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Psychoeducational Groups for Adults With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychoeducational group therapy
Waiting list
Standard treatment
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Psychotherapy, group, Adults

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

Exclusion Criteria:

  • not able or willing to give informed consent
  • psychosis
  • severe learning difficulties

Sites / Locations

  • Levanger Hospital, Nord-Trøndelag Hospital Trust
  • Tiller DPS - St. Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

psychoeducational groups

Waiting list

Arm Description

Psychoeducational group therapy and standard treatment (ADHD treatment as usual)

Waiting list and standard treatment (ADHD treatment as usual)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 2, 2017
Last Updated
July 14, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF
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1. Study Identification

Unique Protocol Identification Number
NCT03337425
Brief Title
Psychoeducational Groups for Adults With ADHD
Official Title
Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Psychotherapy, group, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
a Norwegian multicenter study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
psychoeducational groups
Arm Type
Experimental
Arm Description
Psychoeducational group therapy and standard treatment (ADHD treatment as usual)
Arm Title
Waiting list
Arm Type
Active Comparator
Arm Description
Waiting list and standard treatment (ADHD treatment as usual)
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational group therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Waiting list
Intervention Description
Waiting list and standard treatment (ADHD treatment as usual)
Intervention Type
Other
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient satisfaction
Description
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.
Time Frame
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Title
Change in general self-efficacy
Description
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.
Time Frame
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Secondary Outcome Measure Information:
Title
Change in ADHD-related symptoms (ASRS)
Description
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.
Time Frame
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Title
Change in ADHD-related symptoms (SCL-9)
Description
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.
Time Frame
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Title
Change in ADHD-related quality of life
Description
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.
Time Frame
Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: confirmed ADHD diagnosis speaking a Scandinavian language Exclusion Criteria: not able or willing to give informed consent psychosis severe learning difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terje Torgersen, phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hospital, Nord-Trøndelag Hospital Trust
City
Levanger
State/Province
N-T
Country
Norway
Facility Name
Tiller DPS - St. Olavs University Hospital
City
Trondheim
State/Province
S-T
ZIP/Postal Code
7040
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30693097
Citation
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.
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Psychoeducational Groups for Adults With ADHD

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