DepressionBALMSNCT03935529
Behavioural Activation for Low Mood in Multiple Sclerosis
A study testing Behavioural Activation in people with Depression and Secondary-progressive Multiple Sclerosis, run by University of Lincoln at 1 site in United Kingdom.
Trial summary
Title: Behavioural Activation for Low mood in Multiple Sclerosis The study will be sponsored by the University of Lincoln, indemnity will be provided by U M Association Limited. Depression is highly prevalent among people with Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Secondary-progressive Multiple Sclerosis
- What is being tested?
- Behavioural Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2019to 30 Jun 2019
- 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
- Clinical diagnosis of Secondary Progressive Multiple Sclerosis
- Must speak English
- Must have capacity to give consent
- Must have a telephone
- Must have access to the internet
- Must be able to use a computer
- Must score ≥ 8 on the Hospital Anxiety and Depression Scale - depression subscale
Who cannot join
- Receiving psychological therapy for a pre-existing mood problem.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals - Queens Medical Centre
Nottingham
About this study
Title: Behavioural Activation for Low mood in Multiple Sclerosis The study will be sponsored by the University of Lincoln, indemnity will be provided by U M Association Limited.
Depression is highly prevalent among people with Multiple Sclerosis (MS). More specifically, as the disease progresses, people are more likely to develop depression and there is limited evidence of suitable interventions in this group. There are few studies that investigate the most appropriate duration, delivery modality, or individual adaptations for therapy for people with secondary progressive Multiple Sclerosis. This is problematic because continued reduction in physical and cognitive ability, combined with greater incidence of depression, may make accessing and engaging in therapies difficult.
Read more
Behavioural activation is a technique used as a component of psychotherapy. Behavioural activation aims to reduce behaviours that maintain or exacerbate depression by promoting counteracting behaviours, using strategies such as activity monitoring and scheduling.
However, there is no research looking in-depth at the underlying processes. Therefore, this research aims to explore the feasibility and efficacy of behavioural activation by:
- Adapting an existing behavioural activation manual into five sessions, suitable for people with secondary progressive MS.
- Examining if behavioural activation is followed by phases of change that are considered to predict later therapeutic outcome and to determine whether behavioural activation accounts for changes observed.
Up to ten participants from Nottingham University Hospitals will be recruited. Participants will be briefed on the research aims and consent will be obtained before commencing the intervention. The project will follow a multiple baseline single-case experimental design. Participants will complete weekly outcome measures that aim to observe low mood, quality of life, and adherence to behavioural activation and alignment with individual's values. Following five to six contact sessions, participants will take part in a follow-up interview. Participants will then be debriefed.
Read the detailed description
The study aims will be achieved using a single centre, mixed-methods design, over two phases. The first phase will be the adaptation of an existing behavioural activation manual. The aims of the second phase will be achieved using a multiple single-case experimental design and change interview. The multiple single-case experimental design will use an AB design where each participant is their own control.
Participants will be recruited from the Nottingham University Hospitals Trust by the multiple sclerosis (MS) clinical care team, who will provide participants with the study advertisement. The initial approach will be from a member of the patient's usual care team (which may include the investigator), and information about the trial will be on display in the relevant areas. Participants can also self-refer, using information from study-related advertisements placed in the MS clinics, MS Society local branch newsletters and social media. The study aims to recruit up to ten participants. A convenience sampling technique will be used to recruit participants. Following the identification of potential participants, the intervention will be conducted by telephone, internet video-calling software, and face-to-face meetings at the participant's home.
The investigator or their nominee, e.g. from the research team or a member of the participant's usual care team, will inform the participant or their nominated representative (other individual or other body with appropriate jurisdiction), of all aspects pertaining to participation in the study.
Participants will receive a screening and information pack, containing a consent form, participant information sheet, and Hospital Anxiety and Depression Scale. A telephone call from the researcher will provide opportunity for further questions. If the participant does not meet the inclusion criterion, they will be excluded and provided with an information sheet for managing emotions.
It will be explained to the potential participant that entry into the trial is entirely voluntary and that their treatment and care will not be affected by their decision. It will also be explained that they can withdraw at any time, but attempts will be made to avoid this occurrence. In the event of their withdrawal it will be explained that their data collected so far may not be erased in accordance with the University's Research Privacy Notice and information given in the Participant Information Sheet and the investigators will seek consent to use the data in the final analyses where appropriate.
Following the interview, participants will be thanked for their time with a £20 Amazon voucher.
Study as experienced by the participant:
Following recruitment, participants will be sent instructions for installing video communication software (e.g., Skype). The researcher will contact the participant to complete pre-intervention measures and collect demographic and clinical information. Following the contact, participants will complete the baseline measure every-other-day to establish a baseline. Participants will complete measures using Qualtrics (a data management service).
A baseline will be established over two weeks for each participant in which no other contact or procedure will be introduced. The baseline will be considered stable (established) when the participant has recorded no less than three data points on the baseline measure that show no trend toward improvement. If stability has not been demonstrated, the baseline will be extended on a week-by-week basis, for a maximum of two weeks. If a stable baseline has not been established by the fourth week, the participant will exit the study and be provided with information about managing distress and accessing further support.
Intervention (Sessions will be audio recorded):
Treatment planning Participants will receive a single face-to-face session at their home, lasting at least one hour up to a maximum of two hours.
Psychoeducation and behavioural activation Participants will receive a single psychoeducation session, followed by three, fortnightly, behavioural activation sessions. In addition, participants will be offered an optional support session for troubleshooting. Sessions will last up to one hour and contact will be made using internet video software.
Treatment evaluation Participants will receive a review session lasting up to one hour, contact will be made using internet video software.
Post-intervention Participants will be contacted by a fellow Trainee Clinical Psychologist to take part in a 30-minute, one-to-one, audio recorded phone interview.
Follow up (Optional) Two months following the treatment evaluation session participants will complete the follow up measures.
Intervention sessions will be audio recorded and then evaluated by an independent researcher from within the sponsors' institution, such as an MSc student. Fidelity will be investigated using a set framework, to investigate alliance, and content delivery adherence. Should participant decline sessions being audio-recorded, fidelity will be checked via session notes.
Data analysis:
Visual analysis will be used to analyse data collected during the intervention. The analysis identifies any phase-related changes in process and outcome variables. The analysis will provide a visual representation of the covariation between process and outcome measures, to explore whether/how the intervention has a positive impact on mood, fatigue, and quality of life. Additionally, visual analysis will be supplemented with use of reliable and clinically significant change indices, to provide quantitative decision criteria for identifying the statistical robustness and practical importance of any visually-apparent shifts over time. A framework analysis will be used to analysis the responses to the change interview.
- Being tested
- Behavioural Activation
- Medical subject headings
- Depression, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural ActivationBehavioural
Participants will receive five sessions of Behavioural Activation. Behavioural Activation uses strategies such as activity scheduling, mastery and pleasure ratings, and graded task assignments to change a participant's perception of specific situations.
Behavioural Activation is based on the behavioural model of depression (Lewinsohn \& Shaffer, 1971). Specifically, that depression is a result of reduced positive reinforcement, particularly in social relationships. Behavioural Activation aims to reduce depressive symptoms by implementing a schedule of positive reinforcement by altering a participant's behaviour and/or their environment. As, in certain environmental contexts, behaviours that reduce depression will continue to occur through reinforcement and those that increase depression will decrease over time (Roane, Fisher, \& Carr, 2016).
Behavioural Activation has been shown to be an effective intervention for the reduction of depressed mood.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural Acitivation | Experimental | Behavioural Activation. Originally a component of cognitive behavioural therapy, Behavioural Activation is a structured psychotherapeutic approach which aims to (a) increase engagement in activities associated with pleasure or mastery, (b) decrease engagement in activities that maintain depression, and (c) problem solve barriers limiting access to reward or maintain aversive control. Behavioural Activation involves the use of activities to improve life situations or depressed mood. Receives: Behavioral: Behavioural Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression: Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983
Measures changes to anxiety and depression over the last one week. The questionnaire is comprised of two scales (anxiety and depression). Each scale has 7 questions, asking participants to rate between 0-3. The questions for each scale are totalled to produce an overall score between 0-21. Higher scores indicate increased severity of anxiety or depression.
Measured: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Secondary outcomes (3)
Changes to fatigue: Modified Fatigue Impact Scale; Vickrey et al., 1995
Measures changes to fatigue. The modified fatigue impact scale is a modified form of the Fatigue Impact Scale (Fisk et al, 1994b) based on items derived from interviews with Multiple Sclerosis patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Assess the effects of fatigue on quality of life in patients with chronic diseases. Total number of questions 5, asking participants to reflect over the last 4 weeks. The modified fatigue impact scale total score consists of the sum of the raw scores on these 5 items, and thus, can range from 0-20. Higher scores indicate a greater impact of fatigue on a patient's activities.
Measured: Baseline, Week 6, Week 12
Changes to quality of life: Health Status Questionnaire Short form version 2. SF-12v2; Ware, Kosinski, & Keller, 1996
Measures changes to quality of life. Addresses health concepts from the patient's perspective over 8 domains. The survey uses norm-based scoring
Measured: Baseline, Week 6, Week 12
Changes in behaviour associated with depression: The Behavioural Activation for Depression Scale Short Form
Measures changes in behaviours that underlie depression. Track weekly changes in behaviours that underlie depression and that are specifically targeted for change by Behavioural Activation. Asks 9 questions using a 0-6 scale, comprised of 3 subscales. To score, items from all scales other than the Activation scale are reverse-coded and then all items are summed. To score the subscales, no items are reverse-coded. This process allows high scores on the total scale and the subscales to be represented by the scale and subscale names. In other words, for the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment.
Measured: Day 1, day 3, day 5, day 7, day 9, day 11, day 13, day 15, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start4 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nima Moghaddam, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935529
- Sponsor's protocol ID
- 181001
- Acronym
- BALMS
- Status last verified
- May 2019
- First submitted
- 16 Apr 2019
- Last updated
- 11 Jun 2020
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation for Low Mood in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03935529
- Acronym / sponsor ID
- BALMS / 181001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 May 2019 (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.
Title: Behavioural Activation for Low mood in Multiple Sclerosis The study will be sponsored by the University of Lincoln, indemnity will be provided by U M Association Limited.
Depression is highly prevalent among people with Multiple Sclerosis (MS). More specifically, as the disease progresses, people are more likely to develop depression and there is limited evidence of suitable interventions in this group. There are few studies that investigate the most appropriate duration, delivery modality, or individual adaptations for therapy for people with secondary progressive Multiple Sclerosis. This is problematic because continued reduction in physical and cognitive ability, combined with greater incidence of depression, may make accessing and engaging in therapies difficult.
Behavioural activation is a technique used as a component of psychotherapy. Behavioural activation aims to reduce behaviours that maintain or exacerbate depression by promoting counteracting behaviours, using strategies such as activity monitoring and scheduling.
However, there is no research looking in-depth at the underlying processes. Therefore, this research aims to explore the feasibility and efficacy of behavioural activation by:
- Adapting an existing behavioural activation manual into five sessions, suitable for people with secondary progressive MS.
- Examining if behavioural activation is followed by phases of change that are considered to predict later therapeutic outcome and to determine whether behavioural activation accounts for changes observed.
Up to ten participants from Nottingham University Hospitals will be recruited. Participants will be briefed on the research aims and consent will be obtained before commencing the intervention. The project will follow a multiple baseline single-case experimental design. Participants will complete weekly outcome measures that aim to observe low mood, quality of life, and adherence to behavioural activation and alignment with individual's values. Following five to six contact sessions, participants will take part in a follow-up interview. Participants will then be debriefed.
Detailed description
The study aims will be achieved using a single centre, mixed-methods design, over two phases. The first phase will be the adaptation of an existing behavioural activation manual. The aims of the second phase will be achieved using a multiple single-case experimental design and change interview. The multiple single-case experimental design will use an AB design where each participant is their own control.
Participants will be recruited from the Nottingham University Hospitals Trust by the multiple sclerosis (MS) clinical care team, who will provide participants with the study advertisement. The initial approach will be from a member of the patient's usual care team (which may include the investigator), and information about the trial will be on display in the relevant areas. Participants can also self-refer, using information from study-related advertisements placed in the MS clinics, MS Society local branch newsletters and social media. The study aims to recruit up to ten participants. A convenience sampling technique will be used to recruit participants. Following the identification of potential participants, the intervention will be conducted by telephone, internet video-calling software, and face-to-face meetings at the participant's home.
The investigator or their nominee, e.g. from the research team or a member of the participant's usual care team, will inform the participant or their nominated representative (other individual or other body with appropriate jurisdiction), of all aspects pertaining to participation in the study.
Participants will receive a screening and information pack, containing a consent form, participant information sheet, and Hospital Anxiety and Depression Scale. A telephone call from the researcher will provide opportunity for further questions. If the participant does not meet the inclusion criterion, they will be excluded and provided with an information sheet for managing emotions.
It will be explained to the potential participant that entry into the trial is entirely voluntary and that their treatment and care will not be affected by their decision. It will also be explained that they can withdraw at any time, but attempts will be made to avoid this occurrence. In the event of their withdrawal it will be explained that their data collected so far may not be erased in accordance with the University's Research Privacy Notice and information given in the Participant Information Sheet and the investigators will seek consent to use the data in the final analyses where appropriate.
Following the interview, participants will be thanked for their time with a £20 Amazon voucher.
Study as experienced by the participant:
Following recruitment, participants will be sent instructions for installing video communication software (e.g., Skype). The researcher will contact the participant to complete pre-intervention measures and collect demographic and clinical information. Following the contact, participants will complete the baseline measure every-other-day to establish a baseline. Participants will complete measures using Qualtrics (a data management service).
A baseline will be established over two weeks for each participant in which no other contact or procedure will be introduced. The baseline will be considered stable (established) when the participant has recorded no less than three data points on the baseline measure that show no trend toward improvement. If stability has not been demonstrated, the baseline will be extended on a week-by-week basis, for a maximum of two weeks. If a stable baseline has not been established by the fourth week, the participant will exit the study and be provided with information about managing distress and accessing further support.
Intervention (Sessions will be audio recorded):
Treatment planning Participants will receive a single face-to-face session at their home, lasting at least one hour up to a maximum of two hours.
Psychoeducation and behavioural activation Participants will receive a single psychoeducation session, followed by three, fortnightly, behavioural activation sessions. In addition, participants will be offered an optional support session for troubleshooting. Sessions will last up to one hour and contact will be made using internet video software.
Treatment evaluation Participants will receive a review session lasting up to one hour, contact will be made using internet video software.
Post-intervention Participants will be contacted by a fellow Trainee Clinical Psychologist to take part in a 30-minute, one-to-one, audio recorded phone interview.
Follow up (Optional) Two months following the treatment evaluation session participants will complete the follow up measures.
Intervention sessions will be audio recorded and then evaluated by an independent researcher from within the sponsors' institution, such as an MSc student. Fidelity will be investigated using a set framework, to investigate alliance, and content delivery adherence. Should participant decline sessions being audio-recorded, fidelity will be checked via session notes.
Data analysis:
Visual analysis will be used to analyse data collected during the intervention. The analysis identifies any phase-related changes in process and outcome variables. The analysis will provide a visual representation of the covariation between process and outcome measures, to explore whether/how the intervention has a positive impact on mood, fatigue, and quality of life. Additionally, visual analysis will be supplemented with use of reliable and clinically significant change indices, to provide quantitative decision criteria for identifying the statistical robustness and practical importance of any visually-apparent shifts over time. A framework analysis will be used to analysis the responses to the change interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Behavioural Acitivation | Experimental | Behavioral: Behavioural ActivationBehavioural Activation. Originally a component of cognitive behavioural therapy, Behavioural Activation is a structured psychotherapeutic approach which aims to (a) increase engagement in activities associated with pleasure or mastery, (b) decrease engagement in activities that maintain depression, and (c) problem solve barriers limiting access to reward or maintain aversive control. Behavioural Activation involves the use of activities to improve life situations or depressed mood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of Secondary Progressive Multiple Sclerosis
- Must speak English
- Must have capacity to give consent
- Must have a telephone
- Must have access to the internet
Key exclusion criteria (1 listed)
- Receiving psychological therapy for a pre-existing mood problem.
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 |
|---|---|---|
| Behavioural ActivationParticipants will receive five sessions of Behavioural Activation. Behavioural Activation uses strategies such as activity scheduling, mastery and pleasure ratings, and graded task assignments to change a participant's perception of specific situations. Behavioural Activation is based on the behavioural model of depression (Lewinsohn \& Shaffer, 1971). Specifically, that depression is a result of reduced positive reinforcement, particularly in social relationships. Behavioural Activation aims to reduce depressive symptoms by implementing a schedule of positive reinforcement by altering a participant's behaviour and/or their environment. As, in certain environmental contexts, behaviours that reduce depression will continue to occur through reinforcement and those that increase depression will decrease over time (Roane, Fisher, \& Carr, 2016). Behavioural Activation has been shown to be an effective intervention for the reduction of depressed mood. | Behavioural | Behavioural Acitivation |
Primary outcome
Change in depression: Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983
Time frame: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Measures changes to anxiety and depression over the last one week. The questionnaire is comprised of two scales (anxiety and depression). Each scale has 7 questions, asking participants to rate between 0-3. The questions for each scale are totalled to produce an overall score between 0-21. Higher scores indicate increased severity of anxiety or depression.
3 secondary outcomes
Changes to fatigue: Modified Fatigue Impact Scale; Vickrey et al., 1995
Time frame: Baseline, Week 6, Week 12
Changes to quality of life: Health Status Questionnaire Short form version 2. SF-12v2; Ware, Kosinski, & Keller, 1996
Time frame: Baseline, Week 6, Week 12
Changes in behaviour associated with depression: The Behavioural Activation for Depression Scale Short Form
Time frame: Day 1, day 3, day 5, day 7, day 9, day 11, day 13, day 15, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
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 11 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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.
Nima Moghaddam, PhD principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation in people with Depression and Secondary-progressive Multiple Sclerosis, run by University of Lincoln at 1 site in United Kingdom.
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 1 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 11 Jun 2020. 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 Kingdom. 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 depression: Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983 (time frame: Screening, Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12). 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 11 Jun 2020.