Clinical 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Dis

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 problem

Detailed Summary:
Sponsor: University Hospital, Ghent

Current 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)


Original 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 6 months follow-up ]

Outcome: degree of repetitive negative thinking - degree of identificationfusion/disengagement - changes in metacognitions on RNT using the TCI Temperament and Character Inventory


Current Secondary Outcome:

  • change in resting state fMRI [ Time Frame: at baseline and at the end of active treatment (12 weeks) ]
    Structural MRI and DTI fMRI combined with critique paradigm
  • 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 ]
    WHO Quality of Life Dutch version
  • 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 ]
    measured by Rosenberg Self Esteem Questionnaire Dutch version
  • change in depression and anxiety [ 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 ]
    SCS Dutch version of Self Consciousness Scale BDI-II STAI Dutch versions


Original Secondary Outcome:

  • change in resting state fMRI [ Time Frame: at baseline and at the end of active treatment (12 weeks) ]
    Structural MRI and DTI fMRI combined with critique paradigm
  • 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 6 months after follow-up ]
    WHOQoL Dutch version
  • 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 6 months after follow-up ]
    measured by Rosenberg Self Esteem Questionnaire Dutch version
  • change in depression and anxiety [ Time Frame: two weeks before active treatment,12 weeks after the start of the active treatment, 3 months after follow-up and 6 months after follow-up ]
    SCS Dutch version of Self Consciousness Scale BDI-II STAI


Information By: University Hospital, Ghent

Dates:
Date Received: November 6, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: April 14, 2017
Last Verified: April 2017