of cognitive behavioural group training (CBGT) in adult Type 1 diabetes patients in prolonged poor glycaemic control. A randomized controlled trial. [2022]

13. Chile pubmed.ncbi.nlm.nih.gov

[Psychological interventions for patients with type 2 diabetes mellitus. A systematic review and meta-analysis]. [2020]

14. France pubmed.ncbi.nlm.nih.gov

[A broad educational approach to insulin-dependent diabetics]. [2007]

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

A model clinical program for patients with diabetes and vision impairment. [2017]