Depression, AnxietyNCT07073521
Developing Evidence-Based Cognitive Approaches to Improve Adjustment to Vision Loss
A study testing Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss in people with Depression, Anxiety and Visual Impairment, run by The Chicago Lighthouse at 1 site in United States.
Trial summary
The goal of this study is to develop and pilot test a therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for individuals adjusting to vision loss. The study will begin with focus groups to inform the design of the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Visual Impairment, Adjustment
- What is being tested?
- Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 13 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults who are at least 18 years old
- Experiencing varying degrees of vision loss (e.g. mild, moderate, severe)
- Willingness to participate in the focus group or pilot testing and provide feedback
Who cannot join
- Individuals with severe cognitive impairment affecting participation
- Congenital blindness
- Recent or current participation in another clinical trial study or medical intervention that may interfere with study results
- Documented or self-reported health condition that may interfere with the outcomes of this study.
- Deemed unfit to participate in the study by the site investigator
- Unwilling and/or unable to participate or provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Chicago Lighthouse
Chicago, Illinois, 60608
Senior Research Associate, 312-447-3254, Research@chicagoligthhouse.org
312-447-3234
About this study
The goal of this study is to develop and pilot test a therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for individuals adjusting to vision loss. The study will begin with focus groups to inform the design of the intervention. Participants will complete brief surveys on their background and experiences with vision loss prior to attending a focus group, and some may be invited to a second session to provide additional feedback before preliminary testing begins. In the pilot phase, participants will attend weekly group therapy sessions using the developed intervention and complete assessments before and after the program, including questions about vision status, demographics, and experiences with vision loss.
Read the detailed description
The goal of this study is to develop and pilot test an 8-week cognitive behavioral therapy (CBT) \& mindfulness curriculum tailored for people adjusting to vision loss. Development of the curriculum during the initial phase of this research will include a thorough review of the literature, input from participant groups, and insights from an expert panel. An initial draft of the curriculum will be developed based on the findings from the literature review. 30-40 Participants will have the opportunity to attend up to two focus group sessions to provide feedback and input on content relevance, feasibility, and acceptability of the curriculum. In the pilot testing phase, 15-20 participants will attend eight weekly group therapy sessions held either in-person or virtually using the developed curriculum and will complete assessments before and after the program. These assessments will include questions about your vision, demographics, and experiences with vision loss, as well as collecting baseline and post-intervention measures prior to undergoing the 8-week pilot testing.
- Conditions
- Depression, Anxiety, Visual Impairment, Adjustment, Adjustment Disorder With Anxious Mood, Adjustment Disorder With Depressed Mood, Blindness, Acquired
- Being tested
- Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss
- Keywords
- Visually impaired, Blind, Vision loss, mental health, CBT, Cognitive-behavioral therapy (CBT), mindfulness, adjustment to vision loss, focus group, pilot test, group therapy
- Medical subject headings
- Depression, Anxiety Disorders, Vision Disorders, Blindness, Vision, Low, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision LossBehavioural
The intervention will be an 8-week integrated group therapy curriculum combining cognitive behavioral therapy (CBT) with mindfulness practices designed for individuals adjusting to vision loss.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Testing - Assessing Feasibility and Acceptability | Experimental | Participants will be testing an 8-week therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for people adjusting to vision loss in a group therapy setting and complete assessments before and after completing the program. Receives: Behavioral: Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score
The AVL is a 24-item self-report questionnaire rated on a 5-point Likert scale. Items assess emotional and psychosocial adjustment to vision loss. Scores range from 1 to 5, with higher scores indicating better adaptation. Some items are reverse-scored.
Measured: Assessed at baseline and following the 8-week intervention period
Secondary outcomes (2)
Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score
The Patient Health Questionnaire (PHQ-9) measures average changes in depressive symptoms among participants. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depression.
Measured: Assessed at baseline and following the 8-week intervention period
Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score
The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess the severity of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety. Each item is scored on a 0-3 Likert scale.
