Multiple SclerosisNCT00621374
Management of Pain in Persons With Multiple Sclerosis
A study testing Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP), Cognitive Behavioral Therapy (CBT) and Self-Hypnosis Training (HYP) in people with Multiple Sclerosis and Pain, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Pain
- What is being tested?
- Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP), Cognitive Behavioral Therapy (CBT) and Self-Hypnosis Training (HYP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2009
- 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
- Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at least 4/10 on 0-10 numeric rating scale
- Pain is either worse or started since the onset of other MS symptoms.
- Pain of at least six months duration.
- Reads, speaks and understands English.
- Definitive diagnosis of multiple sclerosis (MS)
- At least 18 years of age
- Recruited from a recruitment source approved by the IRB
Who cannot join
- Severe cognitive impairment resulting in the inability to verbally comprehend, learn, and recall new auditory verbal information, as reflected by a TICS score of 20 or less.
- Currently participating in counseling and/or psychotherapy more than once a week.
- Currently taking anti-psychotic medications
- Has been hospitalized for psychiatric reasons in the past six months
- Experiencing current active suicidal ideation.
- Has received treatment or participated in a clinical trial that involved significant elements of either CBT or hypnosis within the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis
The purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.
Read the detailed description
This study examined the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We conducted a time series design in which MS subjects received all four treatment conditions in two orders (randomly assigned): (1) Control (education intervention-CONT),Self-Hypnosis Training (HYP), Cognitive Behavioral Therapy (CBT), HYP-CBT(a combination of HYP and CBT) and (2) CONT, CBT, HYP, HYP-CBT. Subjects attended 16 60-minute treatment sessions conducted by one of the study's psychologists either at the UW,HMC or in the subject's home. Each subject received four treatment sessions of each treatment module listed above. Primary outcome measures were collected via the telephone and mail by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends. Secondary outcome measures were collected at the same assessment points via pencil and paper interviews completed by subjects.
- Conditions
- Multiple Sclerosis, Pain
- Being tested
- Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP), Cognitive Behavioral Therapy (CBT), Self-Hypnosis Training (HYP), Education Control (CONT)
- Keywords
- Pain Management, Cognitive Behavior Therapy, Hypnosis
- Medical subject headings
- Multiple Sclerosis, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP)Behavioural
There is also the possibility that the two treatments together may be even more helpful than either one alone. Because some of the patients in this study will get both CBT and self-hypnosis, we will be able to determine if each one facilitates the efficacy of the other. If the patients treated in this study report benefits, as we expect they will, then this will encourage us to design and complete a larger study to better understand how patients with MS would benefit from these treatments.
Cognitive Behavioral Therapy (CBT)Behavioural
One treatment module is we will study is called "cognitive restructuring" or "cognitive-behavior therapy" (CBT). In this treatment, people learn to identify negative thoughts that make them feel bad or anxious. Such negative thoughts lead to feelings of frustration and anxiety, and can even increase the experience of pain, because they cause a person to focus more on pain. With CBT, people learn to identify and stop these thoughts, and then replace them with more reassuring ones. When they do this, they feel more relaxed and focus less on their pain. As a result, they often say that they feel much better and are less aware of pain.
Self-Hypnosis Training (HYP)Behavioural
Self-hypnosis (HYP) is another strategy that people can learn to manage pain. With this treatment, people learn to enter a state of focused attention, and then change how they experience pain. Although we do not yet know how hypnosis works, research has repeatedly shown that the effects are real; when people report decreases in pain with hypnosis, scans and images of the brain's activity show decreases in the parts of the brain that process pain information. With hypnosis, people are not just pretending to feel less pain, they actually do feel less pain.
Education Control (CONT)Behavioural
The CONT condition for this study will include lectures that are interactive and are compelling and informative enough to be both (1) credible as an attentional control condition and (2) perceived as helpful to subjects. The CONT condition will not, however, include instructions in making specific cognitive or behavioral changes related to pain management. Thus, it could control for non-specific factors related to behavioral treatment, but will not impact the primary outcome measure (pain).
| Study group | Role | What they receive |
|---|---|---|
| Random Order 1 | Experimental | Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP Receives: Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP); Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Self-Hypnosis Training (HYP); Behavioral: Education Control (CONT) |
| Random Order 2 | Experimental | Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP Receives: Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP); Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Self-Hypnosis Training (HYP); Behavioral: Education Control (CONT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
Measured: Before treatment, after each treatment module, and 1-month after the final treatment module.
Secondary outcomes (9)
Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Depression- (CMDI; Nyenhuis et al., 1998)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Catastrophizing cognitions- (PCS; Sullivan et al. 1995)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Adaptive cognitions (CPAQ; McCracken et al., 2004)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Impact of Fatigue (FIS; Fisk et al. 1993)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Fatigue Severity (FSS; Krupp et al., 1989)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Health Status (SF-36; Ware et al., 1992)
Measured: before treatment, after each treatment module, one month after 4th treatment modules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2009
- Study completionJun 2009
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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Mark Jensen, University of Washington
- Investigators
- Mark P Jensen, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621374
- Sponsor's protocol ID
- 32022-A
- Other IDs
- NMSS Award# PP1465
- Status last verified
- Jan 2013
- First submitted
- 12 Feb 2008
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen MP, Ehde DM, Gertz KJ, Stoelb BL, Dillworth TM, Hirsh AT, Molton IR, Kraft GH. Effects of self-hypnosis training and cognitive restructuring on daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2011 Jan;59(1):45-63. doi: 10.1080/00207144.2011.522892.
