Diabetes Mellitus, Type 1NCT05925556
Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
A study testing Communal Coping Intervention in people with Diabetes Mellitus, Type 1, run by Carnegie Mellon University at 1 site in United States.
Trial summary
We plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T1D Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Communal Coping Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 1 diabetes for at least one year
- married or living with someone for at least one year who is willing to participate in the study as the study partner
- age 18 and over
- reliable access to the internet at home
Who cannot join
- Non-English speakers
- Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)
- Partner does not consent to participate in study
- Partner has diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Communal Coping Intervention for Adults With Type 1 Diabetes
We plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T1D
Read the detailed description
We will recruit 66 couples in which one person has type 1 diabetes. Power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. Couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. All couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. The intervention group will receive the communal coping intervention. Couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. After the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. During the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). An in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Communal Coping Intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communal Coping InterventionBehavioural
The components of the intervention were described in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Communal Coping Intervention | Experimental | The intervention consists of a single session brief communal coping intervention followed by 7 days of intervention prompts delivered via text message to help couples generalize what they have learned into their daily life. There are 9 components to the intervention:
1. establishment of rapport
2. shared stressor recollection
3. communal coping education
4. application of appraisal to diabetes
5. we-statements to reframe diabetes as shared
6. facilitated discussion between couple members to identify each person's needs with active listening
7. collaborative implementation intentions
8. EMI text messaging for 7 days following intervention Receives: Behavioral: Communal Coping Intervention |
| Diabetes Education Attention Control | No intervention | These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period
diabetes distress
Measured: baseline, abbreviated for ecological momentary assessment, 6-week followup
change in Self-Care Inventory from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period
self-management
Measured: baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary outcomes (5)
change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome
test kit
Measured: baseline, 6 week followup
change in time in range from baseline to 6 weeks; higher numbers = better outcome; range 0 to 100%; also change over ecological momentary assessment period
data downloaded from continuous glucose monitors
Measured: baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)
change in Center for Epidemiological Depression Scale from baseline to 6 weeks; higher numbers = more depressive symptoms; range = 0 to 30; also change over ecological momentary assessment period
depressive symptoms
Measured: baseline, abbreviated for ecological momentary assessment, 6-week followup
change in Diener's life satisfaction scale from baseline to 6 weeks; higher numbers= more life satisfaction; range = 1-7; also change over ecological momentary assessment period
life satisfaction
Measured: baseline, abbreviated for ecological momentary assessment, 6-week followup
change in Quality of Marriage Index and intimacy subscale from Personal Assessment of Intimacy in Relationships from baseline to 6 weeks; higher numbers = better; range = 1 to 7; also change over ecological momentary assessment period
relationship quality
Measured: baseline, abbreviated for ecological momentary assessment, 6-week followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start2 Aug 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Vicki Helgeson, Carnegie Mellon University
- Investigators
- Vicki Helgeson, Ph.D., Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925556
- Sponsor's protocol ID
- STUDY2022 00000269
- Status last verified
- May 2025
- First submitted
- 22 Jun 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helgeson VS. Communal coping in type 1 diabetes: Randomized trial of a couple-focused intervention. Health Psychol. 2026 May 7. doi: 10.1037/hea0001614. Online ahead of print.
PubMed 42095850
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communal Coping Intervention for Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05925556
- Acronym / sponsor ID
- STUDY2022 00000269
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T1D
Detailed description
We will recruit 66 couples in which one person has type 1 diabetes. Power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. Couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. All couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. The intervention group will receive the communal coping intervention. Couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. After the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. During the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). An in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communal Coping Intervention | Experimental | Behavioral: Communal Coping InterventionThe intervention consists of a single session brief communal coping intervention followed by 7 days of intervention prompts delivered via text message to help couples generalize what they have learned into their daily life. There are 9 components to the intervention: 1. establishment of rapport 2. shared stressor recollection 3. communal coping education 4. application of appraisal to diabetes 5. we-statements to reframe diabetes as shared 6. facilitated discussion between couple members to identify each person's needs with active listening 7. collaborative implementation intentions 8. EMI text messaging for 7 days following intervention |
| Diabetes Education Attention Control | No intervention | –These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of type 1 diabetes for at least one year
Key exclusion criteria (4 listed)
- Non-English speakers
- Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)
- Partner does not consent to participate in study
- Partner has diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communal Coping InterventionThe components of the intervention were described in the experimental arm. | Behavioural | Communal Coping Intervention |
Primary outcome
change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period
Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
diabetes distress
change in Self-Care Inventory from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period
Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
self-management
5 secondary outcomes
change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome
Time frame: baseline, 6 week followup
change in time in range from baseline to 6 weeks; higher numbers = better outcome; range 0 to 100%; also change over ecological momentary assessment period
Time frame: baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)
change in Center for Epidemiological Depression Scale from baseline to 6 weeks; higher numbers = more depressive symptoms; range = 0 to 30; also change over ecological momentary assessment period
Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
change in Diener's life satisfaction scale from baseline to 6 weeks; higher numbers= more life satisfaction; range = 1-7; also change over ecological momentary assessment period
Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
change in Quality of Marriage Index and intimacy subscale from Personal Assessment of Intimacy in Relationships from baseline to 6 weeks; higher numbers = better; range = 1 to 7; also change over ecological momentary assessment period
Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 42095850Helgeson VS. Communal coping in type 1 diabetes: Randomized trial of a couple-focused intervention. Health Psychol. 2026 May 7. doi: 10.1037/hea0001614. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicki Helgeson, Ph.D. principal investigator
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communal Coping Intervention in people with Diabetes Mellitus, Type 1, run by Carnegie Mellon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period (time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.