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Psychoeducational Groups for Adults With ADHD

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ClinicalTrials.gov Identifier: NCT03337425
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Helse Nord-Trøndelag HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Psychoeducational group therapy Behavioral: Waiting list Other: Standard treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: a Norwegian multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: psychoeducational groups
Psychoeducational group therapy and standard treatment (ADHD treatment as usual)
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).

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.
Other Name: Treatment as usual

Active Comparator: Waiting list
Waiting list and standard treatment (ADHD treatment as usual)
Behavioral: 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.
Other Name: Treatment as usual




Primary Outcome Measures :
  1. Change in patient satisfaction [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    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.

  2. Change in general self-efficacy [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    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 :
  1. Change in ADHD-related symptoms (ASRS) [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    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.

  2. Change in ADHD-related symptoms (SCL-9) [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    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.

  3. Change in ADHD-related quality of life [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    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.



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337425


Contacts
Contact: Jonas Rennemo Vaag, phd +47 40048820 jonas.vaag@ntnu.no
Contact: Terje Torgersen, phd +47 93419909 terje.torgersen@ntnu.no

Locations
Norway
Levanger Hospital, Nord-Trøndelag Hospital Trust Recruiting
Levanger, N-T, Norway
Contact: Bjørn Gjervan, Ph.D    +4790612042    bgjervan@gmail.com   
Tiller DPS - St. Olavs University Hospital Recruiting
Trondheim, S-T, Norway, 7040
Contact: Mariela Lara, phd    +4748280188    Cabrera.Mariela.Loreto.Lara@stolav.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Nord-Trøndelag HF
Investigators
Study Director: Gunnar Morken, prof Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03337425     History of Changes
Other Study ID Numbers: 2016/1885
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

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

Keywords provided by Norwegian University of Science and Technology:
Psychotherapy, group
Adults

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms