Bipolar DisorderNCT03750305
Evaluating the Effectiveness of Imagery Focussed Therapy
A study testing imagery-focused Cognitive Therapy and TAU in people with Bipolar Disorder, run by Maastricht University at 1 site in Netherlands.
Trial summary
This study explores the effectiveness of a brief Imagery-focussed Cognitive Therapy (imCT) compared to psychoeducation, regarded as treatment as usual for this patient population, in patients suffering from BD receiving mood stabilising medication. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- imagery-focused Cognitive Therapy and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2018to 30 Dec 2020
- 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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-68
- Sufficient Dutch language ability to permit the assessment to be completed.
- Diagnosis of DB (I or II or NOS) according to DSM-5 (clinicians assessment).
- Willing to complete daily and weekly monitoring throughout the duration of the study.
- Successful completion of the daily monitoring in the 4 weeks active run-in phase.
- Willing to be randomised to either imCT or psychoeducation/TAU condition
- Can commit to attending 12 consecutive weekly sessions imCT or psychoeducation/TAU.
Who cannot join
- Learning difficulties, organic brain disease or severe neurological impairment.
- Current severe substance or alcohol misuse (clinicians assessment).
- Current manic episode as diagnosed by DSM-5
- Current active psychotic symptoms
- Presence of active suicidal risk as indicated by a score of 2 or more on item 12 (i.e. frequent thought and/or plans to end their life) of the QIDS (Rush et al., 2003) confirmed by convergent clinical opinion.
- Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for BD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Imagery Focussed Therapy in Patients Suffering From Bipolar Disorder: an Exploratory Trial
This study explores the effectiveness of a brief Imagery-focussed Cognitive Therapy (imCT) compared to psychoeducation, regarded as treatment as usual for this patient population, in patients suffering from BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU.
Read the detailed description
Bipolar disorder (BD) is a severe mental health illness affecting 1.9% to 2.4% of the population and is associated with high inter episode distress, ongoing mood swings (mood variability), high suicide risks and high co-morbidity (especially anxiety). 50% of patients do not recover within one year, and only 25% of patients achieve full recovery of function, despite receiving the recommended lead intervention consisting of pharmacotherapy (mood stabilisers such as lithium). Added psychoeducation and cognitive behavioural interventions (CBT) have only modest effects. Overall there is consensus for the need to update CBT and increase its effectiveness, aimed at not only managing symptoms but also targeting perpetuating or precipitating factors influencing symptoms, especially mood variability.
Recent studies suggest that patients with BD experience more vivid, compelling and upsetting mental images compared to patients suffering from unipolar depression and healthy controls and that this may contribute to or even maintain their clinical difficulties. That is, imagery in experimental research has proven to have a stronger effect on mood changes than verbal cognitions. The amplified imagery vividness of patients suffering from BD might therefore precipitate or perpetuate their mood variability. In many other mental health problems imagery interventions as a stand-alone intervention, or added to regular CBT, are offered with the aim to decrease imagery vividness or modify/update appraisals of imagery. In BD patients such interventions, therefore, might also target important precipitating or perpetuating factors influencing their mood problems.
This study aims to assess the effectiveness of a brief Imagery-focussed Cognitive Therapy (imCT) compared to psychoeducation, regarded as treatment as usual for this patient population, in patients suffering from BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU. The investigators hypothesise that (1a) mood variability (primary outcome variable) and (1b) symptoms of depression, mania and anxiety (secondary outcome variables) show stronger decreases in BD patients receiving imCT than in patients receiving psychoeducation/TAU. Moreover, (2) in the imCT group this effect is expected to be mediated by changes in imagery which is targeted during this intervention (target imagery). The investigators also hypothese that (3) imagery frequency and compellingness and vividness of imagery reduce more in the imCT group than in the group receiving psychoeducation/TAU. The primary outcome variable, mood variability, is calculated using daily mood measurements, during a 4-week baseline, during the invention and after the end of intervention until follow up at 16 weeks, in both imCT and psychoeducation/TAU. Most secondary outcome variables are assessed using weekly online questionnaires, pre-and post intervention and at 8 and 16 weeks follow-up, anxiety is calculated both weekly online and using daily measurements (see below).
- Conditions
- Bipolar Disorder
- Being tested
- imagery-focused Cognitive Therapy, TAU
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagery-focused Cognitive TherapyOther
Also called ImCT
In depth identification phase: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus.
