Multiple Sclerosis (MS)HLGINCT03177655
Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
A study testing Guided Imagery and Journaling in people with Multiple Sclerosis (MS), run by University of California, San Diego at 1 site in United States.
Trial summary
This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Guided Imagery and Journaling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 1 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Relapsing-Remitting Multiple Sclerosis
- 18-70 years old
- Able to read and write in English
- Able to attend sessions at the UC San Diego School of Medicine
- Age group: adult
- Gender: both
Show all 11Show fewer
- Target enrollment: 20
- Participant exclusion criteria:
- Severe depression (score of 31 or higher on the BDI)
- Very high levels of fatigue (above an average of 6 on the FSS)
- Low levels of mindfulness (below an average score of 2 on the FMI).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.
Read the detailed description
Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced.
Intervention Type: Behavioral
Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Guided Imagery, Journaling
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryOther
Guided Imagery meditation
JournalingOther
Keeping a journal
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | Guided Imagery meditation Receives: Other: Guided Imagery |
| Journaling | Active comparator | Keeping a journal Receives: Other: Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (MS-QOL-54)
Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54)
Measured: Change from baseline at 10 weeks
Secondary outcomes (2)
Mood (BDI-II)
Depressed mood based on the Beck Depression Inventory II (BDI-II)
Measured: Change from baseline at 10 weeks
Fatigue (FSS)
Fatigue levels based on the Fatigue Severity Scale (FSS)
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Mar 2012
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul J. Mills, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177655
- Sponsor's protocol ID
- 121412
- Acronym
- HLGI
- Status last verified
- Jun 2017
- First submitted
- 31 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03177655
- Acronym / sponsor ID
- HLGI / 121412
- Conditions
- Multiple Sclerosis (MS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 6 Jun 2017 (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.
This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.
Detailed description
Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced.
Intervention Type: Behavioral
Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Other: Guided ImageryGuided Imagery meditation |
| Journaling | Active comparator | Other: JournalingKeeping a journal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of Relapsing-Remitting Multiple Sclerosis
- 18-70 years old
- Able to read and write in English
- Able to attend sessions at the UC San Diego School of Medicine
- Severe depression (score of 31 or higher on the BDI)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Guided ImageryGuided Imagery meditation | Other | Guided Imagery |
| JournalingKeeping a journal | Other | Journaling |
Primary outcome
Quality of Life (MS-QOL-54)
Time frame: Change from baseline at 10 weeks
Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54)
2 secondary outcomes
Mood (BDI-II)
Time frame: Change from baseline at 10 weeks
Fatigue (FSS)
Time frame: Change from baseline at 10 weeks
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 6 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Journaling in people with Multiple Sclerosis (MS), run by University of California, San Diego 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 11 inclusion and 0 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 6 Jun 2017. 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?
Quality of Life (MS-QOL-54) (time frame: Change from baseline at 10 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 6 Jun 2017.