Measured: Assessed at baseline and following the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start14 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completion13 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chicago Lighthouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Grant, Ph.D., The Chicago Lighthouse
- Investigators
- Chief Research Officer, Principal investigator, The Chicago Lighthouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073521
- Sponsor's protocol ID
- WSHF - 2025
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidence-Based Cognitive Approaches to Improve Adjustment to Vision Loss
- ClinicalTrials.gov ID
- NCT07073521
- Acronym / sponsor ID
- WSHF - 2025
- Conditions
- Depression, Anxiety, Visual Impairment, Adjustment, Adjustment Disorder With Anxious Mood, Adjustment Disorder With Depressed Mood, Blindness, Acquired
- Keywords
- Visually impaired, Blind, Vision loss, mental health, CBT, Cognitive-behavioral therapy (CBT), mindfulness, adjustment to vision loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Chicago LighthouseUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 13 Jul 2027 (estimated)
- First posted
- 18 Jul 2025 (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.
The goal of this study is to develop and pilot test a therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for individuals adjusting to vision loss. The study will begin with focus groups to inform the design of the intervention. Participants will complete brief surveys on their background and experiences with vision loss prior to attending a focus group, and some may be invited to a second session to provide additional feedback before preliminary testing begins. In the pilot phase, participants will attend weekly group therapy sessions using the developed intervention and complete assessments before and after the program, including questions about vision status, demographics, and experiences with vision loss.
Detailed description
The goal of this study is to develop and pilot test an 8-week cognitive behavioral therapy (CBT) \& mindfulness curriculum tailored for people adjusting to vision loss. Development of the curriculum during the initial phase of this research will include a thorough review of the literature, input from participant groups, and insights from an expert panel. An initial draft of the curriculum will be developed based on the findings from the literature review. 30-40 Participants will have the opportunity to attend up to two focus group sessions to provide feedback and input on content relevance, feasibility, and acceptability of the curriculum. In the pilot testing phase, 15-20 participants will attend eight weekly group therapy sessions held either in-person or virtually using the developed curriculum and will complete assessments before and after the program. These assessments will include questions about your vision, demographics, and experiences with vision loss, as well as collecting baseline and post-intervention measures prior to undergoing the 8-week pilot testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Testing - Assessing Feasibility and Acceptability | Experimental | Behavioral: Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision LossParticipants will be testing an 8-week therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for people adjusting to vision loss in a group therapy setting and complete assessments before and after completing the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults who are at least 18 years old
- Experiencing varying degrees of vision loss (e.g. mild, moderate, severe)
- Willingness to participate in the focus group or pilot testing and provide feedback
Key exclusion criteria (6 listed)
- Individuals with severe cognitive impairment affecting participation
- Congenital blindness
- Recent or current participation in another clinical trial study or medical intervention that may interfere with study results
- Documented or self-reported health condition that may interfere with the outcomes of this study.
- Deemed unfit to participate in the study by the site investigator
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 |
|---|---|---|
| Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision LossThe intervention will be an 8-week integrated group therapy curriculum combining cognitive behavioral therapy (CBT) with mindfulness practices designed for individuals adjusting to vision loss. | Behavioural | Pilot Testing - Assessing Feasibility and Acceptability |
Primary outcome
Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score
Time frame: Assessed at baseline and following the 8-week intervention period
The AVL is a 24-item self-report questionnaire rated on a 5-point Likert scale. Items assess emotional and psychosocial adjustment to vision loss. Scores range from 1 to 5, with higher scores indicating better adaptation. Some items are reverse-scored.
2 secondary outcomes
Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score
Time frame: Assessed at baseline and following the 8-week intervention period
Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score
Time frame: Assessed at baseline and following the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- 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.
Chief Research Officer principal investigator
The Chicago Lighthouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss in people with Depression, Anxiety and Visual Impairment, run by The Chicago Lighthouse 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Research Associate ((312) 447-3254, Research@chicagolighthouse.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score (time frame: Assessed at baseline and following the 8-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.