Physical Exercise Augmented CBT for GAD

NCT ID: NCT02690441

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT augmented with physical exercise

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

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

Physical Exercise

Intervention Type: BEHAVIORAL

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

CBT and placebo control

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioural Therapy

Intervention Type: BEHAVIORAL

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

Placebo control

Intervention Type: 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.

Interventions

Cognitive Behavioural Therapy

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

Intervention Type: BEHAVIORAL

Physical Exercise

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

Intervention Type: BEHAVIORAL

Placebo control

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Telephone follow-up

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: collaborator

William Paterson University of New Jersey

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Solli Distriktspsykiatriske Senter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Hovland, PhD

Role: PRINCIPAL_INVESTIGATOR

Solli DPS, University of Bergen

Locations

Solli DPS

Bergen, Nesttun, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37468978 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30885256 (View on PubMed)

Other Identifiers

971427272T1

Identifier Type: -

Identifier Source: org_study_id