Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

Dartmouth-Hitchcock Medical Center19 enrolled

Overview

The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Depression Obesity

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * English-speaking * Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV) * Body Mass Index (BMI) greater than or equal to 30 * Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study) Exclusion Criteria: * current substance dependence * history of psychotic symptoms * high risk of suicide/self-harm * current enrollment in a weight-loss program * weight loss surgery in the past year * current psychotherapy * inability to postpone weight loss or depression treatment interventions for the duration of the study * taking antipsychotic, tricyclic, or oral corticosteroid medication * unwilling to be randomized to the study treatments

Outcomes

Primary Outcomes

Change in clinician assessed depression symptoms

As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)

Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

Change in self-reported depression symptoms

As assessed by Patient Health Questionnaire-9 (PHQ-9)

Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

Secondary Outcomes

Change in fasting Lipids

Time frame: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.

Change in systolic and diastolic blood pressure

Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

Change in fasting blood glucose

Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)

Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)

Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)

Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)

Time frame: At post-treatment (immediately following the three-month intervention)

Change in weight

Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).

Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

Change in self-reported physical activity

Time frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.

Change in cardiovascular fitness as assessed by six-minute walk test

Time frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.

Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes