Repetitive Negative ThinkingDrop ItNCT01983033
Training Protocol 'Drop it'. The Impact of a Training Protocol Focused on Coping With Negative Repetitive Thinking on Cognitive and Behavioural Functioning of People Suffering From GAD or Minor or Moderate Depressive Disorder or Depressive Disorder in Remission
A study testing Drop It training session and treatment as usual in people with Repetitive Negative Thinking and General Anxiety Disorder, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Repetitive negative thinking (RNT) plays an important role in different psychiatric disorders, such as depressive and anxiety disorders, complicated grief, posttraumatic stress disorders, anorexia nervosa. RNT is seen as a vulnerability factor in the onset, duration, severity and relapse of those disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Repetitive Negative Thinking, General Anxiety Disorder, Depressive Disorder
- What is being tested?
- Drop It training session and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Dec 2016
- 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
- GAD
- depression or depression in remission
Who cannot join
- other psychiatric pathology than GAD or depression screened by senior psychiatrist by means of MINI and psychiatric anamnesis
- Abuse of alcohol, drugs or medication other than prescribed by GP or psychiatrist
- no consent to participate in measurement (questionnaire or fMRI- for fMRI: except medical contra-indications)
- Insufficient knowledge of the current language (Dutch)
- Acute or chronic suicidality
- Acute psychosis or manic depressive disorder
- Not able to commit for the 8 sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drop it. The Impact of a Training Protocol Focused on Coping With Negative Repetitive Thinking on Cognitive and Behavioural Functioning of People Suffering From GAD or Minor or Moderate Depressive Disorder or Depressive Disorder in Remission
Repetitive negative thinking (RNT) plays an important role in different psychiatric disorders, such as depressive and anxiety disorders, complicated grief, posttraumatic stress disorders, anorexia nervosa. RNT is seen as a vulnerability factor in the onset, duration, severity and relapse of those disorders. Although there is a lot of theoretical research, it is unknown if a group training protocol addressing RNT has an additional effect on Treatment as Usual (TAU) of patients with GAD or Depressive disorder. Our hypothesis is that a training intervention will show a significant effect on declined RNT activity (measured by PSWQ and LARRS), reduced identification with worrying/rumination (measured by CFQ-13 and a Visual Analogue Scale), and reduced scores on metacognitions questionnaire (MCV Dutch version of the MCQ), when compared to TAU (medication, psychotherapy or a combination of both treatments). Further we expect that this effect on RNT will not be temporary and the beneficial effects will remain present over a longer time (9 months). Our third hypothesis claims that reduced RNT will have an effect on Quality of Life, self-esteem and depressive and anxiety scores (measured respectively by WHO-QoL, Rosenberg Self Esteem Questionnaire, BDI-II and STAI; all of them in Dutch version). Fourth hypothesis concerns the effect of the training in the functioning on a neurobiological level. Here we expect that the beneficial effects of training on RNT will increase top-down prefrontal (dorsolateral) cortical control over an overactive bottom-up limbic system. To examine these neurobiological effects, we apply a multimodal approach where we combine resting state fMRI, structural MRI such as diffuse tensor imaging (DTI), anterior spin labelling (ASL). Further, in our department we developed an audio critique task where participants hear different kinds of critique amongst some of negative valence which will be especially problematic for ruminative patients reflecting difficulties and differences these top-down/bottom-up processes when compared to a healthy control group at baseline. Further, we hypothesize that only when coping with RNT is successful these neuronal processes will normalize. We do not expect changes in the waiting list group.
To examine these clinical and neuronal effects, people suffering from GAD and/or depression will be allocated by randomisation to an active treatment condition (ATC) and a waiting list control group (WLC). All the participants will be patients treated by general practitioner, psychologist or psychiatrist. Training exists of 8 sessions in group (max 12 participants) on a weekly basis, except for the last session, which takes place after one month). During the training people will get information on RNT, they will be trained in re-allocation of their attention, will receive some basic ideas about becoming aware of dysfunctional thinking and learn coping strategies such as stimulus control and engaging in positive activity.
Read more
Assessments will take place before and after treatment for the ATC. The WLC will be measured at the start of the WLC and 12 weeks later. Measurement takes place by means of questionnaires and fMRI. During the fMRI, people will undergo a resting state paradigm and some tasks triggering RNT. 3 and 9 months after the group treatment, participants will be evaluated again on RNT by means of questionnaires. Participants in WLC will receive group treatment from the moment the parallel active treatment condition is ended (e.g. after 12 weeks). This group will be evaluated immediately after training and at 3 and 9 months follow-up.
