Single-Session Depression Intervention for Youth with Type 1 Diabetes
This study is looking at whether a single-session behavioral intervention can help teenagers (ages 12-17) with Type 1 Diabetes (T1D) who are also experiencing symptoms of depression. The intervention, called "T1D-specific depression SSI," teaches about depression, how thoughts and feelings are connected, and helps identify important life areas. Participants will be compared to a group receiving educational materials about T1D. The researchers want to see if this intervention is practical, helpful to patients, and if it can improve mood and blood sugar control (measured by HbA1c). You might be able to join if you have T1D for at least 6 months, have shown signs of depression in the past year, and are not currently in mental health therapy. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 80 participants. It compares a T1D-specific depression intervention to T1D educational materials.
- What's involved
- You would participate in either the T1D-specific depression SSI or receive T1D educational materials. Your HbA1c and mood will be measured at the start, 3 months, and 6 months, with an additional mood assessment around the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after the start of the study, with some assessments occurring 7 days before and after the intervention.
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Adapting Single Sessions Interventions for Type 1 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Hemoglobin A1c (HbA1c)0, 3-months, and 6-months
Proxy measure of glycemic level. HbA1c is the average blood glucose level over 3-4 months. We will use fingerstick blood samples and a valid mail-in dried blood spot kit to measure participant HbA1c levels at a central laboratory
- Patient Health Questionnaire for Adolescents (PHQ-9)0, 3-months, and 6-months
The PHQ-9 is a well-validated and reliable measure that assesses the occurrence of nine possible depressive symptoms over the previous two weeks. Higher scores indicate greater depressive symptoms. A cut-off score of \>5 will be used to characterize elevated depressive symptoms
- Positive and Negative Affect Schedule (PANAS)7 days before and 7 days after SSI
The PANAS is a 20-item measure that assesses different feelings and emotions. Items are grouped into the two subscales with 10 items each: positive affect and negative affect, with higher scores on the Positive Affect subscale indicating greater intensity of positive emotions, and higher scores on the Negative Affect subscale indicating greater intensity of negative emotions.
- Mood and Feelings Questionnaire (MFQ)7 days before and 7 days after SSI
The MFQ is a 13-item measure that assesses depressed mood in youth. Higher scores indicate higher depressed mood.
- Feasibility of T1D-specific Depression SSIBaseline and 3-months
We will determine feasibility by calculating study enrollment rates for the Aim 2 pilot trial. We will also assess the feasibility of the type 1 diabetes (T1D)-specific depression single-session intervention (SSI) in the qualitative interviews
- Acceptability of Healthcare Interventions Questionnaireimmediately after SSI completion
The Acceptability of Healthcare Interventions Questionnaire is an 8-item measure that assesses the acceptability of healthcare interventions. Respondents rate each question on a scale of 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater intervention acceptability.