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

Depression Clinical Trial

— Drop It  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983033
• Other study ID #: 2013/708
• Secondary ID: B670201318392
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: May 23, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• GAD

• depression or depression in remission

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease
• General Anxiety Disorder
• Repetitive Negative Thinking
• Rumination
• Worrying

Intervention

Behavioral:
• Drop It training session
8 training sessions in group, sessions of 90 minutes, 7 sessions weekly, plus 1 session after 1 month
• treatment as usual
12 weeks of no intervention other than treatment as usual

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in repetitive negative thinking	degree of repetitive negative thinking (PSWQ Dutch version)	at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Primary	change in repetitive negative thinking	degree of repetitive negative thinking (LARRS)	at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Primary	change in repetitive negative thinking	changes in metacognitions on RNT (MCV Dutch version of MCQ)	at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Primary	change in repetitive negative thinking	degree of identification/disengagement (CFQ-13)	at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Primary	change in repetitive negative thinking	degree of identification/disengagement (VAS)	at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Secondary	change in resting state fMRI	Structural MRI and DTI fMRI combined with critique paradigm	at baseline and at the end of active treatment (12 weeks)
Secondary	change in Quality of Life	WHO Quality of Life Dutch version	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
Secondary	change in self-esteem	measured by Rosenberg Self Esteem Questionnaire Dutch version	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
Secondary	change in depression and anxiety	BDI-II, STAI Dutch versions	two weeks before active treatment/waiting list, 12 weeks after active treatment/waiting list, follow-up 3 and 9 months after active treatment
Secondary	change in personality features	using the TCI (Temperament and Character Inventory)	two weeks before active treatment/waiting list, 12 weeks after the start of the active treatment/waiting list