Imagery interventions: The imagery intervention consists of metacognitive imagery rescripting or promoting positive imagery or competing tasks (or a combination of these).
Consolidation: Consist of fine tuning the strategies, relapse prevention using a video diary.
TAUOther
Also called Psychoeducation
Psycho-education is offered in groups, using the format described by Honig (Postma, Honig, \& van Gent, 2008).
| Study group | Role | What they receive |
|---|---|---|
| psychoeducation/TAU | Active comparator | TAU consists of psycho-education for a period of 12 weeks, consisting of 6 2-hour sessions. Psycho-education is offered in groups, Receives: Other: TAU |
| imCT intervention | Experimental | For a period of 12 weeks, 12 1-hour sessions of imagery-focused Cognitive Therapy delivered weekly by a trained therapists, divided in an in depth identification (4 sessions) of images followed by imagery interventions, (6 sessions) and a consolidation phase (2 sessions). Receives: Other: imagery-focused Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Mood variability to follow up at 16 weeks after end of intervention
Mood variability is measured using the Affect Lability Score Short Version (ALS-18; Oliver \& Simons, 2004). The ALS-18 is a self-report scale measuring lability in affect and consists of 18 items. Ratings are made on a 4-point scale with a maximum score of 72. Scores range from A= very characteristic of me (4 points), to D= very uncharacteristic of me (1 point).
Measured: The ALS-18 is administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.
Secondary outcomes (7)
Change from baseline Level of depression to follow up at to follow up at 16 weeks
- Level of depression, using the Quick Inventory of Depressive Symptoms (QIDS-SR) (Rush et al., 2003). The QIDS-SR is a 16-item self-report rating scale in which the nine DSM 5 symptoms of major depression are incorporated. Answers are rated on a four-point Likert scale (0-3).
Measured: measured weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU).
Change from baseline level of mania to follow up at 16 weeks
- Level of mania, using the Altman Self-Rating Mania Scale (ASRM-NL) (Altman, Hedekker, \& Peterson, 1997). The ASRM-NL is a 5 item self-report instrument to measure severity of mania symptoms. Answers are rated on a 5-point Likert scale, where higher scores indicate higher levels of mania. Total score ranges from 0 to 20, with a cut off score of 5 or more indicating relapse into mania.
Measured: measured weekly throughout the duration of the study in both groups ( 32 weeks imCT and 26 weekspsychoeducation/TAU).
Change from baseline level of anxiety to follow up at 16 weeks
- Level of anxiety, using the Beck Anxiety Inventory (BAI) (Osman, Barrios, Aukes, Osman, \& Markway, 1993). The BAI is a 21-item self-report questionnaire used for measuring the severity of anxiety. Answers are rated on a 4-point Likert scale (0-3). Total scores range from o to 63, where scores of 22 or more indicate moderate anxiety, 36 or more concerning levels of anxiety.
Measured: measured both daily and weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU)
Change from baseline level of hopelessness to follow up at 16 weeks follow up
participants rate their hopelessness using the Beck Hopelessness Scale (Beck, Brown, \& Steer, 1997), The BHS is a 20 item self-report scale measuring three aspects of hopelessness: feelings about the future, motivation and expectations. The BHS demonstrates good internal consistency (alpha = .93) and has high reliability in psychiatric samples (Beck et al., 1997)
Measured: measured at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention after 6 weeks in the psychoeduc condition and 12 weeks in the ImCT condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
Change from baseline level of general functioning and coping to follow up at 16 weeks
Participants rate their level of functioning using the Longitudinal Interval Follow up Evaluation - Range of Impaired Functioning Tool (Leon, et al., 1999). This is a brief scale for people suffering from affective disorders, measuring four different functional areas (employment, interpersonal relations, satisfaction and recreation) on a 5 point Likert scale (low rating imply higher functioning).
Measured: Participants rate their level of functioning at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention12 weeks in the ImCT condition and 6 weeks in the psychoeducation condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
Change from baseline level of mood variability to follow up at 16 weeks
Mood variability, using daily measurements of both mania and depression with the National Institute of Mental Health Life Chart Methodology (NIMH-LCM) Prospective Self-Rating (Denicoff et al., 2000; Leverich and Post, 1998). Participants rate their mood (both mania and depression) on a 11-point likert scale, ranging from -4 (severe depression, admission required due to severe dysfunction) to 0 (stable mood) to +4 (severe mania, admission required due to severe dysfunction).