At the end of the training, after the 8th session, two participants per run will be asked to cooperate in a qualitative in-depth interview. We are interested in linking results with the group training with some factors such as quantity of sessions, degree of active participation in between sessions. We are also interested in defining which interventions are perceived as most useful and if there is a link between disorder and the usefulness of some interventions.
- Conditions
- Repetitive Negative Thinking, General Anxiety Disorder, Depressive Disorder, Depression, Anxiety Disorders, Worrying
- Being tested
- Drop It training session, treatment as usual
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Depression, Anxiety Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drop It training sessionBehavioural
8 training sessions in group, sessions of 90 minutes, 7 sessions weekly, plus 1 session after 1 month
treatment as usualBehavioural
12 weeks of no intervention other than treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| active treatment condition (ATC) | Experimental | training protocol 'drop it' Receives: Behavioral: Drop It training session |
| waiting list control | Other | no treatment other than treatment as usual Receives: Behavioral: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in repetitive negative thinking
degree of repetitive negative thinking (PSWQ Dutch version)
Measured: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
change in repetitive negative thinking
degree of repetitive negative thinking (LARRS)
Measured: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
change in repetitive negative thinking
changes in metacognitions on RNT (MCV Dutch version of MCQ)
Measured: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
change in repetitive negative thinking
degree of identification/disengagement (CFQ-13)
Measured: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
change in repetitive negative thinking
degree of identification/disengagement (VAS)
Measured: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Secondary outcomes (5)
change in resting state fMRI
Structural MRI and DTI fMRI combined with critique paradigm
Measured: at baseline and at the end of active treatment (12 weeks)
change in Quality of Life
WHO Quality of Life Dutch version
Measured: two weeks before active treatment,12 weeks after the start of the active treatment, 3 months after follow-up and 9 months after follow-up
change in self-esteem
measured by Rosenberg Self Esteem Questionnaire Dutch version
Measured: two weeks before active treatment,12 weeks after the start of the active treatment, 3 months after follow-up and 9 months after follow-up
change in depression and anxiety
BDI-II, STAI Dutch versions
Measured: two weeks before active treatment/waiting list, 12 weeks after active treatment/waiting list, follow-up 3 and 9 months after active treatment
change in personality features
using the TCI (Temperament and Character Inventory)
Measured: two weeks before active treatment/waiting list, 12 weeks after the start of the active treatment/waiting list
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Negative ThinkingStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983033
- Sponsor's protocol ID
- 2013/708
- Other IDs
- B670201318392
- Acronym
- Drop It
- Status last verified
- May 2017
- First submitted
- 6 Nov 2013
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drop it. The Impact of a Training Protocol Focused on Coping With Negative Repetitive Thinking on Cognitive and Behavioural Functioning of People Suffering From GAD or Minor or Moderate Depressive Disorder or Depressive Disorder in Remission
- ClinicalTrials.gov ID
- NCT01983033
- Acronym / sponsor ID
- Drop It / 2013/708
- Conditions
- Repetitive Negative Thinking, General Anxiety Disorder, Depressive Disorder, Depression, Anxiety Disorders, Worrying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Nov 2013 (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.
Repetitive negative thinking (RNT) plays an important role in different psychiatric disorders, such as depressive and anxiety disorders, complicated grief, posttraumatic stress disorders, anorexia nervosa. RNT is seen as a vulnerability factor in the onset, duration, severity and relapse of those disorders. Although there is a lot of theoretical research, it is unknown if a group training protocol addressing RNT has an additional effect on Treatment as Usual (TAU) of patients with GAD or Depressive disorder. Our hypothesis is that a training intervention will show a significant effect on declined RNT activity (measured by PSWQ and LARRS), reduced identification with worrying/rumination (measured by CFQ-13 and a Visual Analogue Scale), and reduced scores on metacognitions questionnaire (MCV Dutch version of the MCQ), when compared to TAU (medication, psychotherapy or a combination of both treatments). Further we expect that this effect on RNT will not be temporary and the beneficial effects will remain present over a longer time (9 months). Our third hypothesis claims that reduced RNT will have an effect on Quality of Life, self-esteem and depressive and anxiety scores (measured respectively by WHO-QoL, Rosenberg Self Esteem Questionnaire, BDI-II and STAI; all of them in Dutch version). Fourth hypothesis concerns the effect of the training in the functioning on a neurobiological level. Here we expect that the beneficial effects of training on RNT will increase top-down prefrontal (dorsolateral) cortical control over an overactive bottom-up limbic system. To examine these neurobiological effects, we apply a multimodal approach where we combine resting state fMRI, structural MRI such as diffuse tensor imaging (DTI), anterior spin labelling (ASL). Further, in our department we developed an audio critique task where participants hear different kinds of critique amongst some of negative valence which will be especially problematic for ruminative patients reflecting difficulties and differences these top-down/bottom-up processes when compared to a healthy control group at baseline. Further, we hypothesize that only when coping with RNT is successful these neuronal processes will normalize. We do not expect changes in the waiting list group.
