Initiating and Maintaining Physical Activity in Depressed Individuals

NCT02691845 | Completed

• 2 other identifiers: R01HL127695R56HL127695
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized clinical trial in which 240 depressed individuals are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:

1. 1.brief advice (BA) to exercise (control condition);
2. 2.BA + supervised \& home-based exercise (SHE) + health education (HE) contact control; and
3. 3.BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in minutes of moderate-vigorous physical activity (MVPA) per week assessed via accelerometer

  from baseline to 3 months, 6 months, 9 months

Secondary Outcomes (9)

• change in depression assessed via Quick Inventory of Depression Symptoms

  Baseline to 3 months, 6 months, 9 months

• change in cardiorespiratory fitness

  Baseline to 3 months, 6 months, 9 months

• change in self-report of MVPA assessed via International physical activity questionnaire

  Baseline to 3 months, 6 months, 9 months

• change in Self-report of pain assessed via the SF-36

  Baseline to 3 months, 6 months, 9 months

• change in Self-report of overall health assessed via the SF-36

  Baseline to 3 months, 6 months,9 months

Study Arms (3)

BA

OTHER

Brief advice to exercise. This serves as a control condition.

Behavioral: BA (brief advice)

BA + SHE + HE

ACTIVE COMPARATOR

Brief advice to exercise + supervised \& home-based exercise + health education

Behavioral: BA (brief advice); Behavioral: SHE (supervised and home-based exercise); Behavioral: HE (health education)

BA + SHE + CBEX

EXPERIMENTAL

Brief advice to exercise + supervised \& home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise

Behavioral: BA (brief advice); Behavioral: SHE (supervised and home-based exercise); Behavioral: CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)

Interventions

BA (brief advice) BEHAVIORAL

BA; BA + SHE + CBEX; BA + SHE + HE

SHE (supervised and home-based exercise) BEHAVIORAL

BA + SHE + CBEX; BA + SHE + HE

HE (health education) BEHAVIORAL

BA + SHE + HE

CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise) BEHAVIORAL

BA + SHE + CBEX

Eligibility Criteria

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

You may qualify if:

• Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for more than 6 weeks of the past 12 weeks.
• Medically cleared for MVPA, documented by a note from their primary care provider.
• No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia.
• Elevated depression symptoms. To meet criteria for elevated symptoms, participants must have a QIDS score of 8 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. -
• No current bulimia or anorexia (past 3 months); no MDD with psychotic symptoms (past 6 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition; (assessed using the SCID).
• No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months.
• Depression is not very severe, i.e., QIDS score is \<= 20.
• No suicidality requiring immediate treatment.
• Not pregnant or planning on becoming pregnant in the next year.
• Understands English sufficiently well to consent and complete study assessments.
• Aged 18-65.
• Able to make one of the 2 available exercise class times.
• Able to walk 1 mile
• Weight does not exceed 375 lbs.
• If participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MOCA). Participants are required to achieve a score within 1 SD of the mean for their age and education level to participate in the study.

Sponsors & Collaborators

• Butler Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Crisis Intervention; Helium

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Ana Abrantes, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)