NCT01693237

Brief Summary

The current trial aims to investigate the impact of continuous feedback on dropout and outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1) increase adherence and 2) increase treatment outcome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

August 28, 2012

Last Update Submit

February 25, 2014

Conditions

Bulimia Nervosa (BN)Binge Eating Disorder (BED)Eating Disorder Not Otherwise Specified (EDNOS)

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Treatment adherence in the intervention period defined as a rate, i.e., number of attended therapy sessions divided by the number of planned therapy sessions. If a patient ends therapy prematurely, and this is in accordance with the therapists, the number of attended sessions will be set equal to the planned number of sessions.

    At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.

Secondary Outcomes (1)

  • Eating Disorders Examination Interview

    At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of 3 years.

Other Outcomes (5)

  • Self-Harm Inventory

    At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.

  • Outcome Rating Scale

    At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.

  • Symptom Check List-90R

    At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.

  • +2 more other outcomes

Study Arms (2)

Group psychotherapy

ACTIVE COMPARATOR

20 sessions of systemic and narrative group psychotherapy

Other: Group psychotherapy

Group psychotherapy with feedback

EXPERIMENTAL

20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.

Other: Group psychotherapy with feedback

Interventions

Group psychotherapyOTHER

20 sessions of systemic and narrative group therapy

Group psychotherapy
Group psychotherapy with feedbackOTHER

20 sessions of systemic and narrative group therapy

Group psychotherapy with feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or older.
  • BMI of minimum 20.
  • Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.

You may not qualify if:

  • Acute suicidal risk.
  • Psychosis.
  • Severe depression.
  • Abuse of alcohol, medicine and/or narcotics up to 3 months before referral.
  • Use of cannabis once a month is accepted at intake but must stop during treatment.
  • Concomitant psychotherapeutic/ psychiatric treatment outside Stolpegaard Psychotherapy Centre.
  • Severe or non-regulated physical co-morbidity.
  • Pregnancy.
  • Unable to understand Danish.
  • Previous participation in the current trial.
  • Considered unable to attend treatment sessions as planned.
  • Lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stolpegaard Psychotherapy Centre

Gentofte Municipality, 2820, Denmark

Location

Related Publications (2)

  • Davidsen AH, Poulsen S, Lindschou J, Winkel P, Trondarson MF, Waaddegaard M, Lau M. Feedback in group psychotherapy for eating disorders: A randomized clinical trial. J Consult Clin Psychol. 2017 May;85(5):484-494. doi: 10.1037/ccp0000173. Epub 2017 Mar 23.

    PMID: 28333513DERIVED

  • Davidsen AH, Poulsen S, Waaddegaard M, Lindschou J, Lau M. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial. Trials. 2014 Apr 23;15:138. doi: 10.1186/1745-6215-15-138.

    PMID: 24754974DERIVED

Related Links

MeSH Terms

Conditions

Bulimia NervosaBinge-Eating Disorder

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marianne E. Lau, D.Sci.

    Stolpegaard Psychotherapy Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 26, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

DK(1)