Clinical trial NCT02690441: Physical Exercise Augmented CBT for GAD
Official title: Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: GAD
CBT
Physical exercise
Older adults
Lead sponsor: Solli Distriktspsykiatriske Senter
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Norwegian University of Science and Technology
name: University of Oslo
name: University of California, Berkeley
name: William Paterson University of New Jersey
name: Ohio State University
First posted: 2016-02-24
Enrollment: 53
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. However, recommended treatment for GAD has consistently been found to yield blunted response rates for older adults compared to younger patients.

The purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield better results than standard CBT in terms of greater reduction of symptoms and increased rates of remission. The investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of GAD

Exclusion Criteria:

* Substance abuse
* Use of benzodiazepines, use of antipsychotica
* Lack of ability to stabilize other psychotropic medication during participating in the study
* Medical condition that precludes participation in physical exercise
* Severe major depression as determined by the MINI International Neuropsychiatric Interview
* Life-time history of psychosis and/or mania
* Participation in other ongoing psychotherapy
* Organic brain disease
* Positive screening for dementia with Mini Mental State Examination
* Currently engaged in a regular physical exercise program

Primary outcomes:
measure: Changes in The Penn State Worry Questionnaire
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)
timeFrame: Baseline and post-treatment (up to 20 weeks after baseline)
Secondary outcomes:
measure: Geriatric Anxiety Inventory
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Beck Anxiety Inventory
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Beck Depression Inventory - II
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Bergen Insomnia Scale
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Quality of Life Inventory
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: 5-item Treatment Credibility and Expectancy Scale (CES)
timeFrame: Baseline
Other outcomes:
measure: Function and structure of prefrontal lobes and limbic system
timeFrame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
measure: Blood samples
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Saliva samples
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001)
timeFrame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
measure: Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003).
timeFrame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
measure: The California Verbal Learning Test (CVLT; Delis, Kramer & Kaplan, 1994).
timeFrame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
measure: Wechsler Abbreviated Scale of Intelligence
timeFrame: Baseline
measure: Ambulatory Electrocardiogram (ECG)
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Ekblom-Bak submaximal ergometer cycle test
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
measure: Strength test battery
timeFrame: Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
Locations:
city: Bergen
country: Norway
facility: Solli DPS
state: Nesttun
Study officials:
affiliation: Solli DPS, University of Bergen
name: Anders Hovland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stavestrand SH, Sirevag K, Nordhus IH, Sjobo T, Endal TB, Nordahl HM, Specht K, Hammar A, Halmoy A, Martinsen EW, Andersson E, Hjelmervik H, Mohlman J, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial. Trials. 2019 Mar 18;20(1):174. doi: 10.1186/s13063-019-3268-9.