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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02889354
Other study ID # KI-2016/255-31/5
Secondary ID
Status Completed
Phase N/A
First received August 31, 2016
Last updated August 22, 2017
Start date August 2016
Est. completion date June 2017

Study information

Verified date August 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility and acceptability in a pilot study with a single group design. The study also evaluates measurements and recruiting possibilities, and effects of the intervention. Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and reasonable in regards to patient characteristics; that is, the patients are responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of treatment completion, compliance to home assignments, and credibility and relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and anxiety, and improves quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

In addition to an ADHD inattentive-type diagnosis, inclusion criteria are:

1. 18 years or older,

2. intelligence quotient above 80-85, and

3. if on medication, it needs to be well-established since three months.

Exclusion Criteria:

1. autism spectrum disorder,

2. ongoing substance use disorder,

3. difficulties in compliance with medical or other treatment,

4. social and/or psychiatric problems to such an extent that it prevents focusing on treatment, or

5. ongoing cognitive-behavioral therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive-behavioral therapy


Locations

Country Name City State
Sweden Capio Psykiatri AB Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brown ADD Scales Diagnostic measure 14 weeks
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