Trials / Completed
CompletedNCT01098058
Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- South London and Maudsley NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | CBT plus treatment as usual | 16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments |
| OTHER | Treatment as usual | Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2010-04-02
- Last updated
- 2016-04-19
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01098058. Inclusion in this directory is not an endorsement.