Measured: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
Change from baseline level of anxiety to follow up at 16 weeks
Anxiety is measured on a VAS scale indicating no anxiety (1) to severe anxiety (4).
Measured: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Oct 2018
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
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 Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between groups, comparing Imagery-Focussed therapy with psychoeducation/TAU/within group, comparing baseline phase with treatment phase.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin van den Berg, Maastricht University
- Investigators
- karin van den Berg, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750305
- Sponsor's protocol ID
- IMCT in BD
- Status last verified
- Aug 2021
- First submitted
- 27 Feb 2018
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Berg KC, Hendrickson AT, Hales SA, Voncken M, Keijsers GPJ. Comparing the effectiveness of imagery focussed cognitive therapy to group psychoeducation for patients with bipolar disorder: A randomised trial. J Affect Disord. 2023 Jan 1;320:691-700. doi: 10.1016/j.jad.2022.09.160. Epub 2022 Oct 5.
PubMed 36206888
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Imagery Focussed Therapy in Patients Suffering From Bipolar Disorder: an Exploratory Trial
- ClinicalTrials.gov ID
- NCT03750305
- Acronym / sponsor ID
- IMCT in BD
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 23 Nov 2018 (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 study explores the effectiveness of a brief Imagery-focussed Cognitive Therapy (imCT) compared to psychoeducation, regarded as treatment as usual for this patient population, in patients suffering from BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU.
Detailed description
Bipolar disorder (BD) is a severe mental health illness affecting 1.9% to 2.4% of the population and is associated with high inter episode distress, ongoing mood swings (mood variability), high suicide risks and high co-morbidity (especially anxiety). 50% of patients do not recover within one year, and only 25% of patients achieve full recovery of function, despite receiving the recommended lead intervention consisting of pharmacotherapy (mood stabilisers such as lithium). Added psychoeducation and cognitive behavioural interventions (CBT) have only modest effects. Overall there is consensus for the need to update CBT and increase its effectiveness, aimed at not only managing symptoms but also targeting perpetuating or precipitating factors influencing symptoms, especially mood variability.
Recent studies suggest that patients with BD experience more vivid, compelling and upsetting mental images compared to patients suffering from unipolar depression and healthy controls and that this may contribute to or even maintain their clinical difficulties. That is, imagery in experimental research has proven to have a stronger effect on mood changes than verbal cognitions. The amplified imagery vividness of patients suffering from BD might therefore precipitate or perpetuate their mood variability. In many other mental health problems imagery interventions as a stand-alone intervention, or added to regular CBT, are offered with the aim to decrease imagery vividness or modify/update appraisals of imagery. In BD patients such interventions, therefore, might also target important precipitating or perpetuating factors influencing their mood problems.
This study aims to assess the effectiveness of a brief Imagery-focussed Cognitive Therapy (imCT) compared to psychoeducation, regarded as treatment as usual for this patient population, in patients suffering from BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU. The investigators hypothesise that (1a) mood variability (primary outcome variable) and (1b) symptoms of depression, mania and anxiety (secondary outcome variables) show stronger decreases in BD patients receiving imCT than in patients receiving psychoeducation/TAU. Moreover, (2) in the imCT group this effect is expected to be mediated by changes in imagery which is targeted during this intervention (target imagery). The investigators also hypothese that (3) imagery frequency and compellingness and vividness of imagery reduce more in the imCT group than in the group receiving psychoeducation/TAU. The primary outcome variable, mood variability, is calculated using daily mood measurements, during a 4-week baseline, during the invention and after the end of intervention until follow up at 16 weeks, in both imCT and psychoeducation/TAU. Most secondary outcome variables are assessed using weekly online questionnaires, pre-and post intervention and at 8 and 16 weeks follow-up, anxiety is calculated both weekly online and using daily measurements (see below).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between groups, comparing Imagery-Focussed therapy with psychoeducation/TAU/within group, comparing baseline phase with treatment phase.
| Arm | Type | Receives |
|---|---|---|
| psychoeducation/TAU | Active comparator | Other: TAUTAU consists of psycho-education for a period of 12 weeks, consisting of 6 2-hour sessions. Psycho-education is offered in groups, |
| imCT intervention | Experimental | Other: imagery-focused Cognitive TherapyFor a period of 12 weeks, 12 1-hour sessions of imagery-focused Cognitive Therapy delivered weekly by a trained therapists, divided in an in depth identification (4 sessions) of images followed by imagery interventions, (6 sessions) and a consolidation phase (2 sessions). |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-68
- Sufficient Dutch language ability to permit the assessment to be completed.
