Acceptance and Commitment Therapy Principles for Diabetes Prevention

NCT05260983 | Completed

• 1 other identifier: STUDY00000198
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• (Modified) Brief Diabetes Risk-Related Distress

  The Diabetes Risk Distress Scale is a 5-item survey designed to measure patient concerns about diabetes prevention efforts and emotional burden of diabetes risk. The scale is modified for use in populations at high-risk of developing diabetes from the Brief Diabetes Distress Scale, with the inclusion of an additional item from the original 17-item Diabetes Distress Scale . Responses are collected using a 6-point likert scale ranging from "Not a problem" (1) to "A Very Serious Problem" (6), with higher scores reflecting higher levels of diabetes distress. Two subscales will also be considered: emotional burden and diabetes distress.

  Directly following the intervention

• Brief Illness Perceptions Questionnaire

  The Brief Illness Perceptions Questionnaire is a 9-item survey to rapidly assess the cognitive and emotional representations of illness tailored to focus on illness perceptions regarding diabetes risk. There are 5 items to measure cognitive representation of illness perceptions: consequences, timeline, personal control, treatment control, identity; two items to measure emotional representation: concern and emotional response; one item to measure illness comprehensibility / understanding; and one item designed to assess causal representation which asks participants to "rank-order the three most important factors that \[the participant\] believe caused \[the participants\] diabetes risk." Responses for the first 8 items are collected on an eleven-point Likert scale (e.g. Not at all affected emotionally (0) to Extremely affected emotionally (10)), where higher scores reflect a more extreme illness perception. Causal representation is an open-ended response.

  Directly following the intervention

• Expected Diabetes Prevention-Related Controllability Awareness Scale

  The Expected Diabetes Prevention-Related Controllability Awareness Scale is a 20- item survey designed to measure ''controllability awareness,": the extent to which the individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. The inventory was developed to assess controllability awareness as a characteristic of stress tolerance. The inventory consists of 20 simple statements assessing awareness of various aspects of controllability including personal control, shared control, others in control, and no one in control. Subjects indicate how much they agree or disagree with each statement from 1 = disagree strongly to 5 = agree strongly. Scores from all items are summed for a scoring running from 20-100, where higher scores reflect higher levels of controllability awareness.

  Directly following the intervention

• Expected Program-Related Controllability Awareness Scale

  The Expected Program-Related Controllability Awareness Scale was created to measure ''controllability awareness',": how much an individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. . Participants are provided a description of controllability awareness and then about the degree to which they agree with the statement "A diabetes prevention program like this one would help me prevent diabetes by teaching me to pay attention to the things about my situation that I can change and the things about my situation that I cannot change". Subjects indicate how much they agree or disagree with the statement on a 5-point scale from 1 = disagree strongly to 5 = agree strongly, where higher scores reflect higher controllability awareness.

  Directly following the intervention

• Personalized Psychological Flexibility Index-Diabetes Prevention

  The Personalized Psychological Flexibility Index-Diabetes Prevention is a 15-item survey designed to measure the ability to pursue valued life aims despite the presence of distress, which is a fundamental contributor to health. The index measures tendencies to avoid, accept, and harness discomfort during valued goal pursuit. For this study, we modified the scale to tailor the wording to goals related to diabetes prevention. In this study, three subscales are calculated: Avoidance subscale, Acceptance subscale, and Harnessing subscale. Items are measured on a 7 point likert scale of "strongly disagree" (1) to "strongly agree" (7). Psychological flexibility scores are computed by summing all items and range from 15-105, with higher scores reflecting more challenge in pursuing valued life goals despite presence of distress.

  Directly following the intervention

• Brief Health Belief Model

  The Brief Health Belief Model measure is designed to assess patient beliefs about the perceived seriousness ("If someone had Type 2 Diabetes or another related disease (such as stroke or heart disease), their whole life would change"), perceived susceptibility ("It is likely that I will get Type 2 Diabetes or another related disease (such as stroke or heart disease"), perceived prevention program benefits ("If I do a lifestyle change program for diabetes prevention it will decrease my chances of getting Type 2 Diabetes"), confidence ("I am confident that I could do what is recommended in the Diabetes Prevention Program if I wanted to"), and health motivation ("Maintaining good health is extremely important to me"). Each item is scored from 1 to 5 based on a Likert scale: "I strongly disagree" (1 point), "I disagree" (2 points), "I am not sure" (3 points), "I agree" (4 points), and "I strongly agree" (5 points).

  Directly following the intervention

• Phenomenological Body Shame Scale - Revised

  The Phenomenological Body Shame Scale - Revised is an 8 item survey derived from the original 18 item Phenomenological Body Shame Scale designed to measure the motivational and behavioral components of experiencing shame when participants imagine looking at themselves in a mirror, such as the desire to hide, escape, or disappear. Sample statements include "These diabetes education materials made me feel like covering my body." and "These diabetes education materials made me wish I were invisible." and are measured on a 5 point likert scale ranging from "not at all" scored as 1 to "extremely" scored as 5. Possible scores range from 8 to 40 with higher scores reflecting higher body shame.

  Directly following the intervention

Secondary Outcomes (2)

• (Modified) 3-item Positive and Negative Affect

  Directly following the intervention

• Short-form State-Trait Anxiety Inventory

  Directly following the intervention

Other Outcomes (4)

• Treatment Expectations and Intentions to Engage

  Directly following the intervention

• Contemplation Ladder

  Directly following the intervention

• (Modified) Brief Patient Activation Measure

  Directly following the intervention

Study Arms (2)

Diabetes Prevention Education Only

ACTIVE COMPARATOR

A brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Diseases Control and Prevention's National Diabetes Prevention Program.

Behavioral: Diabetes Prevention Education Only

Diabetes Prevention Education and Acceptance and Commitment Therapy

EXPERIMENTAL

A brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging 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.

Behavioral: Diabetes Prevention Education and Acceptance and Commitment Therapy

Interventions

Diabetes Prevention Education and Acceptance and Commitment Therapy BEHAVIORAL

A brief diabetes prevention education and acceptance and commitment therapy engagement facilitation intervention. Acceptance and Commitment Therapy-informed materials (i.e. video, workbook, and activities) will retain facts about the condition, but will modify health messaging 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.

Diabetes Prevention Education and Acceptance and Commitment Therapy

Diabetes Prevention Education Only BEHAVIORAL

A brief standard diabetes prevention education engagement facilitation intervention modeled from the Center for Disease Control and Preventions's National Diabetes Prevention Program.

Diabetes Prevention Education Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• United States Residency
• % 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).
• At least 18 years of age
• English-speaking
• High-risk for Type 2 Diabetes, as indicated by a score of 5 or greater on the American Diabetes Association's diabetes risk test.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

University of Oregon - Social Affective Neuroscience Lab

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• Lipsett M, Berkman E. A randomized controlled trial of an acceptance and commitment therapy-informed diabetes prevention program reduces body shame and distress. Health Psychol. 2025 May;44(5):549-559. doi: 10.1037/hea0001434.

  PMID: 40232790 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: March 2, 2022
• Study Start: August 28, 2021
• Primary Completion: September 4, 2021
• Study Completion: September 21, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)