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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 (Drop It)

Primary Purpose

Repetitive Negative Thinking, General Anxiety Disorder, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Drop It training session
treatment as usual
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Repetitive Negative Thinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

active treatment condition (ATC)

waiting list control

Arm Description

training protocol 'drop it'

no treatment other than treatment as usual

Outcomes

Primary Outcome Measures

change in repetitive negative thinking
degree of repetitive negative thinking (PSWQ Dutch version)
change in repetitive negative thinking
degree of repetitive negative thinking (LARRS)
change in repetitive negative thinking
changes in metacognitions on RNT (MCV Dutch version of MCQ)
change in repetitive negative thinking
degree of identification/disengagement (CFQ-13)
change in repetitive negative thinking
degree of identification/disengagement (VAS)

Secondary Outcome Measures

change in resting state fMRI
Structural MRI and DTI fMRI combined with critique paradigm
change in Quality of Life
WHO Quality of Life Dutch version
change in self-esteem
measured by Rosenberg Self Esteem Questionnaire Dutch version
change in depression and anxiety
BDI-II, STAI Dutch versions
change in personality features
using the TCI (Temperament and Character Inventory)

Full Information

First Posted
November 6, 2013
Last Updated
May 23, 2017
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01983033
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Repetitive Negative Thinking, General Anxiety Disorder, Depressive Disorder, Depression, Anxiety Disorders, Worrying, Rumination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active treatment condition (ATC)
Arm Type
Experimental
Arm Description
training protocol 'drop it'
Arm Title
waiting list control
Arm Type
Other
Arm Description
no treatment other than treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Drop It training session
Intervention Description
8 training sessions in group, sessions of 90 minutes, 7 sessions weekly, plus 1 session after 1 month
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
12 weeks of no intervention other than treatment as usual
Primary Outcome Measure Information:
Title
change in repetitive negative thinking
Description
degree of repetitive negative thinking (PSWQ Dutch version)
Time Frame
at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Title
change in repetitive negative thinking
Description
degree of repetitive negative thinking (LARRS)
Time Frame
at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Title
change in repetitive negative thinking
Description
changes in metacognitions on RNT (MCV Dutch version of MCQ)
Time Frame
at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Title
change in repetitive negative thinking
Description
degree of identification/disengagement (CFQ-13)
Time Frame
at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Title
change in repetitive negative thinking
Description
degree of identification/disengagement (VAS)
Time Frame
at baseline, at the end of active treatment (12 weeks), at 3 months follow-up and at 9 months follow-up
Secondary Outcome Measure Information:
Title
change in resting state fMRI
Description
Structural MRI and DTI fMRI combined with critique paradigm
Time Frame
at baseline and at the end of active treatment (12 weeks)
Title
change in Quality of Life
Description
WHO Quality of Life Dutch version
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
Title
change in self-esteem
Description
measured by Rosenberg Self Esteem Questionnaire Dutch version
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
Title
change in depression and anxiety
Description
BDI-II, STAI Dutch versions
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
Title
change in personality features
Description
using the TCI (Temperament and Character Inventory)
Time Frame
two weeks before active treatment/waiting list, 12 weeks after the start of the active treatment/waiting list

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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