Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT01098058
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2010-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
South London and Maudsley NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Proof of Concept Randomised Controlled Trial to Examine the Potential Efficacy, Patient Acceptability and Feasibility of Cognitive-behavioural Therapy for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the effectiveness of cognitive-behavioural therapy (CBT) plus treatment as usual with treatment as usual only in treating adults with attention deficit hyperactivity disorder (ADHD).
Detailed Description:
Approximately 50% of individuals with adult ADHD are not able to tolerate, do not respond to, or fail to reach optimal outcomes on medication alone (Spencer, Biederman and Wilens 2000). The NICE guidelines for adult ADHD, released in September 2008, emphasise the need for further such research into psychological approaches to treatment of the condition.
There is promising preliminary evidence that suggests that psychological approaches to treatment are effective in individuals with Adult ADHD (see Weiss et al 2008 for a review). So far, however, only one randomised controlled trial of CBT has been carried out (Safren, Otto et al 2005). Thirty-one participants were randomised to receive either CBT and medication as usual or medication alone. Those randomised to CBT (n=16) had significantly lower ADHD symptoms (as rated by an independent investigator), global severity and self-rated symptoms than those on medication only (ps range \<0.01 to \<0.002). Those in the CBT group also had significantly lower scores on independently- and self-rated measures of mood (ps range \<0.01 to 0.04).
There is a need for more randomised controlled trials to be carried out in order to replicate Safren et al's result in a different site, to further investigate the feasibility of CBT in this population and to further develop CBT approaches to this condition.
Studies carried out so far have tended to be skills-based (i.e. sessions focused on teaching specific skills such as time management), rather than formulation-driven (a formulation is essentially a shared hypothesis as to the relationships between the individual's experience, beliefs, behaviour and emotions).
The current study aims to evaluate a formulation-driven approach to CBT for adults with ADHD. A group of individuals (n = 30) receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only (n= 30), employing a randomized design.
There is promising preliminary evidence that suggests that psychological approaches to treatment are effective in individuals with Adult ADHD (see Weiss et al 2008 for a review). So far, however, only one randomised controlled trial of CBT has been carried out (Safren, Otto et al 2005). Thirty-one participants were randomised to receive either CBT and medication as usual or medication alone. Those randomised to CBT (n=16) had significantly lower ADHD symptoms (as rated by an independent investigator), global severity and self-rated symptoms than those on medication only (ps range \<0.01 to \<0.002). Those in the CBT group also had significantly lower scores on independently- and self-rated measures of mood (ps range \<0.01 to 0.04).
There is a need for more randomised controlled trials to be carried out in order to replicate Safren et al's result in a different site, to further investigate the feasibility of CBT in this population and to further develop CBT approaches to this condition.
Studies carried out so far have tended to be skills-based (i.e. sessions focused on teaching specific skills such as time management), rather than formulation-driven (a formulation is essentially a shared hypothesis as to the relationships between the individual's experience, beliefs, behaviour and emotions).
The current study aims to evaluate a formulation-driven approach to CBT for adults with ADHD. A group of individuals (n = 30) receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only (n= 30), employing a randomized design.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: