Psychoeducational Groups for Adults With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337425
• Other study ID #: 2016/1885
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• confirmed ADHD diagnosis

• speaking a Scandinavian language

Exclusion Criteria:

• not able or willing to give informed consent

• psychosis

• severe learning difficulties

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Psychoeducational group therapy
The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).
• Waiting list
Waiting list and standard treatment (ADHD treatment as usual)

Other:
• Standard treatment
Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.

Locations

Country	Name	City	State
Norway	Levanger Hospital, Nord-Trøndelag Hospital Trust	Levanger	N-T
Norway	Tiller DPS - St. Olavs University Hospital	Trondheim	S-T

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Nord-Trøndelag HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Vaag JR, Lara-Cabrera ML, Hjemdal O, Gjervan B, Torgersen T. Psychoeducational groups versus waitlist in treatment of attention-deficit hyperactivity/impulsivity disorder (ADHD) in adults: a protocol for a pilot randomized waitlist-controlled multicenter trial. Pilot Feasibility Stud. 2019 Jan 23;5:17. doi: 10.1186/s40814-019-0401-1. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient satisfaction	Measured with a modified version of the Client Satisfaction Questionnaire (CSQ-8). The scale consists of 8 items measured on a scale from 1 to 4. A sum score between 8 and 32 indicate the level of satisfaction with services provided.	Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Primary	Change in general self-efficacy	Measured with General Self-Efficacy Scale (GSE-6), a short-form measure of self-efficacy. Self-efficacy is regarded as a protective factor in adapting to stress and chronic illness. The scale consists of 6 items, measured on a 4-point scale, with a possible range of 6-24.	Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Secondary	Change in ADHD-related symptoms (ASRS)	Measured with ASRS, a self-reporting scale for ADHD-related symptoms in adults. The scale consists of 18 items, based on DSM-V diagnostic criteria for ADHD. The items are measured on a 5-point scale, with a possible range of 0-72.	Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Secondary	Change in ADHD-related symptoms (SCL-9)	Measured with 9 items from the SCL-90. SCL-9 is an ADHD-specific scale, consisting of 9 items of the original 90. SCL-9 covers the specific characteristic traits of ADHD.	Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Secondary	Change in ADHD-related quality of life	Measured with AAQoL - which covers ADHD-specific quality of life and function. AAQoL consists of 29 questions measuring health related quality of life among adults with ADHD.	Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)