Parkinson Disease (PD)LIFECOG-PDNCT07813156
Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program (LIFECOG-PD)
A study testing cognitive rehabilitation program in people with Parkinson Disease (PD), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- cognitive rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 30 Sep 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
- • Men or women ≥18 years old, diagnosed with idiopathic Parkinson's disease according to the official diagnostic criteria defined by the Movement Disorder Society (MDS) ;
- Without cognitive impairment based on neuropsychological evaluation or meeting level 2 Mild Cognitive Impairment (MCI) criteria defined by the MDS, and presenting an early subjective cognitive complaint defined by a score between 1 and 8 on the Subjective Cognitive Complaints Questionnaire for Parkinson's Disease (SCCQ-PD)
- Non-demented according to MDS criteria
- Ability to understand the protocol;
- Ability to provide free and informed consent;
- Patients covered by a social insurance system.
Who cannot join
- • Any associated neurological disorder or active psychiatric pathology, including severe depressive episode or active psychotic episode. Participants with a Beck Depression Inventory (BDI-II) score above 21 will be excluded from the study and referred to an appropriate healthcare professional for further evaluation and follow-up as needed.
- Patients meeting the criteria for Parkinson's disease dementia
- Any clinical sign suggesting atypical parkinsonian syndrome (ocular motor disorder, cognitive impairment, apraxia, early falls).
- Pregnant or breastfeeding women
- Participants under legal protection measures such as judicial protection, deprivation of liberty, curatorship, or guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Clermont-Fd
Clermont-Ferrand, 63000
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
About this study
Official title: Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program
Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Cognitive rehabilitation is a structured program designed to help improve or compensate for patients' cognitive abilities by providing an approach tailored to each patient's individual needs and goals. Neuropsychologists from French Parkinson's Disease expert centers have developed a new cognitive rehabilitation program called LifeCOG-PD, for PD patients with a subjective cognitive complaint or a mild cognitive impairment (MCI), delivered at the hospital in seven 90-minute sessions conducted in groups of 3-4 participants. This program, combining psychoeducation, practical strategies, and personalized goal setting, aims to maintain patients' daily autonomy, enhance quality of life, and delay the cognitive impact of the disease.
By evaluating feasibility, acceptability and functional outcomes, this study will contribute critical data to inform future PD management guidelines to help support autonomy and cognitive resilience in PD.
Read the detailed description
This pilot interventional therapeutic study will aim at evaluating the feasibility and acceptability of a new cognitive rehabilitation program designed to preserve autonomy and social roles among early PD MCI patients or isolated subjective cognitive complaint.
24 patients will be enrolled in this study in 5 french centers : Clermont-Ferrand, Bordeaux, Créteil, Nancy and Strasbourg.
The inclusion period is 12 months, and each patient's participation duration is a maximum of 13 months. This study will include 10 visits at the hospital :
- inclusion visit (during the month preceding the start of the program)
- 7 sessions of the program (W0, W2, W4, W6, W8, W10, W112)
- a visit at 24 weeks (3 months after the end of the program)
- a visit at 48 weeks (9 months after the end of the program)
Patients will receive 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals. The neuropsychologist will be blinded from the neuropsychological assessment and the functional goals.
If the patient has a caregiver (spouse or other relative), the investigator may propose them to participate in the study. Their participation will consist of completing a satisfaction questionnaire assessing the perceived benefits of the program for the patient at 3 and 9 months post-program. If they agree, the investigator will obtain their agreement to the collection and use of their data within the framework of this research.
- Conditions
- Parkinson Disease (PD)
- Being tested
- cognitive rehabilitation program
- Keywords
- parkinson' s disease, cognitive rehabilitation program, subjective cognitive complaint or a mild cognitive impairment, functional autonomy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive rehabilitation programOther
Patients will receive the program in 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals.
| Study group | Role | What they receive |
|---|---|---|
| cognitive rehabilitation program | Experimental | Patients will receive the new cognitive rehabilitation program. Receives: Other: cognitive rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients completing the 7 sessions of the program
Measured: at the end of the program at 12 weeks
Secondary outcomes (52)
Proportion of ineligible participants after screening and inclusion
Measured: at inclusion visit
Number of participants who withdrew until the end of the program (Dropout rates).
Measured: at the end of the program at 12 weeks
Perceived level of interest with a satisfaction questionnaire (The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Measured: At the end the program at 12 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using qualitative questionnaire
Measured: et the end of the program at 12 weeks
Perceived benefits of the program as reported by the participant at 3 months post treatment using qualitative questionnaire
Measured: at 24 weeks
Perceived benefits of the program as reported by the participant at 9 months post treatment using qualitative questionnaire
Measured: at 48 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 3 months post treatment using qualitative questionnaire
Measured: at 24 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 9 months post treatment using qualitative questionnaire
Measured: at 48 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Measured: at 24 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Measured: at 48 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Measured: at inclusion visit
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Measured: at 24 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Measured: at 48 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Measured: at inclusion visit
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Measured: at 24 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Measured: at 48 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Measured: at inclusion visit
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Measured: at 24 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Measured: at 48 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Measured: at inclusion visit
Self-Esteem using the Rosenberg Self-Esteem Scale
Measured: at 24 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Measured: at 48 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Measured: at inclusion visit
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Measured: at 24 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Measured: at 48 weeks
Global cognitive assessment using the Montreal Cognitive Assessment
Measured: at inclusion visit
Global cognitive assessment using the Montreal Cognitive Assessment
Measured: at 48 weeks
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Measured: at inclusion visit
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Measured: at 48 weeks
Episodic memory using the Brief Visuospatial Memory Test-R
Measured: at inclusion visit
Episodic memory using brief Visuospatial Memory Test-R
Measured: at 48 weeks
Attention using Digit Symbol Modalities test
Measured: at inclusion visit
Attention using Digit Symbol Modalities test
Measured: at 48 weeks
Attention using the Digit Span (Forward and Backward)
Measured: at inclusion visit
Attention using digit Span (Forward and Backward)
Measured: at 48 weeks
Executive functions using oral Letter-Number Sequencing task
Measured: at inclusion visit
Executive functions using oral Letter-Number Sequencing task
Measured: at 48 weeks
Executive functions using stroop Color and Word Test D-KEFS
Measured: at inclusion visit
Executive functions using stroop Color and Word Test D-KEFS
Measured: at 48 weeks
Visuo spatial treatment using the Benton Judgment of Line Orientation Test
Measured: at inclusion visit
Visuo spatial treatment using the Benton Judgment of Line Orientation Test
Measured: at 48 weeks
Visuo spatial treatment using the clock drawing test
Measured: at inclusion visit
Visuo spatial treatment using the clock drawing test
Measured: at 48 weeks
Language using the Boston Naming Test (French short form)
Measured: at inclusion visit
Language using the Boston Naming Test (French short form)
Measured: at 48 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the first session of the program
Measured: at week 0
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 2 of the program
Measured: at 2 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 3 of the program
Measured: at 4 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 4 of the program
Measured: at 6 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 5 of the program
Measured: at 8 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 6 of the program
Measured: at 10 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 7 of the program
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine VIDAL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813156
- Sponsor's protocol ID
- RBHP 2026 VIDAL
- Other IDs
- 2026-A01122-49
- Acronym
- LIFECOG-PD
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program
- ClinicalTrials.gov ID
- NCT07813156
- Acronym / sponsor ID
- LIFECOG-PD / RBHP 2026 VIDAL
- Conditions
- Parkinson Disease (PD)
- Keywords
- parkinson' s disease, cognitive rehabilitation program, subjective cognitive complaint or a mild cognitive impairment, functional autonomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Cognitive rehabilitation is a structured program designed to help improve or compensate for patients' cognitive abilities by providing an approach tailored to each patient's individual needs and goals. Neuropsychologists from French Parkinson's Disease expert centers have developed a new cognitive rehabilitation program called LifeCOG-PD, for PD patients with a subjective cognitive complaint or a mild cognitive impairment (MCI), delivered at the hospital in seven 90-minute sessions conducted in groups of 3-4 participants. This program, combining psychoeducation, practical strategies, and personalized goal setting, aims to maintain patients' daily autonomy, enhance quality of life, and delay the cognitive impact of the disease.
By evaluating feasibility, acceptability and functional outcomes, this study will contribute critical data to inform future PD management guidelines to help support autonomy and cognitive resilience in PD.
Detailed description
This pilot interventional therapeutic study will aim at evaluating the feasibility and acceptability of a new cognitive rehabilitation program designed to preserve autonomy and social roles among early PD MCI patients or isolated subjective cognitive complaint.
