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An Acceptance and Commitment Therapy (ACT) program for individuals living with type 1 diabetes did not impact their hemoglobin (HbA1c) significantly, according to new findings, though it showed persistent benefits regarding patients’ psychological flexibility.¹

The ACT program—an expansion on Cognitive Behavioral Therapy (CBT)—was designed with the goal of type 1 diabetes patients avoiding suppression of their negative feelings, especially given the severity of the disease and the prevalence of impaired psychological health.

The investigators of this study noted that prior studies on implementation of ACT for those with diabetes had primarily been aimed at type 2 diabetes patients.² The new study on type 1 patients was led by Ingrid Wijk, from the Department of Health Promoting Science at Sophiahemmet University in Stockholm, Sweden.

“Our hypothesis was that an ACT programme would lead to improvements in glycaemic and psychosocial outcomes in an adult population with type 1 diabetes and prolonged elevation of HbA1c,” Wijk and colleagues wrote. “Thus, we conducted an RCT aiming to evaluate the impact of an ACT programme, tailored for people living with type 1 diabetes, on HbA1c, self-management and psychosocial factors.”

Background and Findings

The investigators held their longitudinal, 2-arm, randomized controlled trial (RCT) at a Swedish endocrinology clinic. Their research involved an intervention arm taking part in an ACT program and a control arm being given what was described as treatment-as-usual (TAU).

The study participants were identified by the investigators through the use of the Swedish National Diabetes Register. The research team’s criteria they required for inclusion held that participants had to have type 1 diabetes and a duration of 2 years minimum, as well as being in the age range of 18–70 years with HbA1c>60 mmol/mol on 2 occasions within the prior year.

Exclusion criteria included inability of participants to speak Swedish, participants having an untreated or severe psychiatric disease which is ongoing, treatment with cortisone, having an untreated thyroid disease, and using insulin pump therapy that had been occurring since <3 months.

The investigators’ power analysis showed a need for at least 56 subjects to detect a clinically relevant HbA1c reduction. The team had more than 5 rounds from 2016 - 2019, with 622 subjects that had HbA1c>60 mmol/mol being assessed and 23.6% meeting the inclusion criteria and giving their written informed consent.

After taking baseline sociodemographic and treatment data, the research team randomly assigned participants to either the intervention or control cohort. They ensured equal sex distribution through the use of stratification, and their randomization process was conducted by an impartial investigator implementing sealed lots.

Blinding of either the instructors of the ACT or the research assistant nurses for group assignments was not shown to be feasible. Nevertheless, the ACT instructors did not interact with the control arm of the study, and the research nurse assistant was not involved in the intervention program and did not have the skills required for interacting with the ACT program.

The intervention used in the ACT was made up of seven 2-hour sessions which lasted for a total of 14 weeks, and they emphasized the acceptance of subjects’ stressful feelings while promoting the importance of value-based and committed actions. The team determined HbA1c as their research’s primary outcome, with secondary outcomes determined to be measures of anxiety, self-care activities, depression, general forms of stress, hypoglycemia fears, distress linked to diabetes, subjects’ psychological flexibility, and their quality of life.

The investigators’ primary endpoint determined for their assessments was HbA1c by the 2-year mark following intervention. They utilized linear mixed models so that they could assess the interaction effect observed between measurement time and participant group.

The research team reported, following their likelihood ratio test of nested models, that they could find no statistically significant interaction effect (χ2=0.49, P=0.485) between measurement time and participant group related to HbA1c.

While this was the case, the team did note an interaction effect which was shown to be statistically significant (likelihood ratio test χ2=12.63, P<0.001). They added that this indicated improved scores on subjects’ Acceptance and Action Questionnaire, measuring psychological flexibility, among those in the intervention arm of the study following 1 and 2 years.

“In conclusion, this study showed no statistically significant difference between the groups regarding the primary outcome measure, HbA1c,” they wrote. “However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group.”

References

1. ^{Wijk I, Amsberg S, Johansson U, et al. Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial. BMJ Open. December 14, 2023. https://doi.org/10.1136/bmjopen-2023-072061. Date accessed: December 19, 2023.}
2. ^{Sakamoto R, Ohtake Y, Kataoka Y, et al. Efficacy of acceptance and commitment therapy for people with type 2 diabetes: systematic review and meta-analysis. J Diabetes Investig 2022;13:262–70. doi:10.1111/jdi.13658.}