To examine these clinical and neuronal effects, people suffering from GAD and/or depression will be allocated by randomisation to an active treatment condition (ATC) and a waiting list control group (WLC). All the participants will be patients treated by general practitioner, psychologist or psychiatrist. Training exists of 8 sessions in group (max 12 participants) on a weekly basis, except for the last session, which takes place after one month). During the training people will get information on RNT, they will be trained in re-allocation of their attention, will receive some basic ideas about becoming aware of dysfunctional thinking and learn coping strategies such as stimulus control and engaging in positive activity.
Assessments will take place before and after treatment for the ATC. The WLC will be measured at the start of the WLC and 12 weeks later. Measurement takes place by means of questionnaires and fMRI. During the fMRI, people will undergo a resting state paradigm and some tasks triggering RNT. 3 and 9 months after the group treatment, participants will be evaluated again on RNT by means of questionnaires. Participants in WLC will receive group treatment from the moment the parallel active treatment condition is ended (e.g. after 12 weeks). This group will be evaluated immediately after training and at 3 and 9 months follow-up.
At the end of the training, after the 8th session, two participants per run will be asked to cooperate in a qualitative in-depth interview. We are interested in linking results with the group training with some factors such as quantity of sessions, degree of active participation in between sessions. We are also interested in defining which interventions are perceived as most useful and if there is a link between disorder and the usefulness of some interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active treatment condition (ATC) | Experimental | Behavioral: Drop It training sessiontraining protocol 'drop it' |
| waiting list control | Other | Behavioral: treatment as usualno treatment other than treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GAD
- depression or depression in remission
Key exclusion criteria (7 listed)
- other psychiatric pathology than GAD or depression screened by senior psychiatrist by means of MINI and psychiatric anamnesis
- Abuse of alcohol, drugs or medication other than prescribed by GP or psychiatrist
- no consent to participate in measurement (questionnaire or fMRI- for fMRI: except medical contra-indications)
- Insufficient knowledge of the current language (Dutch)
- Acute or chronic suicidality
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 |
|---|---|---|
| Drop It training session8 training sessions in group, sessions of 90 minutes, 7 sessions weekly, plus 1 session after 1 month | Behavioural | active treatment condition (ATC) |
| treatment as usual12 weeks of no intervention other than treatment as usual | Behavioural | waiting list control |
Primary outcome
change in repetitive negative thinking
Time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
degree of repetitive negative thinking (PSWQ Dutch version)
change in repetitive negative thinking
Time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
degree of repetitive negative thinking (LARRS)
change in repetitive negative thinking
Time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
changes in metacognitions on RNT (MCV Dutch version of MCQ)
change in repetitive negative thinking
Time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
degree of identification/disengagement (CFQ-13)
change in repetitive negative thinking
Time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
degree of identification/disengagement (VAS)
5 secondary outcomes
change in resting state fMRI
Time frame: at baseline and at the end of active treatment (12 weeks)
change in Quality of Life
Time frame: two weeks before active treatment,12 weeks after the start of the active treatment, 3 months after follow-up and 9 months after follow-up
change in self-esteem
Time frame: two weeks before active treatment,12 weeks after the start of the active treatment, 3 months after follow-up and 9 months after follow-up
change in depression and anxiety
Time frame: two weeks before active treatment/waiting list, 12 weeks after active treatment/waiting list, follow-up 3 and 9 months after active treatment
change in personality features
Time frame: two weeks before active treatment/waiting list, 12 weeks after the start of the active treatment/waiting list
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 25 May 2017.
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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 Drop It training session and treatment as usual in people with Repetitive Negative Thinking and General Anxiety Disorder, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 7 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 25 May 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 Belgium. 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 repetitive negative thinking (time frame: at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up). The study lists 5 primary outcomes in all. 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 25 May 2017.