24 patients will be enrolled in this study in 5 french centers : Clermont-Ferrand, Bordeaux, Créteil, Nancy and Strasbourg.
The inclusion period is 12 months, and each patient's participation duration is a maximum of 13 months. This study will include 10 visits at the hospital :
- inclusion visit (during the month preceding the start of the program)
- 7 sessions of the program (W0, W2, W4, W6, W8, W10, W112)
- a visit at 24 weeks (3 months after the end of the program)
- a visit at 48 weeks (9 months after the end of the program)
Patients will receive 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals. The neuropsychologist will be blinded from the neuropsychological assessment and the functional goals.
If the patient has a caregiver (spouse or other relative), the investigator may propose them to participate in the study. Their participation will consist of completing a satisfaction questionnaire assessing the perceived benefits of the program for the patient at 3 and 9 months post-program. If they agree, the investigator will obtain their agreement to the collection and use of their data within the framework of this research.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive rehabilitation program | Experimental | Other: cognitive rehabilitation programPatients will receive the new cognitive rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Men or women ≥18 years old, diagnosed with idiopathic Parkinson's disease according to the official diagnostic criteria defined by the Movement Disorder Society (MDS) ;
Key exclusion criteria (5 listed)
- • Any associated neurological disorder or active psychiatric pathology, including severe depressive episode or active psychotic episode. Participants with a Beck Depression Inventory (BDI-II) score above 21 will be excluded from the study and referred to an appropriate healthcare professional for further evaluation and follow-up as needed.
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 |
|---|---|---|
| cognitive rehabilitation programPatients will receive the program in 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals. | Other | cognitive rehabilitation program |
Primary outcome
Proportion of patients completing the 7 sessions of the program
Time frame: at the end of the program at 12 weeks
52 secondary outcomes
Proportion of ineligible participants after screening and inclusion
Time frame: at inclusion visit
Number of participants who withdrew until the end of the program (Dropout rates).
Time frame: at the end of the program at 12 weeks
Perceived level of interest with a satisfaction questionnaire (The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Time frame: At the end the program at 12 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using qualitative questionnaire
Time frame: et the end of the program at 12 weeks
Perceived benefits of the program as reported by the participant at 3 months post treatment using qualitative questionnaire
Time frame: at 24 weeks
Perceived benefits of the program as reported by the participant at 9 months post treatment using qualitative questionnaire
Time frame: at 48 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 3 months post treatment using qualitative questionnaire
Time frame: at 24 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 9 months post treatment using qualitative questionnaire
Time frame: at 48 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Time frame: at 24 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Time frame: at 48 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at inclusion visit
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at 24 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at 48 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at inclusion visit
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at 24 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at 48 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at inclusion visit
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at 24 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at 48 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at inclusion visit
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at 24 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at 48 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at inclusion visit
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at 24 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at 48 weeks
Global cognitive assessment using the Montreal Cognitive Assessment
Time frame: at inclusion visit
Global cognitive assessment using the Montreal Cognitive Assessment
Time frame: at 48 weeks
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Time frame: at inclusion visit
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Time frame: at 48 weeks
Episodic memory using the Brief Visuospatial Memory Test-R
Time frame: at inclusion visit
Episodic memory using brief Visuospatial Memory Test-R
Time frame: at 48 weeks
Attention using Digit Symbol Modalities test
Time frame: at inclusion visit
Attention using Digit Symbol Modalities test
Time frame: at 48 weeks
Attention using the Digit Span (Forward and Backward)
Time frame: at inclusion visit
Attention using digit Span (Forward and Backward)
Time frame: at 48 weeks
Executive functions using oral Letter-Number Sequencing task
Time frame: at inclusion visit
Executive functions using oral Letter-Number Sequencing task
Time frame: at 48 weeks
Executive functions using stroop Color and Word Test D-KEFS
Time frame: at inclusion visit
Executive functions using stroop Color and Word Test D-KEFS
Time frame: at 48 weeks
Visuo spatial treatment using the Benton Judgment of Line Orientation Test
Time frame: at inclusion visit
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 10 Sep 2026.
- 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.
Tiphaine VIDAL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive rehabilitation program in people with Parkinson Disease (PD), run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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 France. 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 Lise LACLAUTRE (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients completing the 7 sessions of the program (time frame: at the end of the program at 12 weeks). 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 10 Sep 2026.