PubMed 21104484
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00621374
- Acronym / sponsor ID
- 32022-A
- Conditions
- Multiple Sclerosis, Pain
- Keywords
- Pain Management, Cognitive Behavior Therapy, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Feb 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- 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 purpose of this study is to see if treatments that include components of self-hypnosis training and cognitive behavioral therapy (CBT) can help decrease pain in people with MS.
Detailed description
This study examined the benefits of two treatments, individually and together, for helping individuals with MS manage their pain. We conducted a time series design in which MS subjects received all four treatment conditions in two orders (randomly assigned): (1) Control (education intervention-CONT),Self-Hypnosis Training (HYP), Cognitive Behavioral Therapy (CBT), HYP-CBT(a combination of HYP and CBT) and (2) CONT, CBT, HYP, HYP-CBT. Subjects attended 16 60-minute treatment sessions conducted by one of the study's psychologists either at the UW,HMC or in the subject's home. Each subject received four treatment sessions of each treatment module listed above. Primary outcome measures were collected via the telephone and mail by research personnel blind to the treatment condition before treatment, immediately after treatment ends and one month after treatment ends. Secondary outcome measures were collected at the same assessment points via pencil and paper interviews completed by subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Random Order 1 | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP), Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Self-Hypnosis Training (HYP), Behavioral: Education Control (CONT)Randomization Order 1= 1)CONT, 2)CBT, 3)HYP, 4) CBT-HYP |
| Random Order 2 | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP), Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Self-Hypnosis Training (HYP), Behavioral: Education Control (CONT)Randomization order 2= 1)CONT, 2)HYP, 3)CBT, 4) CBT-HYP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at least 4/10 on 0-10 numeric rating scale
- Pain is either worse or started since the onset of other MS symptoms.
- Pain of at least six months duration.
- Reads, speaks and understands English.
- Definitive diagnosis of multiple sclerosis (MS)
Key exclusion criteria (6 listed)
- Severe cognitive impairment resulting in the inability to verbally comprehend, learn, and recall new auditory verbal information, as reflected by a TICS score of 20 or less.
- Currently participating in counseling and/or psychotherapy more than once a week.
- Currently taking anti-psychotic medications
- Has been hospitalized for psychiatric reasons in the past six months
- Experiencing current active suicidal ideation.
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 Behavioral Therapy (CBT) +Hypnosis (HYP)There is also the possibility that the two treatments together may be even more helpful than either one alone. Because some of the patients in this study will get both CBT and self-hypnosis, we will be able to determine if each one facilitates the efficacy of the other. If the patients treated in this study report benefits, as we expect they will, then this will encourage us to design and complete a larger study to better understand how patients with MS would benefit from these treatments. | Behavioural | Random Order 1, Random Order 2 |
| Cognitive Behavioral Therapy (CBT)One treatment module is we will study is called "cognitive restructuring" or "cognitive-behavior therapy" (CBT). In this treatment, people learn to identify negative thoughts that make them feel bad or anxious. Such negative thoughts lead to feelings of frustration and anxiety, and can even increase the experience of pain, because they cause a person to focus more on pain. With CBT, people learn to identify and stop these thoughts, and then replace them with more reassuring ones. When they do this, they feel more relaxed and focus less on their pain. As a result, they often say that they feel much better and are less aware of pain. | Behavioural | Random Order 1, Random Order 2 |
| Self-Hypnosis Training (HYP)Self-hypnosis (HYP) is another strategy that people can learn to manage pain. With this treatment, people learn to enter a state of focused attention, and then change how they experience pain. Although we do not yet know how hypnosis works, research has repeatedly shown that the effects are real; when people report decreases in pain with hypnosis, scans and images of the brain's activity show decreases in the parts of the brain that process pain information. With hypnosis, people are not just pretending to feel less pain, they actually do feel less pain. | Behavioural | Random Order 1, Random Order 2 |
| Education Control (CONT)The CONT condition for this study will include lectures that are interactive and are compelling and informative enough to be both (1) credible as an attentional control condition and (2) perceived as helpful to subjects. The CONT condition will not, however, include instructions in making specific cognitive or behavioral changes related to pain management. Thus, it could control for non-specific factors related to behavioral treatment, but will not impact the primary outcome measure (pain). | Behavioural | Random Order 1, Random Order 2 |
Primary outcome
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.
Time frame: Before treatment, after each treatment module, and 1-month after the final treatment module.
9 secondary outcomes
Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Depression- (CMDI; Nyenhuis et al., 1998)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Catastrophizing cognitions- (PCS; Sullivan et al. 1995)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Adaptive cognitions (CPAQ; McCracken et al., 2004)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Impact of Fatigue (FIS; Fisk et al. 1993)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Fatigue Severity (FSS; Krupp et al., 1989)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
Health Status (SF-36; Ware et al., 1992)
Time frame: before treatment, after each treatment module, one month after 4th treatment modules
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 16 Jan 2013.
- Results publication: PubMed 21104484Jensen MP, Ehde DM, Gertz KJ, Stoelb BL, Dillworth TM, Hirsh AT, Molton IR, Kraft GH. Effects of self-hypnosis training and cognitive restructuring on daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. Int J Clin Exp Hypn. 2011 Jan;59(1):45-63. doi: 10.1080/00207144.2011.522892.
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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.
Mark P Jensen, Ph.D. principal investigator
University of Washington
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 Behavioral Therapy (CBT) +Hypnosis (HYP), Cognitive Behavioral Therapy (CBT) and Self-Hypnosis Training (HYP) in people with Multiple Sclerosis and Pain, run by University of Washington 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 7 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: finished, as of the sponsor's last update on 16 Jan 2013. 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?
A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff. (time frame: Before treatment, after each treatment module, and 1-month after the final treatment module.). 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 NCT00621374, 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 16 Jan 2013.