Physical Exercise Augmented CBT for GAD

NCT02690441 | Active Not Recruiting

• 1 other identifier: 971427272T1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

GAD; CBT; Physical exercise; Older adults

Outcome Measures

Primary Outcomes (2)

• Changes in The Penn State Worry Questionnaire

  Assesses symptom severity of GAD

  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

• Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

  Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

  Baseline and post-treatment (up to 20 weeks after baseline)

Secondary Outcomes (8)

• Geriatric Anxiety Inventory

  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

• Generalized Anxiety Disorder 7-item scale (GAD-7)

  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

• Beck Anxiety Inventory

  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

• Beck Depression Inventory - II

  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

• Bergen Insomnia Scale

  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

Other Outcomes (10)

• Function and structure of prefrontal lobes and limbic system

  Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up

• Blood samples

  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

• Saliva samples

  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

Study Arms (2)

CBT augmented with physical exercise

EXPERIMENTAL

Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of physical exercise pre-treatment, and 10 weeks of physical exercise alongside CBT. Both treatment and physical exercise is administered individually.

Behavioral: Cognitive Behavioural Therapy; Behavioral: Physical Exercise

CBT and placebo control

ACTIVE COMPARATOR

Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of placebo control (15 minutes telephone follow-up call each week) pre-treatment, and 10 weeks of attention placebo alongside CBT. Both treatment and placebo control is administered individually.

Behavioral: Cognitive Behavioural Therapy; Behavioral: Placebo control

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.

CBT and placebo control; CBT augmented with physical exercise

Physical Exercise BEHAVIORAL

Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.

CBT augmented with physical exercise

Placebo control BEHAVIORAL

One follow-up telephone call à 15 minutes each week for 15 weeks. Aims to control for therapist contact in physical exercise condition and total duration of treatment.

Also known as: Telephone follow-up

CBT and placebo control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of GAD

You may not qualify if:

• 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

Sponsors & Collaborators

• Solli Distriktspsykiatriske Senter: lead
• University of Bergen: collaborator
• Norwegian University of Science and Technology: collaborator
• University of Oslo: collaborator
• University of California, Berkeley: collaborator
• William Paterson University of New Jersey: collaborator
• Ohio State University: collaborator

Study Sites (1)

Solli DPS

Bergen, Nesttun, 5228, Norway

Location

Related Publications (2)

• Sirevag K, Stavestrand SH, Sjobo T, Endal TB, Nordahl HM, Andersson E, Nordhus IH, Rekdal A, Specht K, Hammar A, Halmoy A, Mohlman J, Hjelmervik H, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): a feasibility study for a randomized controlled trial. Biopsychosoc Med. 2023 Jul 19;17(1):25. doi: 10.1186/s13030-023-00280-7.

  PMID: 37468978 DERIVED

• 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.

  PMID: 30885256 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Motor Activity

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anders Hovland, PhD

  Solli DPS, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)