- Diagnosis of DB (I or II or NOS) according to DSM-5 (clinicians assessment).
- Willing to complete daily and weekly monitoring throughout the duration of the study.
- Successful completion of the daily monitoring in the 4 weeks active run-in phase.
Key exclusion criteria (6 listed)
- Learning difficulties, organic brain disease or severe neurological impairment.
- Current severe substance or alcohol misuse (clinicians assessment).
- Current manic episode as diagnosed by DSM-5
- Current active psychotic symptoms
- Presence of active suicidal risk as indicated by a score of 2 or more on item 12 (i.e. frequent thought and/or plans to end their life) of the QIDS (Rush et al., 2003) confirmed by convergent clinical opinion.
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 |
|---|---|---|
| imagery-focused Cognitive TherapyAlso: ImCTIn depth identification phase: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus. Imagery interventions: The imagery intervention consists of metacognitive imagery rescripting or promoting positive imagery or competing tasks (or a combination of these). Consolidation: Consist of fine tuning the strategies, relapse prevention using a video diary. | Other | imCT intervention |
| TAUAlso: PsychoeducationPsycho-education is offered in groups, using the format described by Honig (Postma, Honig, \& van Gent, 2008). | Other | psychoeducation/TAU |
Primary outcome
Change from baseline Mood variability to follow up at 16 weeks after end of intervention
Time frame: The ALS-18 is administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.
Mood variability is measured using the Affect Lability Score Short Version (ALS-18; Oliver \& Simons, 2004). The ALS-18 is a self-report scale measuring lability in affect and consists of 18 items. Ratings are made on a 4-point scale with a maximum score of 72. Scores range from A= very characteristic of me (4 points), to D= very uncharacteristic of me (1 point).
7 secondary outcomes
Change from baseline Level of depression to follow up at to follow up at 16 weeks
Time frame: measured weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU).
Change from baseline level of mania to follow up at 16 weeks
Time frame: measured weekly throughout the duration of the study in both groups ( 32 weeks imCT and 26 weekspsychoeducation/TAU).
Change from baseline level of anxiety to follow up at 16 weeks
Time frame: measured both daily and weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU)
Change from baseline level of hopelessness to follow up at 16 weeks follow up
Time frame: measured at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention after 6 weeks in the psychoeduc condition and 12 weeks in the ImCT condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
Change from baseline level of general functioning and coping to follow up at 16 weeks
Time frame: Participants rate their level of functioning at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention12 weeks in the ImCT condition and 6 weeks in the psychoeducation condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
Change from baseline level of mood variability to follow up at 16 weeks
Time frame: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
Change from baseline level of anxiety to follow up at 16 weeks
Time frame: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
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 31 Aug 2021.
- Derived from this study: PubMed 36206888van den Berg KC, Hendrickson AT, Hales SA, Voncken M, Keijsers GPJ. Comparing the effectiveness of imagery focussed cognitive therapy to group psychoeducation for patients with bipolar disorder: A randomised trial. J Affect Disord. 2023 Jan 1;320:691-700. doi: 10.1016/j.jad.2022.09.160. Epub 2022 Oct 5.
- Applications of time-series analysis to mood fluctuations in bipolar disorder to promote treatment innovation: a case seriesLink provided by the sponsor.
- An investigation of mental imagery in bipolar disorder: Exploring "the mind's eye".Link provided by the sponsor.
- Evidence-based guidelines for treating bipolar disorder Revised third edition recommendations from the British.Link provided by the sponsor.
- Mental imagery as an emotional amplifier: application to bipolar disorderLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
karin van den Berg principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imagery-focused Cognitive Therapy and TAU in people with Bipolar Disorder, run by Maastricht University at 1 site in Netherlands.
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 31 Aug 2021. 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 Netherlands. 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 from baseline Mood variability to follow up at 16 weeks after end of intervention (time frame: The ALS-18 is administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.). 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 NCT03750305, 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 31 Aug 2021.