Clinical trial NCT05260983: Acceptance and Commitment Therapy Principles for Diabetes Prevention
Official title: Preventing Type 2 Diabetes Through Using Acceptance and Commitment Therapy Principles to Target Illness Perceptions and Controllability Awareness in Educational Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Diabetes
Diabetes type2
Keywords: diabetes
diabetes-related distress
diabetes self-management
illness perceptions
acceptance and commitment therapy
controllability awareness
psychological flexibility
body size stigma
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.

Detailed description: The investigators aim for this study to represent community-based, participatory research which is accessible, effective, understandable, and minimizing of stigma. Prior to conducting the study, the investigators will develop a community advisory board, consisting of practitioners who have expertise with the development and delivery of the intervention material and study population. Advisory board members will review the study materials and provide feedback for refining the study via meetings with the Principle Investigator. In addition, the investigators will hold a focus group composed of members of the community who have prediabetes or Type 2 Diabetes and who are interested in contributing to the study design. The focus group participants will review the study materials and provide feedback for improvement in understandability, minimizing stigma, effectiveness, access and relatability to the general public. Content from the community advisory board meetings and focus group will be used to inform the study design and will not be used for dissemination of data.

For the study implementation, the investigators will distribute online questionnaires on Amazon's Mechanical Turk and use CloudResearch service to recruit participants and manage the online project. Amazon's Mechanical Turk hosts research opportunities, called Human Intelligence Tasks, to online "workers". To distribute our surveys to this participant pool the investigators will embed our Qualtrics survey link in each Human Intelligence Tasks. The description of study purpose, time commitment, and research method will be available to the online "workers" who meet the inclusion criteria set on CloudResearch.

Participants will be assessed for eligibility (see below) via a qualtrics survey sent via Amazon Mechanical turk. As the eligibility process screens for risk of diabetes and assesses perceived stress, socioeconomic indicators, health status, and state anxiety, participants will also complete an initial consent form prior to eligibility screening. This process generates three distinct participant groups: study 1 ("Randomized Control Trial"), study 2 ("Cross-Sectional") and study 3 ("Sub-study"). The summary of measures given to each group is outlined in Table 1 below.

Study 1 ("Randomized Control Trial"): Participants will complete "pre-intervention measures" to assess individual differences (diabetes risk, diabetes program prevention participation, socioeconomic status, subjective social standing, co-morbidities, health status, illness perceptions, self-efficacy, and perceived stress). Participants will be randomized into either a brief standard diabetes education intervention or a brief diabetes education and acceptance and commitment therapy intervention. Acceptance and Commitment Therapy-informed materials will retain facts about the condition, but will modify health messaging (adapted from the Center for Diseases Control and Prevention's National Diabetes Prevention Program) to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. Following, participants will complete "post-intervention measures" to assess psychosocial variables (i.e. stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, acute stress, diabetes distress, diabetes locus of control, self-efficacy, controllability awareness, psychological flexibility, and self-efficacy).

Eligibility criteria: Inclusion Criteria:

1. United States Residency
2. 90% or higher Human Intelligence Task completion ratings (ratings which are assigned by mTurk researchers to workers upon completion of a Human Intelligence Task , and to indicate quality of worker history with mTurk).
3. At least 18 years of age
4. English-speaking
5. High-risk for Type 2 Diabetes, as indicated by a score of 5 or greater on the American Diabetes Association's diabetes risk test.

Exclusion Criteria:

1. Having been enrolled in a lifestyle program for diabetes prevention presently or within the past year.
2. Type 1 Diabetes diagnosis
3. Type 2 Diabetes diagnosis

Primary outcomes:
measure: (Modified) Brief Diabetes Risk-Related Distress
timeFrame: Directly following the intervention
measure: Brief Illness Perceptions Questionnaire
timeFrame: Directly following the intervention
measure: Expected Diabetes Prevention-Related Controllability Awareness Scale
timeFrame: Directly following the intervention
measure: Expected Program-Related Controllability Awareness Scale
timeFrame: Directly following the intervention
measure: Personalized Psychological Flexibility Index-Diabetes Prevention
timeFrame: Directly following the intervention
measure: Brief Health Belief Model
timeFrame: Directly following the intervention
measure: Phenomenological Body Shame Scale - Revised
timeFrame: Directly following the intervention
Secondary outcomes:
measure: (Modified) 3-item Positive and Negative Affect
timeFrame: Directly following the intervention
measure: Short-form State-Trait Anxiety Inventory
timeFrame: Directly following the intervention
Other outcomes:
measure: Treatment Expectations and Intentions to Engage
timeFrame: Directly following the intervention
measure: Contemplation Ladder
timeFrame: Directly following the intervention
measure: (Modified) Brief Patient Activation Measure
timeFrame: Directly following the intervention
measure: 1-item Expected Diabetes Prevention Self-Efficacy Scale
timeFrame: Directly following the intervention
Locations:
city: Eugene
country: United States
facility: University of Oregon - Social Affective Neuroscience Lab
state: Oregon
Study officials:
References: